NCT03150693ClinicalTrials.gov

Inotuzumab Ozogamicin and Frontline Chemotherapy in Treating Young Adults With Newly Diagnosed B Acute Lymphoblastic Leukemia

A Phase III Trial to Evaluate the Efficacy of the Addition of Inotuzumab Ozogamicin (a Conjugated Anti-CD22 Monoclonal Antibody) to Frontline Therapy in Young Adults (Ages 18-39 Years) With Newly Diagnosed Precursor B-Cell ALL

In reclutamentoAccetta partecipanti ora, secondo la scheda del registro.

Contatta questo studio

In breve

Fase 3303 partecipanti ricercati460 centri2 paesi

Categorie

Oncologia82%Ematologia9%Malattie infettive4%Immunologia e reumatologia4%

Registrato in 1 registro

ClinicalTrials.govNCT03150693Apri questa scheda su ClinicalTrials.govSincronizzato 3 settimane fa

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How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

Present: Registered before enrolment beganFirst posted 2017-05-12; recorded start 2017-09-20
Present: Has a defined primary outcomeA primary outcome measure is listed in the record
Present: The primary outcome states a time frameThe primary outcome measure records a time frame
Present: Participants are randomly assignedAllocation is recorded as randomised
Present: Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
Not stated: Open label (no blinding)Masking is recorded as none (open label)
Not stated: An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
Not stated: Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
Not stated: A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
Present: No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
Present: Sponsor has 95 other studies in this databaseCounted from the lead sponsor named in the record (Alliance for Clinical Trials in Oncology)
Present: Sponsor has posted results for at least one studyBased on the sponsor’s studies in this database

The record lists 1 condition.
Lead sponsor type recorded as: other.
Intervention regulatory context: investigational, within a phased regulatory pathway.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourSTRONG

A strong methodological design for a phase 3 study, judged from its ClinicalTrials.gov record.

How this score is built

Randomised allocation20/20
Participants are randomly allocated between arms
Blinding0/20
Open-label
Control arm15/15
Active-comparator control arm
Primary-outcome specificity10/10
Named primary outcome with a defined time frame
Endpoint type10/10
Mortality / MACE endpoint (hard clinical outcome)
Multi-centre8/8
Multi-centre: 460 sites
Data monitoring committee7/7
A data monitoring committee is in place
Prospective registration5/5
Registered before the study start date
Protocol / SAP posted0/5
No protocol or SAP posted to the registry

ScaleMEDIUM

A medium-sized study, international in scope: 303 participants (target), run at 460 sites, across 2 countries.

How this score is built

Enrolment24/40
303 participants (target)
Site count25/25
460 sites
Country count7/15
2 countries
Planned duration10/10
Planned over about 120 months
Sponsor scale7/10
Alliance for Clinical Trials in Oncology has led 96 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built

Investigator standing0/100
No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

Sintesi

This phase III trial studies the side effects of inotuzumab ozogamicin and how well it works when given with frontline chemotherapy in treating patients with newly diagnosed B acute lymphoblastic leukemia. Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a chemotherapy drug called ozogamicin. Inotuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as CD22 receptors, and delivers ozogamicin to kill them. Chemotherapy drugs, such as \[intervention\], work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving inotuzumab ozogamicin with chemotherapy may work better in treating young adults with B acute lymphoblastic leukemia.

PRIMARY OBJECTIVES: I. To confirm tolerability of the combination regimen with the addition of inotuzumab ozogamicin to the pediatric-inspired regimen of cancer and leukemia group B (CALGB) 10403. II. To determine whether the addition of inotuzumab ozogamicin significantly improves the event-free survival (EFS) in patients who achieve an induction response achieved with the pediatric-inspired regimen of CALGB 10403, without censoring for transplant. (Phase III) III. To determine the safety and tolerability of a reduced dose of inotuzumab ozogamicin and two cycles of blinatumomab added to the pediatric-inspired regimen of CALGB 10403 (Pilor cohort). SECONDARY OBJECTIVES: I. To determine the impact of inotuzumab ozogamicin on disease-free (DFS) and overall survival (OS) in patients who achieve an induction response. II. To determine whether the addition of inotuzumab ozogamicin significantly improves the event-free survival (EFS) in patients who achieve an induction response achieved with the pediatric-inspired regimen of CALGB 10403, with censoring for transplant. III. To determine the impact of inotuzumab ozogamicin on minimal residual disease (MRD) and correlate this with the EFS, DFS and OS. IV. To determine the prognosis based on patients' low-density array (LDA) gene signature in terms of EFS, DFS, and OS after treatment with or without inotuzumab ozogamicin when added to the C10403 backbone regimen. V. To evaluate the toxicity and tolerability of the addition of inotuzumab ozogamicin to the pediatric-inspired regimen of CALGB 10403. CORRELATIVE SCIENCE OBJECTIVES: I. To assess both the correlation of MRD post-induction and at sequential timepoints with LDA signature. II. To evaluate the influence of MRD status (detectable vs. not and as a continuous measure) in relation to EFS both in the univariate setting as well as adjusting for other clinical features including initial white blood cell (WBC), ethnicity, sex and age at diagnosis. III. To evaluate the impact of inotuzumab ozogamicin (inotuzumab) on the kinetics of MRD during treatment with inotuzumab in patients randomized to the experimental treatment arm. IV. To perform genomic analyses to identify and evaluate the incidence and clinical significance of recurring novel fusion genes including those associated with the BCR-ABL1-like signature and to correlate with MRD status, CR rate, EFS and OS. V. To assess whether rs4958351 is correlated with L-asp allergic reaction in the adolescent and young adult (AYA) population. VI. To assess the incidence of inherited genetic variants in the GR1A1, CEP72, CPA2, TPMT, NUDT15, GRIN3A, GRIK1, and other genes (which can be found using a whole genome association study \[GWAS\]), are correlated with increased rates of target toxicities including peripheral neuropathy, hepatotoxicity, pancreatitis, myelosuppression, neurotoxicity, thrombosis, and osteonecrosis, and correlate with treatment discontinuation and other clinical response parameters including complete response (CR) rate, EFS, and OS. VII. To evaluate asparaginase pharmacokinetics in adolescents and young adults, and investigate its correlation with toxicities and treatment outcomes. VIII. To investigate the effect of anti-polyethylene glycol (PEG) and anti-agouti signaling protein (ASP) antibodies (PEG-ASP) on ASP enzyme activity. IX. To measure adherence to oral 6 mercaptopurine (MP) and methotrexate in AYAs with acute lymphoblastic leukemia (ALL) and to examine sociodemographic and behavioral determinants of adherence. X. To determine the impact of adherence on risk of relapse among AYAs with ALL. XI. To correlate specific karyotype groups (normal or various primary and secondary chromosomal abnormalities) with clinical and laboratory parameters. XII. To correlate specific karyotype groups with response rates, response duration, survival, and cure in patients treated on this protocol. XIII. To correlate specific karyotype groups with MRD. XIV. To determine karyotype changes at relapse and the influence of the type of change (or no change) in karyotype at relapse. XV. To define the rate, analytical performance, and diagnostic yield of ChromoSeq vs. conventional G-banded karyotyping and fluorescence in situ hybridization (FISH) for B ALL patients in a multicenter setting. OUTLINE: COURSE I (REMISSION INDUCTION THERAPY): All patients receive allopurinol orally (PO) once daily until peripheral blasts and extramedullary disease are reduced and cytarabine intrathecally (IT) over 1 minute on day 1. Patients also receive daunorubicin hydrochloride intravenously, over 1 to 30 minutes (IV) and vincristine sulfate IV on days 1, 8, 15 and 22, dexamethasone PO or IV twice daily (BID) on days 1-7 and 15-21, pegaspargase for patients \>21.5 years IV, over 1 to 2 hours on day 4, 5, or 6, or calaspargase pegol IV, over 1 hour, on days 4, 5 or 6 and methotrexate IT over 1 minute on days 8 and 29. Patients with central nervous system (CNS) 3 disease receive methotrexate IT over 1 minute also on days 15 and 22. All patients then undergo bone marrow aspirate and biopsy on day 29. Patients enrolled prior to Update 8 with response to remission induction therapy are randomized to 1 of 2 arms. Patients enrolled after amendment 8 are assigned to the pilot cohort. Patients with no response are omitted from the study. ARM I (CLOSED 7/23/2025): COURSE II (REMISSION CONSOLIDATION CHEMOTHERAPY): Patients receive cyclophosphamide IV on days 1 and 29, cytarabine IV or SC on days 1-4, 8-11, 29-32, and 36-39, mercaptopurine PO on days 1-14 and 29-42, and vincristine sulfate IV, over 1 to 10 minutes on days 15, 22, 43, and 50. Patients \>21.5 years also receive pegaspargase IV, over 1 to 2 hours, on days 15 and 43 and patients \<21.5 years old receive calaspargase pegol IV, over 1 hour, on days 2 and 22, and methotrexate IT on days 1, 8, 15, and 22. Patients with CNS3 receive methotrexate IT only on days 1 and 8. CD20 positive (+) patients receive rituximab IV on days 1, 8, 29, and 36. Patients with evidence of testicular disease at diagnosis also receive radiation therapy (RT). Patients who are MRD+ and CD19+ after completion of this course receive dexamethasone IV or PO on day 1 and blinatumomab IV via continuous infusion on days 1-28, followed by a 14 day break. Cycles repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients then undergo bone marrow aspirate and biopsy on day 56. COURSE III (INTERIM MAINTENANCE CHEMOTHERAPY): Patients receive vincristine sulfate IV, over 1 to 10 minutes, on days 1, 11, 21, 31, and 41, methotrexate IV, over 24 hours, and IT on days 1, 11, 21, 31, and 41, patients \>21.5 years old receive pegaspargase IV, over 1 to 2 hours, and patients \< 21.5 years old receive calaspargase pegol IV, over 1 hour on days 2 and 22. CD20+ patients receive rituximab IV on days 1 and 11. COURSE IV (DELAYED INTENSIFICATION): Patients receive vincristine sulfate IV, over 1 to 10 minutes, on days 1, 8, 15, 43, and 50, dexamethasone PO or IV BID on days 1-7 and 15-21, doxorubicin IV, over 3 to 60 minutes, on days 1, 8, and 15, patients \>21.5 years old receive pegaspargase IV, over 1 to 2 hours, on day 4, 5, or 6 and day 43, patients \<21.5 years old receive calaspargase pegol IV, over 1 hour, on days 2 and 22. Patients also receive cyclophosphamide IV on day 29, cytarabine IV or SC on days 29-32 and 36-39, thioguanine PO on days 29-42 and methotrexate IT on days 1, 29, and 36. CD20+ patients receive rituximab IV on days 1 and 8. Patients then undergo bone marrow aspirate and biopsy one week after completion of course IV. COURSE V (MAINTENANCE THERAPY): Patients receive vincristine sulfate IV, over 1 to 10 minutes, on days 1, 29, and 57, dexamethasone PO or IV BID on days 1-5, 29-33, and 57-61, and mercaptopurine PO on days 1-84. Patients also receive methotrexate IT or PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78. Treatment repeats every 12 weeks for up to 3 years in the absence of disease progression or unacceptable toxicity. Patients undergo multigated acquisition scan (MUGA) or echocardiography and x ray imaging during screening, bone marrow aspiration and biopsy and lumbar puncture and blood sample collection throughout the study. ARM II (CLOSED 7/23/2025): Patients receive inotuzumab ozogamicin IV, over 1 hour, on days 1, 8, and 15 and undergo bone marrow aspirate and biopsy on day 28. Treatment repeats every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. Patients who are MRD+ and CD19+ after completion of 2 cycles of inotuzumab ozogamicin receive dexamethasone IV or PO on day 1 and blinatumomab IV via continuous infusion on days 1-28, followed by a 14 day break. Cycles repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive remission consolidated chemotherapy, interim maintenance chemotherapy, delayed intensification, and maintenance therapy as in Arm I. Patients undergo MUGA or echocardiography and x ray imaging during screening, bone marrow aspiration and biopsy and lumbar puncture and blood sample collection throughout the study. PILOT COHORT: Patients receive inotuzumab ozogamicin IV, over 1 hour, on days 1, 8, and 15 and undergo bone marrow aspirate and biopsy on day 28. COURSE II (REMISSION CONSOLIDATION CHEMOTHERAPY): Patients receive cyclophosphamide IV on days 1 and 29, cytarabine IV or SC on days 1-4, 8-11, 29-32, and 36-39, mercaptopurine PO on days 1-14 and 29-42, and vincristine sulfate IV, over 1 to 10 minutes, on days 15, 22, 43, and 50. Patients \> 21.5 years old also receive pegaspargase IV, over 1 to 2 hours, on days 15 and 43 and patients \< 21.5 years old receive calaspargase pegol IV, over 1 hour, on days 15 and 43, and methotrexate IT on days 1, 8, 15, and 22. Patients with CNS3 receive methotrexate IT only on days 1 and 8. CD20+ patients receive rituximab IV on days 1, 8, 29, and 36. Patients with evidence of testicular disease at diagnosis also receive RT. Patients then undergo bone marrow aspirate and biopsy on day 56. BLINATUMOMAB: Patients receive blinatumomab IV, continuously, on days 1-28 of one 42-day cycle in the absence of disease progression or unacceptable toxicity. Patients also receive dexamethasone PO or IV prior to starting the blinatumomab cycle, and a single dose of methotrexate IT between cycle days 29 and 42. COURSE III (INTERIM MAINTENANCE CHEMOTHERAPY): Patients receive vincristine sulfate IV, over 1 to 10 minutes, on days 1, 11, 21, 31, and 41, methotrexate IV, over 24 hours, and IT on days 1, 11, 21, 31, and 41, patients \>21.5 years old receive pegaspargase IV, over 1 to 2 hours, and patients \< 21.5 years old receive calaspargase pegol IV, over 1 hour on days 2 and 22. CD20+ patients receive rituximab IV on days 1 and 11. BLINATUMOMAB: Patients receive blinatumomab IV, continuously, on days 1-28 of one 42-day cycle in the absence of disease progression or unacceptable toxicity. Patients also receive dexamethasone PO or IV prior to starting the blinatumomab cycle, and a single dose of methotrexate IT between cycle days 29 and 42. Patients who are MRD positive and CD19+ after Course II may continue to receive blinatumomab IV, continuously on days 1-28 of each cycle. Cycles repeat every 42 days for an additional 2 cycles in the absence of disease progression or unacceptable toxicity, per investigator discretion. COURSE IV (DELAYED INTENSIFICATION): Patients receive vincristine sulfate IV, over 1 to 10 minutes on days 1, 8, 15, 43, and 50, dexamethasone PO or IV BID on days 1-7 and 15-21, doxorubicin IV, over 3 to 60 minutes, on days 1, 8, and 15, patients \> 21.5 years old receive pegaspargase IV, over 1 to 2 hours, on day 4, 5, or 6 and day 43, patients \< 21.5 years old receive calaspargase pegol IV, over 1 hour, on day 4, 5, or 6 and 43. Patients also receive cyclophosphamide IV on day 29, cytarabine IV or SC on days 29-32 and 36-39, thioguanine PO on days 29-42 and methotrexate IT on days 1, 29, and 36. CD20+ patients receive rituximab IV on days 1 and 8. Patients then undergo bone marrow aspirate and biopsy one week after completion of course IV. COURSE V (MAINTENANCE THERAPY): Patients receive vincristine sulfate IV, over 1 to 10 minutes on days 1, 29, and 57, dexamethasone PO or IV BID on days 1-5, 29-33, and 57-61, and mercaptopurine PO on days 1-84. Patients also receive methotrexate IT on day 1 of cycles 1-4 and PO once weekly (QW) of each cycle. Treatment repeats every 12 weeks for up to 3 years in the absence of disease progression or unacceptable toxicity. Patients undergo MUGA or echocardiography and x ray imaging during screening, bone marrow aspiration and biopsy and lumbar puncture and blood sample collection throughout the study. After completion of study treatment, patients are followed up every 2 months for 2 years, every 3 months 2 years, and then every 6 months for up to 10 years.

Patologie

B Acute Lymphoblastic Leukemia

Idoneità

Idoneità
Sesso	Tutti
Età	18 Years – 39 Years
Volontari sani	No

Idoneità come riportata nel registro

Inclusion Criteria: REGISTRATION ELIGIBILITY CRITERIA (STEP 1) * Newly diagnosed patients with CD-22 positive B-cell acute lymphoblastic leukemia (WHO criteria) are eligible. Patients with Burkitt type ALL are NOT eligible * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Single-dose intrathecal cytarabine is allowed prior to registration or prior to initiation of systematic therapy for patient convenience; this is usually done at the time of the diagnostic bone marrow or venous line placement to avoid a second lumbar puncture; systemic chemotherapy must begin within 72 hours of this intrathecal therapy * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Age \>= 18 years and \< 40 years * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Aspartate aminotransferase (AST), alanine aminotransferase (ALT) =\< 3 x upper limit of normal (ULN), unless suspected leukemic involvement of the liver * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Direct bilirubin =\< 3 x upper limit of normal (ULN), unless suspected leukemic involvement of the liver * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Calculated (calc.) creatinine clearance \>= 50 mL/min by Cockcroft-Gault * RANDOMIZATION ELIGIBILITY CRITERIA (STEP 2) CONFIRMATION OF TOLERABILITY AND PHASE III ONLY): Completion of remission induction therapy * RANDOMIZATION ELIGIBILITY CRITERIA (STEP 2) CONFIRMATION OF TOLERABILITY AND PHASE III ONLY):Patients with M2 marrow or better are eligible; patients with M3 or M4 marrow (greater than 25% lymphoblasts) will not be eligible to be randomized * Rating: M0, M1; Blast Cells (%): 0-5.0 * Rating: M2; Blast Cells (%): 5.1-25.0 * Rating: M3; Blast Cells (%): \> 25-50 * Rating: M4; Blast Cells (%): \> 50.0 * The term "blast cell" includes any cell that cannot be classified as a more mature normal element, and includes "leukemic cells," pathologic lymphocytes, and stem cells * RANDOMIZATION ELIGIBILITY CRITERIA (STEP 2) (CONFIRMATION OF TOLERABILITY AND PHASE III ONLY): Absolute neutrophil count (ANC) \>= 750/mm\^3 * RANDOMIZATION ELIGIBILITY CRITERIA (STEP 2) (CONFIRMATION OF TOLERABILITY AND PHASE III ONLY): Platelet count \>= 75,000/mm\^3 * RANDOMIZATION ELIGIBILITY CRITERIA (STEP 2) (CONFIRMATION OF TOLERABILITY AND PHASE III ONLY): Total bilirubin =\< 1.5 x upper limit of normal (ULN), except for patients with known Gilbert's syndrome * RANDOMIZATION ELIGIBILITY CRITERIA (STEP 2) (CONFIRMATION OF TOLERABILITY AND PHASE III ONLY): Aspartate aminotransferase (AST) =\< 8 x upper limit of normal (ULN) EXCLUSION CRITERIA * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients who have BCR-ABL fusion transcript determined by fluorescence in situ hybridization (FISH) or real time-polymerase chain reaction (RT-PCR) or t(9;22)(q34;q11) by cytogenetics are not eligible and should be considered for enrollment on studies that incorporate imatinib during induction; please note: patients must also be assessed for CD20 positivity and other markers; positivity for CD22 and CD20 is defined as baseline expression of the CD22 or CD20 antigen in more than 20% of leukemic cells using local multiparameter flow-cytometric immunophenotyping with the use of CD45 expression as a marker to gate the ALL blast population, according to recommendations from the European LeukemiaNet * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): No prior therapy for ALL except for limited treatment (=\< 7 days) with corticosteroids or hydroxyurea and a single dose of intrathecal cytarabine; however, patients who are being treated with chronic steroids for other reasons (for example, to treat asthma, autoimmune disorders, lupus, etc.) are eligible * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): No prior therapy for acute leukemia except emergency therapy (corticosteroids or hydroxyurea) for blast cell crisis, superior vena cava syndrome, or renal failure due to leukemic infiltration of the kidneys; when indicated, leukapheresis or exchange transfusion is recommended to reduce the WBC * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Not pregnant and not nursing, because this study involves agents that have known genotoxic, mutagenic and teratogenic effects; therefore, for women of childbearing potential only, a negative urine or serum pregnancy test done =\< 8 days prior to registration is required * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients with down syndrome are excluded from this study due to the likelihood of excessive toxicity resulting; these patients should be treated in consultation with a pediatric oncologist

Idoneità in frasi semplici

I criteri di questa scheda non sono ancora stati suddivisi in affermazioni distinte. Il testo del registro qui sopra è completo ed è la versione autorevole.

Disegno dello studio

Disegno dello studio
Tipo di studio	Interventistico
Fase	Fase 3
Assegnazione	Randomizzata
Modello di intervento	PARALLEL
Finalità principale	TREATMENT
Mascheramento	NONE (0)
Arruolamento	303 partecipanti ricercati

Sponsor e collaboratori

Alliance for Clinical Trials in Oncology Sponsor
National Cancer Institute (NCI) Collaboratori

Bracci e interventi

Arm I (frontline chemotherapy)ACTIVE_COMPARATOR
See detailed description.
Arm II (frontline chemotherapy, inotuzumab ozogamicin)EXPERIMENTAL
Patients receive inotuzumab ozogamicin IV on days 1, 8, and 15 and undergo bone marrow aspirate and biopsy on day 28. Treatment repeats every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. Patients who are MRD+ and CD19+ after completion of 2 cycles of inotuzumab ozogamicin receive dexamethasone IV or PO on day 1 and blinatumomab IV via continuous infusion on days 1-28, followed by a 14 day break. Cycles repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive remission consolidated chemotherapy, interim maintenance chemotherapy, delayed intensification, and maintenance therapy as in Arm I. Patients undergo MUGA or echocardiography and x ray imaging during screening, bone marrow aspiration and biopsy and lumbar puncture and blood sample collection throughout the study.

Interventi

Farmaco Allopurinol
Given PO
Procedura Bone Marrow Aspiration and Biopsy
Undergo bone marrow aspiration and biopsy
Farmaco Cyclophosphamide
Given IV
Farmaco Cytarabine
Given IT, IV, SC
Farmaco Daunorubicin Hydrochloride
Given IV
Farmaco Dexamethasone
Given PO or IV
Farmaco Doxorubicin
Given IV
Biologico Inotuzumab Ozogamicin
Given IV
Altro Laboratory Biomarker Analysis
Correlative studies
Farmaco Mercaptopurine
Given PO
Farmaco Methotrexate
Given IT, IV, PO
Farmaco Pegylated L-Asparaginase
Given IV
Biologico Rituximab
Given IV
Farmaco Thioguanine
Given PO
Farmaco Vincristine Sulfate
Given IV

Esiti misurati

Esito primario
Event-free survival (EFS)
The EFS distributions between the two arms will be compared using non-stratified log-rank tests. EFS curves will be constructed using the Kaplan-Meier product limit method, and additional analyses will be done using the Cox proportional hazards model. with diagnostics test on proportional hazard assumptions first. The corresponding hazard ratio, 2- and 3-year EFS estimates will be assessed, and EFS medians along with their 95% confidence intervals for the two treatment arms.
Orizzonte temporale Time from induction response to the time of progressive-disease, secondary malignancy, or death, assessed up to 3 years
Esito secondario
Disease-free survival (DFS)
Orizzonte temporale Time from achievement of complete response (CR) to the time of relapse and/or death, assessed up to 10 years
Esito secondario
Overall Survival (OS)
Will be evaluated using Kaplan-Meier as well as Cox regression models.
Orizzonte temporale Time from randomization to the time of death due to any cause, assessed up to 10 years
Esito secondario
Proportion of patients who achieve CR or any response to induction therapy
Will be summarized as the proportion of patients who achieve any type of response to induction therapy divided by the number of all evaluable patients registered to this trial and who received at least one dose of induction therapy. Corresponding 95% binomial confidence intervals will also be calculated.
Orizzonte temporale Up to 10 years
Esito secondario
Overall induction response rates
Will be summarized as the proportion of patients who achieve any type of response to induction therapy divided by the number of all evaluable patients registered to this trial and who received at least one dose of induction therapy. Corresponding 95% binomial confidence intervals will also be calculated.
Orizzonte temporale Up to 10 years
Esito secondario
Incidence of adverse events as assessed by Common Terminology Criteria for Adverse Events version 5.0
The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns. In addition, all adverse event data that is graded as 3, 4, or 5 will be reviewed and classified as either "unrelated" or "unlikely to be related" to study treatment in the event of an actual relationship developing. The incidence of severe (grade 3+) adverse events or toxicities will be described for each treatment arm, but will also be compared between the arms. Fisher's exact tests will be used to quantitatively compare the incidence of severe as well as specific toxicities of interest between the treatment arms and we will graphically assess differences in maximum grades observed for toxicities between the arms. Tolerability of the treatment arms will be assessed through assessing the number of patients who required dose modifications and/or dose delays.
Orizzonte temporale Up to 10 years
Esito secondario
Proportion of patients who go off treatment due to adverse reactions
Will be assessed within each of the treatment arms and differences explores in these measures between the arms.
Orizzonte temporale Up to 10 years
Esito secondario
Proportion of patients who refuse further treatment for lesser toxicities that inhibit their willingness to continue participation on the trial
Will be assessed within each of the treatment arms and differences explores in these measures between the arms.
Orizzonte temporale Up to 10 years

Date

Date
Data di inizio	20 settembre 2017 (effettiva)
Conclusione primaria	1 marzo 2027 (stimata)
Conclusione	1 agosto 2027 (stimata)
Prima pubblicazione	12 maggio 2017 (effettiva)
Ultimo aggiornamento	2 settembre 2026
Risultati pubblicati	Non indicato nella scheda del registro
Stato verificato l'ultima volta	settembre 2026

«Effettiva» significa che l'evento è avvenuto. «Stimata» significa che lo sponsor lo prevede. Le due cose non sono equivalenti.

Centri

159 centri stanno reclutando

Canada

Canada
Struttura	Città	Stato o regione	Stato
Arthur J E Child Comprehensive Cancer Centre	Calgary	Alberta	Sospeso
QEII Health Sciences Centre/Nova Scotia Health Authority	Halifax	Nova Scotia	Sospeso
Jewish General Hospital	Montreal	Quebec	Sospeso
Ottawa Hospital and Cancer Center-General Campus	Ottawa	Ontario	In reclutamento
CancerCare Manitoba	Winnipeg	Manitoba	Sospeso

United States

United States
Struttura	Città	Stato o regione	Stato
Providence Regional Cancer System-Aberdeen	Aberdeen	Washington	Sospeso
Riverwood Healthcare Center	Aitkin	Minnesota	Sospeso
University of New Mexico Cancer Center	Albuquerque	New Mexico	Attivo, non in reclutamento
Lehigh Valley Hospital-Cedar Crest	Allentown	Pennsylvania	In reclutamento
OSF Saint Anthony's Health Center	Alton	Illinois	Sospeso
American Fork Hospital / Huntsman Intermountain Cancer Center	American Fork	Utah	Sospeso
Community Hospital of Anaconda	Anaconda	Montana	In reclutamento
Anchorage Oncology Centre	Anchorage	Alaska	Sospeso
Alaska Breast Care and Surgery LLC	Anchorage	Alaska	Sospeso
Alaska Oncology and Hematology LLC	Anchorage	Alaska	Sospeso
Alaska Women's Cancer Care	Anchorage	Alaska	Sospeso
Katmai Oncology Group	Anchorage	Alaska	Sospeso
Providence Alaska Medical Center	Anchorage	Alaska	Sospeso
Anchorage Radiation Therapy Center	Anchorage	Alaska	Sospeso
Anchorage Associates in Radiation Medicine	Anchorage	Alaska	Sospeso
Trinity Health Saint Joseph Mercy Hospital Ann Arbor	Ann Arbor	Michigan	In reclutamento
Kaiser Permanente-Deer Valley Medical Center	Antioch	California	In reclutamento
PCR Oncology	Arroyo Grande	California	Sospeso
Northwest Wisconsin Cancer Center	Ashland	Wisconsin	Sospeso
Duluth Clinic Ashland	Ashland	Wisconsin	Sospeso
Emory University Hospital/Winship Cancer Institute	Atlanta	Georgia	In reclutamento
Augusta University Medical Center	Augusta	Georgia	In reclutamento
The Medical Center of Aurora	Aurora	Colorado	Sospeso
Rocky Mountain Cancer Centers-Aurora	Aurora	Colorado	Attivo, non in reclutamento
Saint Alphonsus Cancer Care Center-Baker City	Baker City	Oregon	Sospeso
Mercy Oncology and Hematology - Clayton-Clarkson	Ballwin	Missouri	Sospeso
University of Maryland/Greenebaum Cancer Center	Baltimore	Maryland	In reclutamento
Medical Center of Baton Rouge	Baton Rouge	Louisiana	Attivo, non in reclutamento
Ochsner Health Center-Summa	Baton Rouge	Louisiana	Attivo, non in reclutamento
Ochsner High Grove	Baton Rouge	Louisiana	Attivo, non in reclutamento
Bronson Battle Creek	Battle Creek	Michigan	Sospeso
Nebraska Medicine-Bellevue	Bellevue	Nebraska	In reclutamento
Overlake Medical Center	Bellevue	Washington	Sospeso
PeaceHealth Saint Joseph Medical Center	Bellingham	Washington	Sospeso
Saint Charles Health System	Bend	Oregon	Sospeso
Lehigh Valley Hospital - Muhlenberg	Bethlehem	Pennsylvania	In reclutamento
Billings Clinic Cancer Center	Billings	Montana	In reclutamento
Saint Vincent Healthcare	Billings	Montana	Sospeso
Saint Vincent Frontier Cancer Center	Billings	Montana	Sospeso
University of Alabama at Birmingham Cancer Center	Birmingham	Alabama	Attivo, non in reclutamento
Prisma Health Cancer Institute - Spartanburg	Boiling Springs	South Carolina	In reclutamento
Saint Alphonsus Cancer Care Center-Boise	Boise	Idaho	In reclutamento
Saint Luke's Cancer Institute - Boise	Boise	Idaho	In reclutamento
Central Care Cancer Center - Bolivar	Bolivar	Missouri	Sospeso
Massachusetts General Hospital Cancer Center	Boston	Massachusetts	In reclutamento

Nella scheda del registro sono indicati altri 410 centri.

Documenti dello studio

In questa scheda del registro non sono collegati documenti.

Modifiche nel tempo

Non è stata registrata alcuna modifica da quando abbiamo acquisito questa scheda.

Viene registrata una modifica ogni volta che lo sponsor aggiorna la scheda del registro. Stato, date, arruolamento e centri compaiono qui man mano che cambiano.

Registro: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT03150693