Bortezomib After Combination Chemotherapy, Rituximab, and an Autologous Stem Cell Transplant in Treating Patients With Mantle Cell Lymphoma
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) together with an autologous stem cell transplant may allow more chemotherapy to be given so that more cancer cells are killed. 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 after combination chemotherapy, monoclonal antibody therapy, and an autologous stem cell transplant may kill any remaining cancer cells or keep the cancer from coming back.
PURPOSE: This randomized phase II trial is studying how well bortezomib works when given after combination chemotherapy, rituximab, and an autologous stem cell transplant in treating patients with mantle cell lymphoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Drug: bortezomib |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomized Phase II Trial of Maintenance vs Consolidation Bortezomib Therapy Following Aggressive Chemo-Immunotherapy and Autologous Stem Cell Transplant for Previously Untreated Mantle Cell Lymphoma |
- Progression-free survival at 18 months [ Designated as safety issue: No ]
| Estimated Enrollment: | 150 |
| Study Start Date: | June 2006 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Arm I maintenance therapy
Patients receive bortezomib IV on days 1, 8, 15, and 22. Treatment repeats every 56 days for up to 10 courses in the absence of disease progression or unacceptable toxicity.
|
Drug: bortezomib
Given IV
|
|
Experimental: Arm II consolidation therapy
Patients receive bortezomib IV on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
|
Drug: bortezomib
Given IV
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed mantle cell lymphoma, meeting the following criteria:
Stage I-IV disease
- Patients with nodular histology must have stage III or IV disease
- Co-expression of CD20 (or CD19) and CD5 AND lack of CD23 expression by immunophenotyping
At least 1 of the following confirmatory tests:
- Positive immunostaining for cyclin D1
- Presence of t(11;14) on cytogenetic analysis
- Molecular evidence of bcl-1/IgH rearrangement
- Previously untreated disease OR ≤ 1 prior course of chemotherapy and/or rituximab
- No mantle zone histology
- No Waldenstrom's macroglobulinemia
- No active CNS disease defined as symptomatic meningeal lymphoma
- No known CNS parenchymal lymphoma
PATIENT CHARACTERISTICS:
- LVEF ≥ 45% by MUGA or echocardiogram
- Creatinine ≤ 2.0 mg/dL
Patients testing positive for hepatitis B surface antigen or hepatitis C antibody are eligible provided all of the following criteria are met:
- Bilirubin ≤ 2 times upper limit of normal (ULN)
- AST ≤ 3 times ULN
- Fibrosis ≤ grade 2 fibrosis AND no cirrhosis by liver biopsy
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No known hypersensitivity to murine products
- No medical condition requiring chronic use of oral corticosteroids
- No known HIV positivity
No currently active second malignancy other than nonmelanoma skin cancer
- Patients are not considered to have a currently active malignancy if they have completed anticancer therapy and are considered to have < 30% risk of relapse
PRIOR CONCURRENT THERAPY:
- At least 2 weeks since prior major surgery
- At least 3 weeks since prior chemotherapy
- No prior radiotherapy for mantle cell lymphoma
No other concurrent hormonal therapy or chemotherapy except for the following:
- Corticosteroids for adrenal failure, diffuse alveolar hemorrhage, or carmustine pneumonitis
- Dexamethasone as an antiemetic or premedication for rituximab
- Hormones for nonlymphoma-related conditions (e.g., insulin for diabetes)
Contacts and Locations
Show 48 Study Locations| Study Chair: | Lawrence D. Kaplan, MD | University of California, San Francisco |
More Information
Additional Information:
No publications provided
| Responsible Party: | Monica M. Bertagnolli, Cancer and Leukemia Group B |
| ClinicalTrials.gov Identifier: | NCT00310037 History of Changes |
| Other Study ID Numbers: | CDR0000466167, CALGB-50403 |
| Study First Received: | March 29, 2006 |
| Last Updated: | September 6, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
contiguous stage II mantle cell lymphoma noncontiguous stage II mantle cell lymphoma stage I mantle cell lymphoma |
stage III mantle cell lymphoma stage IV mantle cell lymphoma recurrent mantle cell lymphoma |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, Mantle-Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
Lymphoma, Non-Hodgkin Bortezomib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013