Clinical trial · Interventional
Obatoclax Mesylate, Rituximab, and Bendamustine Hydrochloride in Treating Patients With Relapsed or Refractory Non-Hodgkin Lymphoma
A Phase I/II Trial of Rituximab, Bendamustine, and Obatoclax in Patients With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): No patients accrued.
Summary
Brief summary (as posted)
This phase I/II trial is studying the side effects and the best dose of obatoclax mesylate when given together with rituximab and bendamustine hydrochloride to see how well it works compared with rituximab and bendamustine hydrochloride alone in treating patients with relapsed or refractory non-Hodgkin lymphoma. Obatoclax mesylate may stop the growth of cancer cells by blocking some of the proteins needed for cell growth. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and help kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as bendamustine hydrochloride, also work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving obatoclax mesylate together with rituximab and bendamustine hydrochloride may kill more cancer cells
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue | Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue | ALIAS | 0.90 |
| Nodal Marginal Zone B-cell Lymphoma | Nodal Marginal Zone Lymphoma | ALIAS | 0.90 |
| Recurrent Grade 1 Follicular Lymphoma | Grade 1 Follicular Lymphoma | CURATED_BROADER | 0.78 |
| Recurrent Grade 2 Follicular Lymphoma | Grade 2 Follicular Lymphoma | CURATED_BROADER | 0.78 |
| Recurrent Mantle Cell Lymphoma | Mantle Cell Lymphoma | CURATED_BROADER | 0.78 |
| Recurrent Marginal Zone Lymphoma | Marginal Zone Lymphoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bendamustine hydrochloride | Drug | Bendamustine | ALIAS |
| obatoclax mesylate | Drug | — | UNRESOLVED |
| rituximab | Biological | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients receive obatoclax mesylate IV over 3 hours on days 1-3, rituximab IV over 4-8 hours on day 1, and bendamustine hydrochloride IV over 30 minutes on days 1-2.
- interventionNames
- Drug: bendamustine hydrochloride
- Drug: obatoclax mesylate
- Biological: rituximab
- type
- EXPERIMENTAL
- label
- Arm II
- description
- Patients receive rituximab and bendamustine hydrochloride as in arm I.
- interventionNames
- Drug: bendamustine hydrochloride
- Biological: rituximab
Primary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed indolent B-cell non-Hodgkin lymphoma (NHL), including any of the following subtypes recognized by WHO classification: * Marginal zone lymphoma * Lymphoplasmacytic lymphoma * Follicular lymphoma * Mantle cell lymphoma * Transformed lymphoma from a low-grade, indolent NHL allowed provided patient has received ≥ 1 prior therapy for indolent disease * Must have received ≥ 1 prior therapy * Relapsed disease after autologous or allogeneic stem cell transplantation (SCT) allowed (phase I) * No relapse after allogeneic SCT (phase II) * No known CNS lymphoma * ECOG performance status 0-2 * ANC ≥ 1,000/µL * Platelet count ≥ 50,000/µL * Total bilirubin ≤ 1.5 times upper limit of normal (ULN) * AST and ALT ≤ 2.5 times ULN * Creatinine ≤ 2.0 mg/dL OR creatinine clearance ≥ 50 mL/min * Not pregnant or nursing * Fertile patients must use effective contraception prior to and for the duration of study participation * No active hepatitis B infection * Patients with a history of hepatitis B (surface antigen or core antibody positive) must take lamivudine or equivalent during study therapy * No history of documented human anti-globulin antibodies, or a history of allergic reactions attributed to compounds of similar chemical or biologic composition to rituximab, bendamustine hydrochloride, or obatoclax mesylate * No uncontrolled intercurrent illness including, but not limited to, any of the following: * Ongoing or active infection * Symptomatic congestive heart failure * Unstable angina pectoris * Cardiac arrhythmia * Psychiatric illness and/or social situations that would limit compliance with study requirements * HIV infection allowed provided patient meets the following criteria: * No evidence of co-infection with hepatitis B or C * CD4 cell count ≥ 400/mm³ * No evidence of resistant strains of HIV * HIV viral load ≤ 10,000 copies HIV RNA/mL for patients not on anti-HIV combination antiretroviral therapy OR HIV viral load ≤ 50,000 copies HIV RNA/mL for patients on anti-HIV therapy * No history of AIDS-defining conditions * No active secondary malignancy except for non-melanomatous skin cancer * No other concurrent investigational agents * Prior bendamustine hydrochloride allowed provided patient has completed a bendamustine-containing regimen within the past 6 months and achieved a partial response or better * More than 4 weeks since prior chemotherapy or radiotherapy (6 weeks for nitrosoureas or mitomycin C) and recovered
References
Publications (0)
Data not yet available