Phase 2
Completed N=30
Pilot Study of Bortezomib, Bendamustine and Rituximab on Non-Hodgkin's Lymphoma
Source: ClinicalTrials.gov NCT00547534 ↗Enrolled (actual)
30
Serious AEs
43.3%
Results posted
Jun 2011
Primary outcomePrimary: Number of Participants With Progression Free Survival at 2 Years — 13 Participants
Summary
The purpose of this study is to evaluate how non-Hodgkin's lymphoma that has not responded to, or that has returned after standard treatment, responds to bortezomib, rituximab and bendamustine, and also to see what effects this drug combination have on this cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Progression Free Survival at 2 Years |
13 | — |
| SECONDARY Toxicity of Drug Combination in the Subjects |
13 | — |
| SECONDARY Overall Response Rate (ORR) |
13 | — |
Eligibility Criteria
Inclusion Criteria
- Voluntary written informed consent before performance of any study-specific procedure not part of routine medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
- Female subject is either post-menopausal or surgically sterilized or willing to use acceptable method of birth control for duration of study.
- Male subject agrees to use acceptable method for contraception for duration of study.
- Histologically-confirmed indolent or mantle cell lymphoma, utilizing the World Health Organization (WHO) classification. The biopsy must fulfill one of the following criteria:
- Follicular lymphoma, grades 1-3
- Marginal zone lymphoma
- Small lymphocytic lymphoma (circulating lymphocyte count must be 6 months, then patient is allowed to enroll on the study.
- Patient has concomitant active malignancy requiring therapy
- Patient is known to be HIV positive (test result not required for enrollment).
- History of solid organ transplantation, or post transplant lymphoproliferative disorder
- Patient has history of allogeneic stem cell transplantation.
- Patient has history of autologous stem cell transplantation or radioimmunotherapy within the previous 4 months.
- Patient has received any other investigational drugs within 14 days prior to enrollment
- History of, or clinically apparent CNS lymphoma
- Any clinically significant abnormality in screening blood chemistry, hematology, or urinalysis results that, in the judgment of the investigator, would impede adequate evaluation of adverse events and/or response to treatment, or that requires aggressive intervention
Data sourced from ClinicalTrials.gov (NCT00547534). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.