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Mantle Cell LymphomaEarly Phase 1NCT03295240

The Study of Bendamustine, Rituximab, Ibrutinib, and Venetoclax in Relapsed, Refractory Mantle Cell Lymphoma

A Early Phase 1 study testing BR-I (bendamustine, rituximab, ibrutinib) and VEN (Venetoclax) in people with Mantle Cell Lymphoma and Lymphoma, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to test the safety of Venetoclax in combination with FDA approved treatments Bendamustine, Rituximab and Ibrutinib (BR-I). This study will examine the effects Venetoclax has on participants when it is given in combination with BR-I. 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?
BR-I (bendamustine, rituximab, ibrutinib) and VEN (Venetoclax)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
7 sitesUnited States
Study dates
20 Sep 2017to 22 Jan 2024
Phase
Early Phase 1
Are there results?
None posted in the registry

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

  • Age greater than or equal to 18 years
  • Histologically confirmed MCL
  • Relapse, refractory or progressive disease following at least 1 line of systemic therapy for mantle cell lymphoma
  • ECOG Performance Status </= 2
  • Patients must have completed anticancer treatment with chemotherapy, small molecule inhibitors, immune modulator drugs, biologics, and/or treatment with other anticancer agents at least 3 weeks prior treatment, or 2 weeks if progressing, and recovered from clinically significant toxicity associated with treatment
  • ° Palliative radiotherapy must have been discontinued at least 1 week prior to treatment in this study
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  • Short-course corticosteroids are allowed (≤ 10 days) and must be discontinued prior to study treatment start (Cycle 1, Day 1)
  • ° Ongoing administration of a stable dose of corticosteroid therapy (equivalent to ≤ 30 mg prednisone daily and previously received for ≥ 30 days) is permissible provided there is evidence of measurable disease and there will be no increase in steroid dose during the clinical trial
  • Patients who have been previously treated with BR or Bendamustine alone are eligible, provided they did not progress during treatment or within 6 months of completing BR or B treatment
  • Patients who have been previously treated with ibrutinib or acalabrutinib (or any alternate BTK-inhibitor) are eligible, provided they had evidence of response (at least Stable Disease, Partial Response, or Complete Response) and did not progress within 6 months of treatment initiation
  • Female subject of childbearing potential should have a negative urine or serum pregnancy within 2 weeks prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
  • A positive serum pregnancy test due to fertility preservation will not be an exclusion after physician review
  • Adequate organ function and laboratory values within the following ranges:
  • Absolute neutrophil count > 1,000 cells/mm3 (1.0 x 109L), if neutropenia is due to bone marrow involvement absolute neutrophil count must be >/= 500 cells.mm3 (0.5 x 10^9/L)
  • Platelet count > 75,000 cells/mm3 (75 x 109/L), unless thrombocytopenia is due to bone marrow involvement platelet count must be greater than 25,000 cells/mm3
  • Hemoglobin > 8.0 g/dL
  • Serum aspartate transaminase (AST) and alanine transaminase (ALT) </= 2.5 x upper limit of normal (ULN)
  • Estimate creatinine clearance (Cockcroft-Gault) >/= 40 mL/min. If creatinine clearance is < 40 mL/min, but the serum creatinine is within institutional normal limits, the patient will be eligible
  • Bilirubin <1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin)
  • For women of childbearing potential:
  • Agreement to remain abstinent (refrain from heterosexual intercourse) or use a contraceptive method with a failure rate of < 1% per year during the treatment period and for at least 30 days afte rthe last dose of venetoclax or 18 months after the last dose of rituximab, whichever is longer
  • Examples of contraceptive methods with a failure rate of < 1% per years include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices
  • A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (>/= 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus)
  • For men:
  • Agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, as defined below
  • With female partners of childbearing potential, men must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of <1% per year during the treatment period and for at least 6 months after the last dose of rituximab. Men must refrain from donating sperm during this same period.
  • With pregnant female partners, men must remain abstinent or use a condom during the treatment period and for at least 6 months after the last dose of rituximab to avoid exposing the embryo
  • The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g. calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception

Who cannot join

  • Prior therapy with venetoclax or alternate BCL-2 inhibitor
  • Any life-threatening illness, medical condition, or organ system dysfunction that, in the opinion of the investigator, could compromise the subject's safety or put the study outcomes at undue risk.
  • Unable to swallow capsules or tablets, malabsorption syndrome, disease significantly affecting gastrointestinal function, resection of the stomach or small bowel, symptomatic inflammatory bowel disease or ulcerative colitis, or partial or complete bowel obstruction or other condition that precludes enteral route of administration
  • Cerebral/meningeal disease related to the underlying malignancy. Patients with a history of cerebral/meningeal disease related to the underlying malignancy are allowed if prior central nervous system disease has been definitively treated with no evidence of disease or requirement for steroids
  • Active HIV or hepatitis B or C with positive viral load, requiring anti-viral therapy
  • Bleeding diathesis or use of warfarin or other vitamin K antagonist
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  • Prior history of infusion reactions or hypersensitivity to any of the study drugs
  • Active concurrent malignancy requiring active therapy
  • Pregnant or lactating females
  • Prior autologous stem cell transplant within 90 days of study start
  • Prior allogenic stem cell transplant within 12 months of study start
  • Patients with active graft-versus-host-disease are not eligible
  • Patients receiving immunosuppressive therapy for prevention of graft-versus-host-disease are not eligible
  • Patients who requires treatment with a potent cytochrome P450 (CYP) 3A inhibitor or inducer
  • Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment, or any major episode of infection requiring treatment with IV antibiotics or hospitalization (relating to the completion of the course of antibiotics) within 2 weeks prior to Cycle 1, Day 1
  • Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis
  • Receipt of live-virus vaccines within 28 days prior to the initiation of study treatment or need for live-virus vaccines at any time during study treatment

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites

  • Memorial Sloan Kettering Basking Ridge

    Basking Ridge, New Jersey, 07920

  • Memorial Sloan Kettering Commack

    Commack, New York, 11725

  • Memorial Sloan Kettering Westchester

    Harrison, New York, 10604

  • Memorial Sloan Kettering Monmouth

    Middletown, New Jersey, 07748

  • Memorial Sloan Kettering Bergen

    Montvale, New Jersey, 07645

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Memorial Sloan Kettering Nassau

    Uniondale, New York, 11553

Other trials in United States

About this study

Official title: Phase I Study of Bendamustine, Rituximab, Ibrutinib, and Venetoclax in Relapsed, Refractory Mantle Cell Lymphoma

The purpose of this study is to test the safety of Venetoclax in combination with FDA approved treatments Bendamustine, Rituximab and Ibrutinib (BR-I). This study will examine the effects Venetoclax has on participants when it is given in combination with BR-I.

Being tested
BR-I (bendamustine, rituximab, ibrutinib), VEN (Venetoclax)
Keywords
Mantle Cell Lymphoma, MCL, Lymphoma, Venetoclax, 17-216
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.

  • BR-I (bendamustine, rituximab, ibrutinib)Drug

    The BR-I (bendamustine, rituximab, ibrutinib) regimen will be administered for six 28-day cycles: bendamustine (90 mg/m2; (or 70mg/m2 for dose level -1); day 1 and 2 ), rituximab (375 mg/m2; day 1), and ibrutinib one pill or four 140mg capsules (560 mg oral daily; day 1-28).

  • VEN (Venetoclax)Drug

    The initial cycle 1 VEN (Venetoclax) dose ramp-up will be: 20 mg daily for 1 week, 50 mg daily for week 2, 100 mg daily for week 3, and 200 mg daily for week 4. Thereafter, VEN will be administered at a fixed dose level of 400 mg daily for varying durations of each 28-day cycle. Now also include a -2 dose level which has the reduced 3-day duration of Ventoclax 400 mg daily.

Study groups in NCT03295240
Study groupRoleWhat they receive
BR-I in combination with VENExperimentalThe BR-I (bendamustine, rituximab, ibrutinib) regimen will be administered in combination with VEN (Venetoclax).
Receives: Drug: BR-I (bendamustine, rituximab, ibrutinib); Drug: VEN (Venetoclax)

What is being measured

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

  1. Maximum tolerated dose

    Measured: 1 year

  2. Treatment related toxicity evaluated using CTCAE v4.0

    Participants symptoms will be evaluated using CTCAE v4.0

    Measured: 1 years

Timeline

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

  1. First posted27 Sep 2017
  2. Study start20 Sep 2017
  3. Primary completion22 Jan 2024
  4. Study completion22 Jan 2024

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
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03295240
Sponsor's protocol ID
17-216
Status last verified
Jan 2024
First submitted
25 Sep 2017
Last updated
13 May 2025
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing BR-I (bendamustine, rituximab, ibrutinib) and VEN (Venetoclax) in people with Mantle Cell Lymphoma and Lymphoma, run by Memorial Sloan Kettering Cancer Center 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 28 inclusion and 17 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 13 May 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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Maximum tolerated dose (time frame: 1 year). The study lists 2 primary outcomes in all. 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 NCT03295240.

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 13 May 2025.

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