A Phase 1/2 interventional study of rituximab and bendamustine hydrochloride in Lymphoma, sponsored by Swiss Group for Clinical Cancer Research. Completed at 16 sites in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-05-15.
Sponsored by Swiss Group for Clinical Cancer Research · Phase 1/2, Interventional, and Treatment
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer cell growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cell-killing substances to them. Drugs used in chemotherapy, such as bendamustine hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Lenalidomide may stop the growth of cancer by blocking blood flow to the tumor. Giving rituximab together with bendamustine hydrochloride and lenalidomide may kill more cancer cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of giving rituximab together with bendamustine hydrochloride and lenalidomide in treating patients with aggressive B-cell lymphoma.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter, phase I dose-escalation study of bendamustine hydrochloride and lenalidomide followed by a phase II study.
Patients receive rituximab IV on day 1, bendamustine hydrochloride IV over 30-60 minutes on days 1-2, and oral lenalidomide on days 1-21. Courses repeat every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients on phase II study complete the SAKK Cancer-Specific Geriatric Assessment at baseline and after completion of course 1. Patients also complete quality-of-life questionnaires at baseline and periodically during study.
After completion of study therapy, patients are followed for up to 2 years.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's enrollment of 49 is above the median of 40 across 4,508 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →Swiss Group for Clinical Cancer Research is the lead sponsor of 107 studies on the registry; none are open to participants now.
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DISEASE CHARACTERISTICS:
Histologically confirmed aggressive B-cell non-Hodgkin lymphoma, including any of the following:
Meets 1 of the following criteria:
No known CNS involvement
PATIENT CHARACTERISTICS:
WHO performance status (PS) 0-2
No serious underlying medical condition that, in the judgement of the investigator, could impair the ability of the patient to participate in the trial including, but not limited to, any of the following conditions:
PRIOR CONCURRENT THERAPY:
Biological: rituximab · Drug: bendamustine hydrochloride · Drug: lenalidomide
day 1 at a fixed dose of 375mg/m2
Also known as: MabThera, Rituxan
Bendamustine at day 1 and 2 according to the dose escalation in phase I, and at the recommended dose in phase II: 70mg/m2.
Also known as: Cephalon
Lenalidomide at days 1-21 according to the dose escalation in phase I, and at the recommended dose in phase II: 10mg
Also known as: Revlimid
Dose-limiting toxicity (phase I)
Time frame: at 4 weeks.
Maximum-tolerated dose (phase I)
Time frame: at the end of phase I (31 August 2011)
Objective response (complete and partial response) (phase II)
Time frame: phase II (3 years)
Adverse events according to NCI CTCAE v. 3.0
Time frame: All AEs will be assessed according to NCI CTCAE v3.0 until 30 days after trial therapy end.
Event-free survival (phase II)
Time frame: up to 30 months for each patient.
Response duration (phase II)
From the time when criteria for response (CR/CRu or PR) are met, until documentation of relapse or progression thereafter. Only patients with a response (CR/ CRu or PR) shall be included in this analysis. Patients with no disease progression or relapse shall be censored at the last time they were known to be in remission
Time frame: up to 30 months for each patient.
Time to progression (phase II)
Defined as the time from registration until documented lymphoma progression or death as a result of lymphoma. Patients not experiencing an event will be censored at the last time they were known to be in remission
Time frame: up to 30 months for each patient.
Overall survival (phase II)
Time frame: up to 30 months for each patient.
Quality of life
Time frame: approx. 5 months for each patient.
Usefulness and feasibility of the SAKK C-SGA
Time frame: End of phase II (excluding follow-up) at 3 years.
Association between WHO performance status, QOL indicators, and SAKK C-SGA scores
Time frame: End of phase II (excluding follow-up) at 3 years.
Progression Free Survival (PFS)
Time from registration until one of the following events (whichever occurs first): * Relapse or progression assessed according to the International Workshop NHL criteria (1999) * Death of any cause
Time frame: up to 30 months for each patient.
Plan to share: No
This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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Swiss Group for Clinical Cancer Research