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Bortezomib After Combination Chemotherapy, Rituximab, and an Autologous Stem Cell Transplant in Treating Patients With Mantle Cell Lymphoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00310037
First received: March 29, 2006
Last updated: September 6, 2012
Last verified: June 2010
  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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00310037

  Show 48 Study Locations
Sponsors and Collaborators
Cancer and Leukemia Group B
Investigators
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
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Bortezomib
Antineoplastic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014