NCT07321652ClinicalTrials.gov
Testing the Addition of Anti-Cancer Drug Sonrotoclax, to the Standard Treatment Zanubrutinib, for Previously Untreated CLL/SLL
Phase III Evaluation of Fixed Duration Zanubrutinib Plus Sonrotoclax-Based Therapy Compared to Continuous Zanubrutinib in Previously Untreated Older Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)
En resumen
This phase III trial compares the effect of adding sonrotoclax to zanubrutinib versus zanubrutinib alone for the treatment of patients with untreated chronic lymphoblastic leukemia (CLL)/small lymphocytic lymphoma (SLL). Sonrotoclax is in a class of medications called B-cell lymphoma-2 (BCL-2)…
Fase 3466 participantes buscados210 centros1 país
Categorías
Registrado en 1 registro
- ClinicalTrials.govNCT07321652Abrir este registro en ClinicalTrials.govSincronizado hace 3 semanas
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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 2026-01-07; recorded start 2026-04-30
- 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 2 conditions.
- Lead sponsor type recorded as: other.
- Intervention regulatory context: investigational, within a phased regulatory pathway.
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.
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: 152 sites
- Data monitoring committee0/7
No data monitoring committee stated
- Prospective registration5/5
Registered before the study start date
- Protocol / SAP posted0/5
No protocol or SAP posted to the registry
A medium-sized study: 466 participants (target), run at 210 sites.
How this score is built
- Enrolment26/40
466 participants (target)
- Site count24/25
152 sites
- Country count0/15
Single country
- Planned duration10/10
Planned over about 151 months
- Sponsor scale7/10
Alliance for Clinical Trials in Oncology has led 96 trials in our corpus
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.
Resumen
This phase III trial compares the effect of adding sonrotoclax to zanubrutinib versus zanubrutinib alone for the treatment of patients with untreated chronic lymphoblastic leukemia (CLL)/small lymphocytic lymphoma (SLL). Sonrotoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Zanubrutinib is in a class of medications called kinase inhibitors. It blocks a protein called BTK, which is present on B-cell (a type of white blood cells) cancers such as mantel cell lymphoma at abnormal levels. This may help keep cancer cells from growing and spreading. Giving sonrotoclax and zanubrutinib may be more effective than zanubrutinib alone for the treatment of untreated CLL/SLL.
Afecciones
- Chronic Lymphocytic Leukemia
- Small Lymphocytic Leukemia
Elegibilidad
| Sexo | Todos |
|---|---|
| Edades | 65 Years – Sin máximo |
| Voluntarios sanos | No |
Elegibilidad tal como figura en el registro
Elegibilidad en frases sencillas
Los criterios de este registro aún no se han desglosado en frases separadas. El texto del registro anterior está completo y es la versión autorizada.
Diseño del estudio
| Tipo de estudio | De intervención |
|---|---|
| Fase | Fase 3 |
| Asignación | Aleatorizado |
| Modelo de intervención | PARALLEL |
| Propósito principal | TREATMENT |
| Enmascaramiento | NONE (0) |
| Inscripción | 466 participantes buscados |
Patrocinador y colaboradores
- Alliance for Clinical Trials in Oncology Patrocinador
- National Cancer Institute (NCI) Colaboradores
Grupos e intervenciones
- Arm 1 (zanubrutinib)ACTIVE_COMPARATOR
Patients receive zanubrutinib PO BID on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo restaging starting at cycle 15 day 1. Patients with at least partial remission continue therapy as described above. Patients with progressive disease proceed to follow up. Patients undergo CT scan, bone marrow aspiration and blood sample collection throughout the study.
- Arm 2 (zanubrutinib and sonrotoclax)EXPERIMENTAL
Patients receive zanubrutinib PO BID on days 1-28 of each cycle. Starting cycle 4 day 1 patients also receive sonrotoclax PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo restaging starting at cycle 15 day 1. Patients with undetectable MRD and a response of PR, PR-L, CR, CCR or CRi stop therapy at cycle 15 day 28 and proceed to follow up. Patients with detectable MRD and an objective response to therapy are re-randomized to arm 2B or arm 2C. ARM 2B: Patients continue zanubrutinib PO BID sonrotoclax PO QD on days 1-28 of each cycle. Cycles repeat every 28 days for an additonal 12 cycles in the absence of disease progression or unacceptable toxicity. ARM 2C: Patients discontinue therapy starting at cycle 15 day 28 and proceed to follow up. Patients undergo CT scan, bone marrow aspiration and blood sample collection
Intervenciones
- Procedimiento Biospecimen Collection
Undergo blood sample collection
- Procedimiento Bone Marrow Aspiration
Undergo bone marrow aspiration
- Procedimiento Computed Tomography
Undergo CT scan
- Fármaco Sonrotoclax
Given PO
- Otro Survey Administration
Ancillary studies
- Fármaco Zanubrutinib
Given PO
Variables de resultado
Variable de resultado principal
Progression free survival (PFS)
From initial randomization date until the earlier of disease progression or death from any cause. PFS estimates for zanubrutinib plus sonrotoclax therapy to continuous Zanubrutinib.
Plazo From initial randomization date until the earlier of disease progression or death from any cause, up to 10 years
Otra variable de resultado
PFS for patients with MRD detectable disease treated with fixed duration zanubrutinib sonrotoclax versus patients with MRD detectable disease who receive one additional year of combination therapy
Undetectable (u) MRD will be defined as \< 10 in 1,000,000 (less than 1 in 10\^-5 \[uMRD5\]) on peripheral blood, and the depth of response below that level, (i.e. down to 10\^-6 \[uMRD6\]), will also be collected. Kaplan-Meier will be used to estimate survival curves, log-rank tests to compare between survival curves, and hazard ration (HRs) and associated 95% CIs will be reported.
Plazo up to 10 years
Otra variable de resultado
Overall survival
OS will be summarized using Kaplan-Meier methodology, with hazard ratios from a stratified Cox proportional hazards model and log-rank test results provided.
Plazo Up to 10 years
Otra variable de resultado
Percentage of patients with MRD detectable disease who convert to uMRD after receiving an extra year of combination therapy on the MRD-guided Zanubrutinib sonrotoclax therapy arm
Proportions of number of MRD+ to uMRD conversion by total number of evaluable patients will be estimated with their corresponding 95% CIs.
Plazo Up to 10 years
Otra variable de resultado
Overall response rate among treatment arms
Overall response rate is defined as the highest response achieved during the first 15 cycles of treatment. A response is defined as a patients achieving PR+.
Plazo Up to 10 years
Otra variable de resultado
Time to next CLL/SLL therapy
Kaplan-Meier estimates and 95% CIs of TTNT. Time is measured as the time from the end of initial treatment to the initiation of subsequent treatment.
Plazo Up to 10 years
Otra variable de resultado
Adverse Event Rates and Severity
Frequency and severity of adverse events and tolerability for each embedded treatment regimen will be collected and summarized using descriptive statistics.
Plazo Up to 10 years
Otra variable de resultado
Patient-reported symptomatic adverse events
As assessed by the Patient Reported Outcome-Common Terminology Criteria for Adverse Events, the frequency and proportion of patients with a maximum baseline-adjusted composite score greater than 0 will be compared between arms using Fisher's exact test. Similarly, the frequency and proportion of patients with a maximum baseline-adjusted composite score greater than or equal to 3 will be compared between arms using Fisher's exact test.
Plazo Up to 10 years
Fechas
| Fecha de inicio | 30 de abril de 2026 (real) |
|---|---|
| Finalización principal | 30 de septiembre de 2028 (estimada) |
| Finalización | 30 de septiembre de 2038 (estimada) |
| Primera publicación | 7 de enero de 2026 (real) |
| Última actualización | 2 de septiembre de 2026 |
| Resultados publicados | No indicado en el registro |
| Estado verificado por última vez | septiembre de 2026 |
Real significa que el evento ocurrió. Estimada significa que el patrocinador lo prevé. Ambas cosas significan algo distinto.
Ubicaciones
206 centros están en reclutamiento
United States
| Centro | Ciudad | Estado o región | Estado |
|---|---|---|---|
| Avera Cancer Institute-Aberdeen | Aberdeen | South Dakota | En reclutamiento |
| Hendrick Medical Center | Abilene | Texas | En reclutamiento |
| Mary Greeley Medical Center | Ames | Iowa | En reclutamiento |
| McFarland Clinic - Ames | Ames | Iowa | En reclutamiento |
| Community Hospital of Anaconda | Anaconda | Montana | En reclutamiento |
| Kaiser Permanente-Anaheim | Anaheim | California | En reclutamiento |
| UI Health Care Mission Cancer and Blood - Ankeny Clinic | Ankeny | Iowa | En reclutamiento |
| Duluth Clinic Ashland | Ashland | Wisconsin | En reclutamiento |
| OhioHealth O'Bleness Hospital | Athens | Ohio | En reclutamiento |
| Saint Alphonsus Cancer Care Center-Baker City | Baker City | Oregon | En reclutamiento |
| Kaiser Permanente-Baldwin Park | Baldwin Park | California | En reclutamiento |
| Kaiser Permanente-Bellflower | Bellflower | California | En reclutamiento |
| Sanford Joe Lueken Cancer Center | Bemidji | Minnesota | En reclutamiento |
| Billings Clinic Cancer Center | Billings | Montana | En reclutamiento |
| University of Alabama at Birmingham Cancer Center | Birmingham | Alabama | En reclutamiento |
| Sanford Bismarck Medical Center | Bismarck | North Dakota | En reclutamiento |
| Illinois CancerCare-Bloomington | Bloomington | Illinois | En reclutamiento |
| Saint Alphonsus Cancer Care Center-Boise | Boise | Idaho | En reclutamiento |
| Dana-Farber Cancer Institute | Boston | Massachusetts | En reclutamiento |
| Bozeman Health Deaconess Hospital | Bozeman | Montana | En reclutamiento |
| Essentia Health Saint Joseph's Medical Center | Brainerd | Minnesota | En reclutamiento |
| Trinity Health IHA Medical Group Hematology Oncology - Brighton | Brighton | Michigan | En reclutamiento |
| Saint Alphonsus Cancer Care Center-Caldwell | Caldwell | Idaho | En reclutamiento |
| Trinity Health IHA Medical Group Hematology Oncology - Canton | Canton | Michigan | En reclutamiento |
| Illinois CancerCare-Canton | Canton | Illinois | En reclutamiento |
| Saint Francis Medical Center | Cape Girardeau | Missouri | En reclutamiento |
| Saint Anthony Regional Hospital | Carroll | Iowa | En reclutamiento |
| Illinois CancerCare-Carthage | Carthage | Illinois | En reclutamiento |
| Oncology Associates at Mercy Medical Center | Cedar Rapids | Iowa | En reclutamiento |
| Mercy Hospital | Cedar Rapids | Iowa | En reclutamiento |
| Cancer Center of Kansas - Chanute | Chanute | Kansas | En reclutamiento |
| UNC Lineberger Comprehensive Cancer Center | Chapel Hill | North Carolina | En reclutamiento |
| Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital | Chelsea | Michigan | En reclutamiento |
| Jefferson Cherry Hill Hospital | Cherry Hill | New Jersey | En reclutamiento |
| Northwestern University | Chicago | Illinois | En reclutamiento |
| University of Illinois | Chicago | Illinois | En reclutamiento |
| Siteman Cancer Center at Saint Peters Hospital | City of Saint Peters | Missouri | En reclutamiento |
| UI Health Care Mission Cancer and Blood - West Des Moines Clinic | Clive | Iowa | En reclutamiento |
| Kootenai Health - Coeur d'Alene | Coeur d'Alene | Idaho | En reclutamiento |
| Baptist Memorial Hospital and Cancer Center-Collierville | Collierville | Tennessee | En reclutamiento |
| Grant Medical Center | Columbus | Ohio | En reclutamiento |
| Riverside Methodist Hospital | Columbus | Ohio | En reclutamiento |
| Columbus Oncology and Hematology Associates Inc | Columbus | Ohio | En reclutamiento |
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | En reclutamiento |
| Doctors Hospital | Columbus | Ohio | En reclutamiento |
| Mercy Hospital | Coon Rapids | Minnesota | En reclutamiento |
| UM Sylvester Comprehensive Cancer Center at Coral Gables | Coral Gables | Florida | En reclutamiento |
| UM Sylvester Comprehensive Cancer Center at Coral Springs | Coral Springs | Florida | En reclutamiento |
| Siteman Cancer Center at West County Hospital | Creve Coeur | Missouri | En reclutamiento |
| Carle at The Riverfront | Danville | Illinois | En reclutamiento |
En el registro figuran 160 centros más.
Documentos del estudio
No hay documentos enlazados en este registro.
Cambios a lo largo del tiempo
- 2 de septiembre de 2026
Centro añadido
28 sites added (210 total)
182210
- 5 de agosto de 2026
Centro añadido
30 sites added (182 total)
152182