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AzTrials

Mantle Cell LymphomaPhase 2BRAZANNCT06854003

BRAZAN: A Randomized Phase 2 Study of Bendamustine, Rituximab, Cytarabine (AraC) Induction With Zanubrutinib (BRAZAN) Followed by Zanubrutinib/Rituximab +/- Sonrotoclax Maintenance in Treatment-Naïve Mantle Cell Lymphoma

A Phase 2 study testing Bendamustine, Rituximab and Cytarabine in people with Mantle Cell Lymphoma and Lymphoma, run by Christine Ryan at 7 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study aims to evaluate the efficacy and safety of an induction regimen combining Bendamustine, Rituximab, Cytarabine (AraC), and Zanubrutinib (BRAZAN), followed by maintenance therapy with Zanubrutinib and Rituximab with or without Sonrotoclax in participants with Mantle Cell Lymphoma (MCL). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Mantle Cell Lymphoma, Lymphoma
What is being tested?
Bendamustine, Rituximab and Cytarabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
7 sitesUnited States
Study dates
22 Apr 2025to 1 Nov 2039
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed diagnosis of mantle cell lymphoma, with review of the diagnostic pathology specimen at one of the participating institutions. Whenever possible, the Ki67 fraction should be reported or evaluated, cytogenetics should be performed, and TP53 status should be assessed (preferably by next-generation sequencing; immunohistochemical staining would be next-preferred).
  • No prior anti-lymphoma therapy, with the following exceptions:
  • Prior radiotherapy for localized disease is permitted.
  • A course of radiotherapy for urgent symptomatic disease is also permitted. Short-course systemic corticosteroids is permissible for disease control (must be < 7 days and ≤ 100mg/day of prednisone or ≤ 20mg/day of dexamethasone, or equivalent). Steroids must be discontinued prior to study treatment.
  • Measurable disease, defined as ≥1 measurable nodal lesion (long axis >1.5 cm or short axis >1.0 cm) or ≥1 measurable extra-nodal lesion (long axis >1.0 cm) on PET, CT, or magnetic resonance imaging (MRI). Disease should be FDG-avid based on PET.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. (Appendix A)
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  • Age ≥18 years and considered a candidate for high-dose cytarabine by the treating physician.
  • Adequate hematologic and organ function defined as:
  • Absolute neutrophil count ≥ 1.0 x109/L, or ≥ 0.5 x109/L if bone marrow involvement (use of growth factor support allowed).
  • Hemoglobin ≥ 8 g/dL and independent of transfusion within 7 days of screening.
  • Platelets ≥ 100 x109/L, or ≥ 50 x109/L if bone marrow involvement, and independent of transfusion within 7 days of screening.
  • Estimated CrCl ≥ 30mL/min (by Cockcroft-Gault formula or by 24-hour urine collection).
  • AST/ALT < 2.5 X institutional upper limit of normal (ULN), or < 5.0 X institutional ULN if documented liver involvement of lymphoma.
  • Total bilirubin < 2.0 X ULN (unless active hemolysis); for subjects with Gilbert's Syndrome, direct bilirubin < 1.5 X ULN.
  • Patients with known infection with human immunodeficiency virus (HIV) are eligible, provided all 3 of the following are true: 1) presence of controlled disease, defined as CD4 count ≥ 200/uL and an undetectable viral load, 2) disease control has been stable on anti-retroviral therapy for at least 6 months prior to study enrollment, and 3) there are no prohibitive drug-drug interactions between study drugs and the necessary anti- retroviral therapies.
  • Willingness to provide a pre-treatment tumor sample by core needle or excisional surgical biopsy. A fresh biopsy is strongly encouraged, but an archival sample is acceptable if it is collected within 90 days and without intervening treatment and the following provisions are met: 1) availability of a tumor-containing formalin-fixed, paraffin-embedded (FFPE) tissue block, 2) if the tumor containing FFPE tissue block cannot be provided in total, sections from this block should be provided that are freshly cut and mounted on positively-charged glass slides. Preferably, 25 slides should be provided; if not possible, a minimum of 15 slides is required. Exceptions to this criterion may be made with approval of the Sponsor-Investigator.
  • Willingness to remain abstinent or to use two effective contraceptive methods that result in a failure rate of <1% per year from screening until at least:
  • 6 months after the last dose of bendamustine,
  • 6 months after the last dose of cytarabine,
  • 90 days after the last dose of zanubrutinib,
  • 90 days after the last dose of sonrotoclax, and/or
  • 12 months after the last dose of rituximab, whichever of the above is longest. Examples of contraceptive methods with a failure rate of <1% per year include:
  • Tubal ligation, male sterilization, hormonal implants, established proper use of hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices.
  • Alternatively, two methods (e.g., two barrier methods such as a condom and a cervical cap) may be combined to achieve a failure rate of <1% per year. Barrier methods must always be supplemented with the use of a spermicide.
  • True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject. In contrast, periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
  • Ability to understand and the willingness to sign a written informed consent document.

Who cannot join

  • Known central nervous system involvement.
  • Known active infection requiring systemic antimicrobial therapy at trial enrollment.
  • Patients, who have had a major surgery or significant traumatic injury within 4 weeks of start of study drug, patients who have not recovered from the side effects of any major surgery (defined as requiring general anesthesia).
  • Participants who require warfarin or other vitamin K antagonists for anticoagulation. Other anticoagulants including direct oral anticoagulants (i.e. apixaban, rivaroxaban) and low-molecular weight heparin are allowed.
  • History of severe bleeding disorder such as hemophilia A, hemophilia B, von Willebrand disease, or history of spontaneous bleeding requiring blood transfusions or other medical interventions.
  • History of stroke or intracranial hemorrhage within 6 months of first dose of zanubrutinib.
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  • History of significant or life-threatening hemorrhage within 3 months of first dose of zanubrutinib.
  • History of uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia, unless these conditions are related to the underlying malignancy.
  • Active hepatitis C infection. Patients with presence of HCV antibody are eligible if HCV RNA is undetectable (NOTE: the limit of detection for HCV RNA must have a sensitivity of < 15 IU/mL). Subjects who received treatment for HCV that was intended to eradicate the virus and who have an undetectable HCV RNA may participate without serial HCV RNA screening. Other patients may participate if they are willing to undergo every 3- month monitoring for HCV reactivation.
  • Active hepatitis B infection. Patients with positive hepatitis B serologies with undetectable HBV DNA (NOTE: the limit of detection for HBV DNA must have a sensitivity of < 20 IU/mL) are permitted in the trial but should receive prophylactic antiviral therapy (i.e. entecavir) and undergo every 3 month HBV DNA monitoring.
  • Prior history of another malignancy unless treated with curative intent and disease-free for at least 3 years at time of screening with expected low risk of recurrence during expected timeframe of study participation. Such patients should first be discussed with the Sponsor-Investigator. Additional exceptions: non-melanoma skin cancer, in situ cervical or breast cancer, or Gleason 6 prostate cancer managed with observation.
  • Patients with the following cardiac conditions will be excluded:
  • New York Heart Association Class III or IV heart failure.
  • Myocardial infarction within 6 months of screening.
  • Unstable angina within 3 months prior to screening.
  • Active uncontrolled arrhythmia.
  • History of clinically significant ventricular arrhythmias within 6 months of screening (eg sustained Vtach, Vfib, torsades de pointes).
  • History of Mobitz II second-degree or third-degree heart block without a permanent pacemaker in place.
  • Uncontrolled hypertension as indicated by ≥ 2 consecutive blood pressure measurements showing systolic blood pressure > 170 mm Hg and diastolic blood pressure > 105 mm Hg at screening.
  • Screening 12-lead EKG showing a baseline QTcF (Fridericia's correction) > 480 msec.
  • Unable to swallow capsules or disease significantly affecting gastrointestinal function, such as malabsorption syndrome.
  • Participants receiving any medications or substances that are strong CYP3A inducers.
  • Because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated medical reference. As part of the enrollment/informed consent procedures, the participant will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the participant is considering a new over-the-counter medicine or herbal product.
  • Patients who are pregnant, breast-feeding, or intending to become pregnant during the study.
  • Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study or limit adherence to study requirements.
  • Inability to comply with protocol mandated restrictions.

Trial locations and contacts

7 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Dana-Farber Cancer Institute Clinical Trials contact

877-DF-TRIAL (877-338-7425)

DFCILymphomaResearchNurses@partners.org

Clare Phinney contact

clare_phinney@dfci.harvard.edu

7 sites in 1 country

United States7 sites, 6 recruiting

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

    Michael Leukam, MD, 617-667-9920, mleukam@bidmc.harvard.edu

    Recruiting

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02215

    Active, not recruiting

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

    Dana-Farber Cancer Institute Clinical Trials, 877-DF-TRIAL (877-338-7425), DFCILymphomaResearchNurses@partners.org

    Clare Phinney, clare_phinney@dfci.harvard.edu

    Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

    Anita Kumar, MD, 800-525-2225, kumara2@mskcc.org

    Recruiting

  • Mayo Clinic Arizona

    Phoenix, Arizona, 85054

    Javier L Munoz, MD MBA, 480-515-6296, munoz.javier@mayo.edu

    Not yet recruiting

  • Mayo Clinic

    Rochester, Minnesota, 55905

    Yucai Wang, MD, 507-538-3270, wang.yucai@mayo.edu

    Not yet recruiting

  • Washington University

    St Louis, Missouri, 63110

    Brad Kahl, MD, 314-454-8330, bkahl@wustl.edu

    Recruiting

Other trials in United States

About this study

Official title: A Randomized Phase 2 Study of Bendamustine, Rituximab, Cytarabine (AraC) Induction With Zanubrutinib (BRAZAN) Followed by Zanubrutinib/Rituximab +/- Sonrotoclax Maintenance in Treatment-Naïve Mantle Cell Lymphoma

This study aims to evaluate the efficacy and safety of an induction regimen combining Bendamustine, Rituximab, Cytarabine (AraC), and Zanubrutinib (BRAZAN), followed by maintenance therapy with Zanubrutinib and Rituximab with or without Sonrotoclax in participants with Mantle Cell Lymphoma (MCL).

The names of the study drugs involved in this study are:

  • bendamustine (a type of alkylating agent)
  • rituximab (a type of monoclonal antibody)
  • cytarabine (a type of antineoplastic)
  • zanubrutinib (a type of kinase inhibitor)
  • sonrotoclax (a type of BCL2 inhibitor)
Read the detailed description

This Phase 2, multi-center, randomized study is to evaluate the efficacy and safety of an induction regimen combining Bendamustine, Rituximab, Cytarabine (AraC), and Zanubrutinib (BRAZAN), followed by maintenance therapy with Zanubrutinib and Rituximab with or without Sonrotoclax in participants with MCL. These specific maintenance therapy combinations are investigational and are being evaluated to see if the therapies may lengthen the time before MCL returns after initial therapy.

After completing induction therapy, participants will be randomized into one of two groups: Arm A: zanubrutinib + rituximab or Arm B: zanubrutinib + rituximab + sonrotoclax. Randomization means a participant is placed into a study group by chance.

The U.S. Food and Drug Administration (FDA) has approved bendamustine, cytarabine, rituximab, and zanubrutinib for the treatment of other lymphomas and/or blood cancers.

The FDA has approved rituximab as a treatment option for Mantle Cell Lymphoma (MCL).

The FDA has also approved zanubrutinib for mantle cell lymphoma, but only after trying other therapies first.

The FDA has not approved sonrotoclax as a treatment for Mantle Cell Lymphoma (MCL). However sonrotoclax works similarly to a drug called venetoclax, which is also sometimes used to treat mantle cell lymphoma. The U.S. Food and Drug Administration (FDA) has approved venetoclax for the treatment of other blood cancers.

The research study procedures include screening for eligibility, in-clinic treatment visits, electrocardiograms (ECGs), Positron Emission Tomography (PET) scans, Computerized Tomography CT) scans, blood tests, urine tests, lymph node biopsies, and bone marrow biopsies.

It is expected that about 60 people will take part in this research study.

The induction therapy will be 6 "cycles", or rounds of treatment, which will last for up to a little over 5 months. The maintenance therapy will last for up to 2 years.

  • Induction phase:
  • Bendamustine/Rituximab + Zanubrutinib for 3 cycles
  • Rituximab/Cytarabine for 3 cycles
  • Maintenance phase - either:
  • A) Zanubrutinib + Rituximab, or
  • B) Zanubrutinib + Sonrotoclax + Rituximab

BeiGene, Ltd., a pharmaceutical company, is also supporting this research study by providing the drugs zanubrutinib and sonrotoclax and other funding support.

Being tested
Bendamustine, Rituximab, Cytarabine, Zanubrutinib, Sonrotoclax
Keywords
Mantle Cell Lymphoma, Lymphoma
Medical subject headings
Lymphoma, Mantle-Cell, Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BendamustineDrug

    Also called Bendamustine hydrochloride, C16H21Cl2N3O2 · HCl, Bendeka

    An Alkylating agent, multi-dose vial, via intravenous (into the vein) infusion per institutional standard of care.

  • RituximabDrug

    Also called Riabni, Rituxan, Ruxience, Truxima

    An Anti-CD20 antibody, single-use vials, via intravenous infusion per institutional standard of care.

  • CytarabineDrug

    Also called AraC

    An Antineoplastic, single dose vial via intravenous infusion per institutional standard of care.

  • ZanubrutinibDrug

    Also called Brukinsa, BGB-3111, C27H29N5O3

    A BTK inhibitor, capsule taken orally per protocol.

  • SonrotoclaxDrug

    Also called BGB-11417

    A BCL 2 Protein Inhibitor, immediate release tablet, taken orally per protocol.

Study groups in NCT06854003
Study groupRoleWhat they receive
Induction Therapy (All Patients)ExperimentalEnrolled participants will complete: * Baseline visit with PET/CT, lymph node biopsy, and bone marrow biopsy * Cycles 1 through 3 (28-day cycles): * Days 1 - 28: Predetermined dose of Zanubrutinib 2x daily * Days 1 and 2: Predetermined dose of Bendamustine 1x daily * Day 1: Predetermined dose of Rituximab 1x daily * PET/CT scan * Cycles 4 through 6 (21-day cycles): * Day 1: Predetermined dose of Rituximab 1x daily * Days 1 and 2: Predetermined dose of Cytarabine 2x daily * PET/CT scan Participants without disease progression will proceed to randomization to either Arm A or Arm B for maintenance therapy.
Receives: Drug: Bendamustine; Drug: Rituximab; Drug: Cytarabine; Drug: Zanubrutinib
Maintenance Arm A: Zanubrutinib + RituximabExperimentalFollowing randomization participants with a complete response to induction therapy will complete: * Cycles 1 - 24 (28-day cycles): * Days 1 through 28: Predetermined dose of Zanubrutinib 2x daily * Day 1 every other cycle: Predetermined dose of Rituximab 1x daily * PET/CT on Cycles 7, 12, 19, and at end of treatment * Post-treatment follow up: every 6 months. PET/CT every 12 months
Receives: Drug: Rituximab; Drug: Zanubrutinib
Maintenance Arm B: Zanubrutinib + Rituximab + SonrotoclaxExperimentalFollowing randomization participants with a complete response to induction therapy will complete: * Cycles 1 - 24 (28-day cycles): * Days 1 through 28: Predetermined dose of Zanubrutinib 2x daily * Days 1 through 28: Predetermined dose of Sonrotoclax 1x daily * Day 1 every other cycle: Predetermined dose of Rituximab 1x daily * PET/CT on Cycles 7, 12, 19, and at end of treatment * Post-treatment follow up: every 6 months. PET/CT every 12 months
Receives: Drug: Rituximab; Drug: Zanubrutinib; Drug: Sonrotoclax
Maintenance Arm B with Sonrotoclax Ramp-Up: Zanubrutinib + Rituximab + SonrotoclaxExperimentalFollowing randomization participants with an incomplete response to induction therapy will require a ramp-up initiation of sonrotoclax and will complete: * Cycles 1 - 24 (28-day cycles): * Days 1 through 28: Predetermined dose of Zanubrutinib 2x daily * Days 1 through 28: Predetermined dose of Sonrotoclax 1x daily **Cycles 1 and 2: Predetermined dose of Sonrotoclax 1x daily will be increased weekly. * Day 1 every other cycle: Predetermined dose of Rituximab 1x daily * PET/CT on Cycles 7, 12, 19, and at end of treatment * Post-treatment follow up: every 6 months. PET/CT every 12 months
Receives: Drug: Rituximab; Drug: Zanubrutinib; Drug: Sonrotoclax

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Complete Response Rate (CRR) after 1-year of Maintenance Treatment

    CRR after maintenance treatment is defined as the proportion of participants who experienced complete response (CR) with peripheral blood (PB) MRD-negativity after 1-year of maintenance therapy.

    Measured: Up to 125 weeks

Secondary outcomes (40)

  1. Grade 4 Treatment-Related Toxicity Rate of zanubrutinib in combination with sonrotoclax and rituximab

    The percentage of participants who experienced a maximum grade 4 treatment-related adverse event based on the Common Toxicity Criteria for Adverse events Version 5.0 (CTCAEv5) as reported on case report forms.

    Measured: Up to 125 weeks

  2. Grade 4 Treatment-Related Toxicity Rate of zanubrutinib in combination with BR

    The percentage of participants who experienced a maximum grade 4 treatment-related adverse event based on the Common Toxicity Criteria for Adverse events Version 5.0 (CTCAEv5) as reported on case report forms.

    Measured: Up to 125 weeks

  3. Complete Response Rate (CRR) after Maintenance Treatment in doublet arm

    CRR after maintenance treatment is defined as the proportion of participants who experienced complete response (CR) with PB MRD-negativity after maintenance therapy.

    Measured: Up to 125 weeks

  4. Complete Response Rate (CRR) after Maintenance Treatment in triplet arm

    CRR after maintenance treatment is defined as the proportion of participants who experienced complete response (CR) with PB MRD-negativity after maintenance therapy.

    Measured: Up to 125 weeks

  5. Best Overall Response (BRR)

    The best overall response will be the best response recorded from the start of the treatment until disease progression/recurrence.

    Measured: Up to 125 weeks

  6. Best Complete response (CR) rate

    The best CR rate will be calculated as the proportion of participants who obtained a CR at any point during study treatment.

    Measured: Up to 125 weeks

  7. Overall response rate (ORR) after 3 cycles of zanubrutinib + BR

    ORR is defined as the proportion of participants who experienced complete response (CR) or partial response (PR) after 3 cycles of zanubrutinib + BR

    Measured: Up to 125 weeks

  8. Complete response rate (CRR) after 3 cycles of zanubrutinib + BR

    CRR is defined as the proportion of participants who experienced complete response (CR) after 3 cycles of zanubrutinib + BR

    Measured: Up to 125 weeks

  9. Partial response rate (PRR) after 3 cycles of zanubrutinib + BR

    PRR is defined as the proportion of participants who experienced partial response (PR) after 3 cycles of zanubrutinib + BR

    Measured: Up to 125 weeks

  10. Overall response rate (ORR) after 6 cycles of BRAZAN induction

    ORR is defined as the proportion of participants who experienced complete response (CR) or partial response (PR) after 6 cycles of BRAZAN induction

    Measured: Up to 125 weeks

  11. Complete response rate (CRR) after 6 cycles of BRAZAN induction

    CRR is defined as the proportion of participants who experienced complete response (CR) after 6 cycles of BRAZAN induction

    Measured: Up to 125 weeks

  12. Partial response rate (PRR) after 6 cycles of BRAZAN induction

    PRR is defined as the proportion of participants who experienced partial response (PR) after 6 cycles of BRAZAN induction

    Measured: Up to 125 weeks

  13. Overall response rate (ORR) after the entire treatment course

    ORR is defined as the proportion of participants who experienced complete response (CR) or partial response (PR) after the entire treatment course

    Measured: Up to 125 weeks

  14. Complete response rate (CRR) after the entire treatment course

    CRR is defined as the proportion of participants who experienced complete response (CR) after the entire treatment course

    Measured: Up to 125 weeks

  15. Partial response rate (PRR) after the entire treatment course

    PRR is defined as the proportion of participants who experienced partial response (PR) after the entire treatment course

    Measured: Up to 125 weeks

  16. Overall response rate (ORR) after the entire treatment course in doublet arm

    ORR is defined as the proportion of participants who experienced complete response (CR) or partial response (PR) after the entire treatment course in doublet arm.

    Measured: Up to 125 weeks

  17. Complete response rate (CRR) after the entire treatment course in doublet arm

    CRR is defined as the proportion of participants who experienced complete response (CR) after the entire treatment course in doublet arm.

    Measured: Up to 125 weeks

  18. Partial response rate (PRR) after the entire treatment course in doublet arm

    PRR is defined as the proportion of participants who experienced partial response (PR) after the entire treatment course in doublet arm.

    Measured: Up to 125 weeks

  19. Overall response rate (ORR) after the entire treatment course in triplet arm

    ORR is defined as the proportion of participants who experienced complete response (CR) or partial response (PR) after the entire treatment course in triplet arm.

    Measured: Up to 125 weeks

  20. Complete response rate (CRR) after the entire treatment course in triplet arm

    CRR is defined as the proportion of participants who experienced complete response (CR) after the entire treatment course in triplet arm.

    Measured: Up to 125 weeks

  21. Partial response rate (PRR) after the entire treatment course in triplet arm

    PRR is defined as the proportion of participants who experienced partial response (PR) after the entire treatment course in triplet arm.

    Measured: Up to 125 weeks

  22. Duration of response (DOR)

    The duration of response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, or death due to any cause. Participants without events reported are censored at the last disease evaluation.

    Measured: Up to 10 years

  23. Duration of complete response (DOCR)

    The duration of CR is measured from the time measurement criteria are first met for CR until the first date that progressive disease is objectively documented, or death due to any cause. Participants without events reported are censored at the last disease evaluation.

    Measured: Up to 10 years

  24. Duration of response (DOR) in doublet arm

    The duration of response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, or death due to any cause. Participants without events reported are censored at the last disease evaluation.

    Measured: Up to 10 years

  25. Duration of complete response (DOCR) in doublet arm

    The duration of CR is measured from the time measurement criteria are first met for CR until the first date that progressive disease is objectively documented, or death due to any cause. Participants without events reported are censored at the last disease evaluation.

    Measured: Up to 10 years

  26. Duration of response (DOR) in triplet arm

    The duration of response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, or death due to any cause. Participants without events reported are censored at the last disease evaluation.

    Measured: Up to 10 years

  27. Median Duration of complete response (DOCR) in triplet arm

    The duration of CR is measured from the time measurement criteria are first met for CR until the first date that progressive disease is objectively documented, or death due to any cause. Participants without events reported are censored at the last disease evaluation.

    Measured: Up to 10 years

  28. Progression free survival (PFS)

    Progression-Free Survival is defined as the time from treatment start to the earlier of progression or death due to any cause. Participants alive without disease progression are censored at date of last disease evaluation.

    Measured: Up to 10 years

  29. Progression free survival (PFS) in doublet arm

    Progression-Free Survival is defined as the time from treatment start to the earlier of progression or death due to any cause. Participants alive without disease progression are censored at date of last disease evaluation.

    Measured: Up to 10 years

  30. Progression free survival (PFS) in triplet arm

    Progression-Free Survival is defined as the time from treatment start to the earlier of progression or death due to any cause. Participants alive without disease progression are censored at date of last disease evaluation.

    Measured: Up to 10 years

  31. Overall Survival (OS)

    Overall Survival is defined as the time from treatment start to death due to any cause, or censored at date last known alive.

    Measured: Up to 10 years

  32. Overall Survival (OS) in doublet arm

    Overall Survival is defined as the time from treatment start to death due to any cause, or censored at date last known alive.

    Measured: Up to 10 years

  33. Overall Survival (OS) in triplet arm

    Overall Survival is defined as the time from treatment start to death due to any cause, or censored at date last known alive.

    Measured: Up to 10 years

  34. Rate of peripheral blood (PB) MRD-negativity after 6 cycles of induction therapy

    Peripheral blood MRD will be measured by the clonoSEQ assay.

    Measured: Up to 125 weeks

  35. Rate of peripheral blood (PB) MRD-negativity after 12 cycles of maintenance treatment in doublet arm

    Peripheral blood MRD will be measured by the clonoSEQ assay.

    Measured: Up to 125 weeks

  36. Rate of peripheral blood (PB) MRD-negativity after 12 cycles of maintenance treatment in triplet arm

    Peripheral blood MRD will be measured by the clonoSEQ assay.

    Measured: Up to 125 weeks

  37. Rate of peripheral blood (PB) MRD-negativity after 24 cycles of maintenance treatment in doublet arm

    Peripheral blood MRD will be measured by the clonoSEQ assay.

    Measured: Up to 125 weeks

  38. Rate of peripheral blood (PB) MRD-negativity after 24 cycles of maintenance treatment in triplet arm

    Peripheral blood MRD will be measured by the clonoSEQ assay.

    Measured: Up to 125 weeks

  39. Best rate of peripheral blood (PB) MRD-negativity after up to 24 cycles of maintenance treatment in doublet arm

    Peripheral blood MRD will be measured by the clonoSEQ assay.

    Measured: Up to 125 weeks

  40. Best rate of peripheral blood (PB) MRD-negativity after up to 24 cycles of maintenance treatment in triplet arm

    Peripheral blood MRD will be measured by the clonoSEQ assay.

    Measured: Up to 125 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2025
  2. Study start22 Apr 2025
  3. Primary completion1 Nov 2029 (estimated)
  4. Study completion1 Nov 2039 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Model description
Induction therapy phase followed by randomized, maintenance therapy phase. Participants will be randomized to Arms A or B, but Arm B participants requiring ramp up for Sonrotoclax, will be placed in Arm B Ramp Up.
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06854003
Sponsor's protocol ID
24-654
Acronym
BRAZAN
Status last verified
Feb 2026
First submitted
25 Feb 2025
Last updated
20 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: innovation@dfci.harvard.edu. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bendamustine, Rituximab and Cytarabine in people with Mantle Cell Lymphoma and Lymphoma, run by Christine Ryan at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 26 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Dana-Farber Cancer Institute Clinical Trials (877-DF-TRIAL (877-338-7425), DFCILymphomaResearchNurses@partners.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete Response Rate (CRR) after 1-year of Maintenance Treatment (time frame: Up to 125 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06854003.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026.

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