Mantle Cell LymphomaPhase 2PrE0405NCT03834688
Phase II Study of Bendamustine and Rituximab Plus Venetoclax in Untreated Mantle Cell Lymphoma Over 60 Years of Age
A Phase 2 study testing Venetoclax, Bendamustine and Rituximab in people with Mantle Cell Lymphoma, run by PrECOG, LLC. at 7 sites in United States.
Trial summary
Eligible untreated patients will receive single arm venetoclax, bendamustine and rituximab as induction therapy. After 6 cycles, maintenance rituximab may be administered per physician discretion. Venetoclax is an oral Bcl-2 family protein inhibitor. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Mantle Cell Lymphoma
- What is being tested?
- Venetoclax, Bendamustine and Rituximab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 7 sitesUnited States
- Study dates
- 13 Jan 2020to 26 Jul 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have histologically confirmed (biopsy-proven) diagnosis of mantle cell lymphoma (MCL), with documented cyclin D1 (BCL1) expression by immunohistochemical stains and/or t(11;14) by cytogenetics or Fluorescence In Situ Hybridization (FISH).
- Patients must have measurable or evaluable disease as defined as a lymph node measuring >1.5 cm in any dimension or splenomegaly with spleen >15 cm in craniocaudal dimension.
- Age ≥ 60 years.
- No intention to undergo consolidation with high dose chemotherapy and autologous stem cell rescue (Autologous Stem Cell Transplant) in first remission.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- Ability to understand and willingness to sign Institutional Review Board (IRB)-approved informed consent.
Show all 37Show fewer
- Willing to provide mandatory tissue samples (if sufficient tissue available), bone marrow and blood samples for research purposes.
- Adequate organ function as measured by the following criteria, obtained ≤ 2 weeks prior to registration:
- Absolute Neutrophil Count (ANC) ≥ 1000/mm³
- Hemoglobin ≥ 8 g/dL
- Platelets ˃75,000/mm³
- Creatinine clearance ≥ 40 mL/min, calculated with the use of 24-hour creatinine clearance or by Cockcroft-Gault formula
- Total Bilirubin ≤ 1.5x Upper Limit of Normal (ULN) or ≤ 3x ULN for patients with documented Gilbert's syndrome
- Aspartate aminotransferase (AST)/ alanine aminotransferase (ALT) ≤ 2.5x ULN
- All females of childbearing potential (not surgically sterilized and between menarche and 1 year post menopause) must have a blood test to rule out pregnancy within 2 weeks prior to registration.
- Women must not be pregnant or breastfeeding. Females of childbearing potential who are sexually active with a non-sterilized male partner and sexually active men must agree to use 2 methods of adequate contraception (hormonal plus barrier or 2 barrier forms) prior to study entry, for the duration of study participation, and for 12 months after last dose of therapy. Method of contraception must be documented.
- Patients should not have prior chemotherapy, radiotherapy or immunotherapy for lymphoma.
- Patients must have no recent (<1 year) history of malignancy except for the following:
- adequately treated non-melanoma skin cancer
- adequately treated Stage I melanoma of the skin
- in situ cervical cancer
- low grade prostate adenocarcinoma (Gleason grade ≤ 6) managed with observation and stable for 6 months.
- Patients should not have known evidence of central nervous system (CNS) lymphoma.
- Patients must not have received a prior allogeneic stem cell transplant or solid organ transplant (except for cornea) for any indication.
- Patients must have no active, uncontrolled infections.
- Patients must not have active hepatitis B or be chronic carriers of hepatitis B. This is defined as patients with hepatitis B surface antigen (HBsAg) positive. Patients with prior exposure to hepatitis B (hepatitis B core antibody (anti-HBc) positive AND HBsAg negative) are allowed with a protective level hepatitis B surface antibody AND a negative hepatitis B viral load by polymerase-chain reaction (PCR).
- Patients must not have active hepatitis C (HCV) as defined by a hepatitis C viral load detectable by PCR. Patients with a negative HCV antibody are assumed to have a negative HCV viral load. Patients with a positive HCV antibody must have a negative hepatitis C viral load by PCR. Prior treatment for an active HCV infection will be allowed as long as the hepatitis C viral load by PCR is negative.
- Patients must not have known active Human Immunodeficiency Virus (HIV). Testing not required in absence of clinical suspicion.
- Patients must not have evidence of significant, uncontrolled concomitant diseases, including psychiatric diseases, that could affect compliance with the protocol or interpretation of results or that could increase risk to the patient.
- Patients must not have conditions that preclude oral administration or absorption of medications through the GI tract, including but not limited to the inability to swallow pills or malabsorption syndromes.
- Patients must not have known allergies to both xanthine oxidase inhibitors and rasburicase.
- Patients must not require the use of warfarin. Blood thinners of other classes are permitted.
- Patient may not receive the following agents within 7 days prior to the first dose of venetoclax:
- Strong and moderate CYP3A inhibitors
- Strong and moderate CYP3A inducers
- Strong and moderate P-gp inhibitors
- Patients must not have consumed grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges), or star fruit within 3 days prior to the first dose of venetoclax.
Who cannot join
None listed.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
St. Joseph Mercy Hospital Cancer Care Center
Ann Arbor, Michigan, 48106
University of Virginia Health System
Charlottesville, Virginia, 22903
Penn State Cancer Institute
Hershey, Pennsylvania, 17033
Indiana University Simon Cancer Center
Indianapolis, Indiana, 46202
Mayo Clinic
Rochester, Minnesota, 55905
Washington University School of Medicine Siteman Cancer Center
St Louis, Missouri, 63110
Carle Cancer Center
Urbana, Illinois, 61801
About this study
Eligible untreated patients will receive single arm venetoclax, bendamustine and rituximab as induction therapy. After 6 cycles, maintenance rituximab may be administered per physician discretion.
Venetoclax is an oral Bcl-2 family protein inhibitor. It targets the B-cell lymphoma 2 (BCL-2) protein, which supports cancer cell growth and is overexpressed in many patients with mantle cell lymphoma. Venetoclax may make the cancer cells sensitive to chemotherapy. This may help to slow down the growth of cancer or may cause cancer cells to die.
The purpose of this study is to see if venetoclax in combination with bendamustine and rituximab chemotherapy is effective in treating people who have mantle cell lymphoma and to examine the side effects, good and bad, associated with this combination.
Read the detailed description
Mantle cell lymphoma (MCL) is a subtype of Non-Hodgkin Lymphoma (NHL) which is considered incurable with conventional therapy. With an incidence of approximately 70,000 cases diagnosed in the United States (US) per year, the disease is rare.
This is an open-label phase II study of venetoclax in combination with bendamustine and rituximab. Patients will receive induction therapy with venetoclax, bendamustine and rituximab for six cycles (1 cycle = 28 days). There will be an interim analysis after 19 patients are enrolled to evaluate for tumor lysis syndrome (TLS). TLS is caused by the fast breakdown of cancer cells which can lead to electrolyte and kidney problems.
Tumor assessments will be performed after Cycle 3-4 and at end of induction therapy.
Mandatory pre-treatment tumor tissue sample (i.e., obtained in the course of standard biopsy or surgery) will be required for research (if sufficient tissue is available).
Mandatory bone marrow aspirate (obtained in the course of standard biopsy) and peripheral blood sample will be collected at the end of treatment for Minimal Residual Disease (MRD). MRD measures the disease remaining after treatment. Optional peripheral blood samples will also be collected for future research.
10/11/2021: Due to slower than anticipated enrollment, the study was redesigned to reflect the current historical complete response rate and with a lowered sample size for prompt primary endpoint readout.
- Conditions
- Mantle Cell Lymphoma
- Being tested
- Venetoclax, Bendamustine, Rituximab
- Keywords
- Venetoclax, Bendamustine, Rituximab, Bcl-2 Family Protein Inhibitor
- Medical subject headings
- Lymphoma, Mantle-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VenetoclaxDrug
Also called GDC-0199, ABT-199, RO5537382
Cycle 1: Venetoclax by mouth daily. The dose will gradually increase during Cycle 1. (Day 1-7: 20 mg; Day 8-14: 50 mg; Day 15-21: 100 mg; Day 22-28: 200 mg.)
Cycles 2-6: Venetoclax 400 mg by mouth daily on Days 1-10 (1 cycle = 28 days).
BendamustineDrug
Also called Bendamustine hydrochloride
Cycle 1-6: Bendamustine 90 mg/m² intravenous (IV) on Days 1 and 2 of each cycle. Bendamustine may be started at 70 mg/m² in patients over the age of 75 years with comorbid conditions or patients over the age of 80 years without comorbid conditions.
RituximabDrug
Also called Chimeric anti-CD20 monoclonal antibody, Rituxan
Cycle 1-6: Rituximab 375 mg/m² IV on Day 1 of each cycle. After 2 consecutive cycles of Rituximab IV are well tolerated, Rituximab may be given subcutaneously.
| Study group | Role | What they receive |
|---|---|---|
| Induction | Experimental | Venetoclax, bendamustine and rituximab as induction therapy for 6 cycles of 28 days. Receives: Drug: Venetoclax; Drug: Bendamustine; Drug: Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Response (CR) Rate at End of Induction
Complete Response (CR) was assessed in accordance with the Lugano Classification Criteria using PET/CT scans (at baseline) and PET/CT or CT scans (during follow-up). Based on this criteria, a Deauville score ≤ 3 corresponds to a CR, a score of 4 or 5 and ≥ 50% decrease in the sum of lesion measurements corresponds to a Partial Response (PR), a score of 4 or 5 and <50% decrease in sum of lesion measurements corresponds to a Stable Disease (SD), a score of 4 or 5 and >1.5cm increase in a single lesion or presence of new lesions or bone marrow recurrence denotes Progressive Disease (PD).
Measured: Complete Response (CR) status was assessed after 6 months of induction treatment, plus an additional 2 months for end of treatment PET/CT scans.
Secondary outcomes (4)
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v5.0
Number of participants with abnormal laboratory values and/or adverse events including Tumor Lysis Syndrome (TLS) were assessed using CTCAE v5.0. The adverse events were graded on a scale of 1 to 5 based on severity: grade 1 is mild, grade 2 is moderate, grade 3 is severe, grade 4 is life-threatening, and grade 5 resulted in death.
Measured: Adverse events were reported throughout 6 months of induction treatment and up to 2 months following completion of induction treatment
Overall Response
Objective response was assessed in accordance with the Lugano Classification Criteria using PET/CT scans (at baseline) and PET/CT or CT scans (during follow-up). Objective response is defined as the number of patients with a best treatment response of complete (CR) or partial response (PR).
Measured: Objective response was assessed after 6 months of induction treatment, plus an additional 2 months for end of treatment PET/CT scans.
Progression-Free Survival (PFS)
Progression-Free Survival (PFS) is a measure of patients that are alive and progression-free. Survival status is ascertained via direct contact and disease progression was assessed in accordance with the Lugano Classification Criteria using PET/CT scans (at baseline) and PET/CT or CT scans (during follow-up).
Measured: Progression-Free Survival (PFS) was assessed from the start to completion of induction treatment (6 months) through the completion of maintenance treatment (24 months) for up to 48 months. PFS at the 4-year timepoint was estimated and reported.
Overall Survival (OS)
Patients' survival status was measured by direct contact. The proportion of patients that are alive at the 4-year study timepoint is reported.
Measured: Overall survival (OS) was assessed from the start to completion of induction treatment (6 months) through the completion of maintenance treatment (24 months) for up to 48 months. OS at the 4-year timepoint was estimated and reported.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2019
- Study start13 Jan 2020
- Primary completion20 Oct 2022
- Study completion26 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Mantle Cell LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Model description
- Open-Label, Single-Arm Study, Cycle 1 Dose Escalation
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- PrECOG, LLC.
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- Craig Portell, MD, Study chair, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03834688
- Sponsor's protocol ID
- PrE0405
- Other IDs
- ML40551
- Acronym
- PrE0405
- Status last verified
- Aug 2025
- First submitted
- 6 Feb 2019
- Last updated
- 11 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Data is proprietary
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Bendamustine and Rituximab Plus Venetoclax in Untreated Mantle Cell Lymphoma Over 60 Years of Age
- ClinicalTrials.gov ID
- NCT03834688
- Acronym / sponsor ID
- PrE0405 / PrE0405
- Conditions
- Mantle Cell Lymphoma
- Keywords
- Venetoclax, Bendamustine, Rituximab, Bcl-2 Family Protein Inhibitor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- PrECOG, LLC.University, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- 13 Jan 2020 (actual)
- Primary completion
- 20 Oct 2022 (actual)
- Study completion
- 26 Jul 2024 (actual)
- First posted
- 8 Feb 2019 (actual)
- Results
- Posted 23 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Eligible untreated patients will receive single arm venetoclax, bendamustine and rituximab as induction therapy. After 6 cycles, maintenance rituximab may be administered per physician discretion.
Venetoclax is an oral Bcl-2 family protein inhibitor. It targets the B-cell lymphoma 2 (BCL-2) protein, which supports cancer cell growth and is overexpressed in many patients with mantle cell lymphoma. Venetoclax may make the cancer cells sensitive to chemotherapy. This may help to slow down the growth of cancer or may cause cancer cells to die.
The purpose of this study is to see if venetoclax in combination with bendamustine and rituximab chemotherapy is effective in treating people who have mantle cell lymphoma and to examine the side effects, good and bad, associated with this combination.
Detailed description
Mantle cell lymphoma (MCL) is a subtype of Non-Hodgkin Lymphoma (NHL) which is considered incurable with conventional therapy. With an incidence of approximately 70,000 cases diagnosed in the United States (US) per year, the disease is rare.
This is an open-label phase II study of venetoclax in combination with bendamustine and rituximab. Patients will receive induction therapy with venetoclax, bendamustine and rituximab for six cycles (1 cycle = 28 days). There will be an interim analysis after 19 patients are enrolled to evaluate for tumor lysis syndrome (TLS). TLS is caused by the fast breakdown of cancer cells which can lead to electrolyte and kidney problems.
Tumor assessments will be performed after Cycle 3-4 and at end of induction therapy.
Mandatory pre-treatment tumor tissue sample (i.e., obtained in the course of standard biopsy or surgery) will be required for research (if sufficient tissue is available).
Mandatory bone marrow aspirate (obtained in the course of standard biopsy) and peripheral blood sample will be collected at the end of treatment for Minimal Residual Disease (MRD). MRD measures the disease remaining after treatment. Optional peripheral blood samples will also be collected for future research.
10/11/2021: Due to slower than anticipated enrollment, the study was redesigned to reflect the current historical complete response rate and with a lowered sample size for prompt primary endpoint readout.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open-Label, Single-Arm Study, Cycle 1 Dose Escalation
| Arm | Type | Receives |
|---|---|---|
| Induction | Experimental | Drug: Venetoclax, Drug: Bendamustine, Drug: RituximabVenetoclax, bendamustine and rituximab as induction therapy for 6 cycles of 28 days. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (37 listed)
- Patients must have histologically confirmed (biopsy-proven) diagnosis of mantle cell lymphoma (MCL), with documented cyclin D1 (BCL1) expression by immunohistochemical stains and/or t(11;14) by cytogenetics or Fluorescence In Situ Hybridization (FISH).
- Patients must have measurable or evaluable disease as defined as a lymph node measuring >1.5 cm in any dimension or splenomegaly with spleen >15 cm in craniocaudal dimension.
- Age ≥ 60 years.
- No intention to undergo consolidation with high dose chemotherapy and autologous stem cell rescue (Autologous Stem Cell Transplant) in first remission.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VenetoclaxAlso: GDC-0199, ABT-199, RO5537382Cycle 1: Venetoclax by mouth daily. The dose will gradually increase during Cycle 1. (Day 1-7: 20 mg; Day 8-14: 50 mg; Day 15-21: 100 mg; Day 22-28: 200 mg.) Cycles 2-6: Venetoclax 400 mg by mouth daily on Days 1-10 (1 cycle = 28 days). | Drug | Induction |
| BendamustineAlso: Bendamustine hydrochlorideCycle 1-6: Bendamustine 90 mg/m² intravenous (IV) on Days 1 and 2 of each cycle. Bendamustine may be started at 70 mg/m² in patients over the age of 75 years with comorbid conditions or patients over the age of 80 years without comorbid conditions. | Drug | Induction |
| RituximabAlso: Chimeric anti-CD20 monoclonal antibody, RituxanCycle 1-6: Rituximab 375 mg/m² IV on Day 1 of each cycle. After 2 consecutive cycles of Rituximab IV are well tolerated, Rituximab may be given subcutaneously. | Drug | Induction |
Primary outcome
Complete Response (CR) Rate at End of Induction
Time frame: Complete Response (CR) status was assessed after 6 months of induction treatment, plus an additional 2 months for end of treatment PET/CT scans.
Complete Response (CR) was assessed in accordance with the Lugano Classification Criteria using PET/CT scans (at baseline) and PET/CT or CT scans (during follow-up). Based on this criteria, a Deauville score ≤ 3 corresponds to a CR, a score of 4 or 5 and ≥ 50% decrease in the sum of lesion measurements corresponds to a Partial Response (PR), a score of 4 or 5 and <50% decrease in sum of lesion measurements corresponds to a Stable Disease (SD), a score of 4 or 5 and >1.5cm increase in a single lesion or presence of new lesions or bone marrow recurrence denotes Progressive Disease (PD).
4 secondary outcomes
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v5.0
Time frame: Adverse events were reported throughout 6 months of induction treatment and up to 2 months following completion of induction treatment
Overall Response
Time frame: Objective response was assessed after 6 months of induction treatment, plus an additional 2 months for end of treatment PET/CT scans.
Progression-Free Survival (PFS)
Time frame: Progression-Free Survival (PFS) was assessed from the start to completion of induction treatment (6 months) through the completion of maintenance treatment (24 months) for up to 48 months. PFS at the 4-year timepoint was estimated and reported.
Overall Survival (OS)
Time frame: Overall survival (OS) was assessed from the start to completion of induction treatment (6 months) through the completion of maintenance treatment (24 months) for up to 48 months. OS at the 4-year timepoint was estimated and reported.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Data is proprietary
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Craig Portell, MD study chair
University of Virginia
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Venetoclax, Bendamustine and Rituximab in people with Mantle Cell Lymphoma, run by PrECOG, LLC. 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 37 inclusion and 0 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: finished, as of the sponsor's last update on 11 Aug 2025. 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?
Yes. Results are posted in the registry (first posted 23 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Response (CR) Rate at End of Induction (time frame: Complete Response (CR) status was assessed after 6 months of induction treatment, plus an additional 2 months for end of treatment PET/CT scans.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Aug 2025.