Bortezomib and Rituximab in Treating Patients With Mantle Cell Lymphoma Who Have Previously Undergone Stem Cell Transplantation

Part of paid clinical trials in Duarte, California.

Sponsor
City of Hope Medical Center
Study ID
NCT01267812
Phase
PHASE2
Status
Completed

Conditions

  • Contiguous Stage II Mantle Cell Lymphoma
  • Noncontiguous Stage II Mantle Cell Lymphoma
  • Recurrent Mantle Cell Lymphoma
  • Stage I Mantle Cell Lymphoma
  • Stage III Mantle Cell Lymphoma
  • Stage IV Mantle Cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • bortezomib — DRUG
    Given SC or IV
  • rituximab — BIOLOGICAL
    Given IV
  • laboratory biomarker analysis — OTHER
    Correlative studies
  • immunohistochemistry staining method — OTHER
    Correlative studies
  • RNA analysis — GENETIC
    Correlative studies
  • gene expression analysis — GENETIC
    Correlative studies
  • DNA analysis — GENETIC
    Correlative studies
  • pharmacological study — OTHER
    Correlative studies
  • pharmacogenomic studies — OTHER
    Correlative studies
  • Questionnaire Administration — OTHER

Study Details

RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. 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 rituximab may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving bortezomib and rituximab together works in treating patients with mantle cell lymphoma who have previously undergone stem cell transplantation

Key Dates

Start date
Oct 3, 2011
Status verified
Jul 2023
Primary completion
Nov 2, 2020
Completion
Nov 2, 2020

Study Design

Enrollment
23 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (bortezomib and rituximab)
    Doses of bortezomib given is 1.3 mg/m2 weekly x 4 weeks given every 3 month x 8 cycles. Doses of RITUXAN given is 375 mg/m2 give weekly x 4 weeks given every 6 month for 4 cycles.

Primary Outcome Measure

Two-year Disease-free Survival [ Time Frame: Participants were followed up to 5 years after initial treatment and Kaplan-Meier survival analysis was used to generate the two-year disease-free survival estimate presented. ]

Locations (2)

FacilityCityStateZIPSite coordinators
City of Hope Medical CenterDuarteCalifornia91010-
Fred Hutchinson Cancer Research Center/University of Washington Cancer ConsortiumSeattleWashington98109-

Find similar trials in Duarte, CA

By research site
City of Hope Medical Center· Duarte, CAFred Hutchinson Cancer Research Center/University of Washington Cancer Consortium· Seattle, WA

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