Phase 2
N=24
Bortezomib, Cladribine, and Rituximab in Treating Patients With Advanced Mantle Cell Lymphoma or Indolent Lymphoma
Lymphoma · Mantle Cell Lymphoma · Indolent Lymphoma · SLL
Bottom Line
View on ClinicalTrials.gov: NCT00980395 ↗Enrolled (actual)
24
Serious AEs
58.3%
Results posted
Oct 2019
Primary outcome: Primary: Progression-free Survival at 2 Years — 15 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- rituximab (Drug); bortezomib (Drug); cladribine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Arizona
- Primary completion
- Sep 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-free Survival at 2 Years |
15 | — |
| SECONDARY Overall Survival at 2 Years |
18 | — |
| SECONDARY Complete Response Rate |
8 | — |
| SECONDARY Partial Response |
14 | — |
Summary
RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cladribine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer 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 cancer-killing substances to them. Giving bortezomib together with cladribine and rituximab may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving bortezomib together with cladribine and rituximab works in treating patients with advanced mantle cell lymphoma or indolent lymphoma.
Eligibility Criteria
Inclusion Criteria
- Voluntary consent before performance of any study-related procedure
- Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control
- Male subject agrees to use an acceptable method for contraception for the duration of the study.
- Biopsy-proven mantle cell, marginal zone, lymphoplasmacytic, small lymphocytic lymphoma, or follicular lymphoma
- CD20-positive disease
- Patients with marginal zone, lymphoplasmacytic, small lymphocytic, or follicular lymphoma - at least one criterion for initiation of treatment must be met:
- Symptomatic disease
- Cytopenia related to lymphoma
- Leukemic phase (> 5,000 malignant lymphocytes/µl)
- Mass over 5 cm in greatest diameter
- For lymphoplasmacytic lymphoma: additional treatment criteria are serum viscosity ≥ 4 cp, serum monoclonal protein > 5 g/L, concurrent primary systemic AL amyloidosis, cold agglutinin disease
- Age over 18
- Prior treatment with bortezomib and/or rituximab is acceptable
- For follicular lymphoma only, at least one prior treatment
Exclusion Criteria
- Platelet count of 1.5 X ULN Total Bilirubin
- Radiation therapy within 3 weeks before randomization. Enrollment of subjects who require concurrent radiotherapy (which must be localized in its field size) should be deferred until the radiotherapy is completed and 3 weeks have elapsed since the last date of therapy.
Data sourced from ClinicalTrials.gov (NCT00980395). 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.