Bortezomib and Chemotherapy in Treating Participants With Lymphoid Malignancies Undergoing Stem Cell Transplant

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT00439556
Phase
PHASE2
Status
Completed

Conditions

  • CD20 Positive
  • Hematopoietic and Lymphoid Cell Neoplasm
  • Lymphocytic Neoplasm
  • Lymphoma

Eligibility Criteria

Sex
ALL
Age
N/A - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Allogeneic Hematopoietic Stem Cell Transplantation — PROCEDURE
    Undergo allogeneic hematopoietic stem cell transplantation
  • Anti-Thymocyte Globulin — BIOLOGICAL
    Given IV
  • Bortezomib — DRUG
    Given IV
  • Carmustine — DRUG
    Given IV
  • Cytarabine — DRUG
    Given IV
  • Etoposide — DRUG
    Given IV
  • Filgrastim — BIOLOGICAL
    Given SC
  • Melphalan — DRUG
    Given IV
  • Methotrexate — DRUG
    Given IV
  • Rituximab — BIOLOGICAL
    Given IV
  • Tacrolimus — DRUG
    Given IV and PO

Study Details

This phase II trial studies the side effects and best dose of bortezomib when given with chemotherapy and to see how well they work in treating participants with lymphoid malignancies undergoing stem cell transplant. Giving chemotherapy before a stem cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. When the healthy stem cells from a donor are infused into the participant they may help the participant's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells called graft versus host disease. Giving tacrolimus and methotrexate after the transplant may stop this from happening. Giving bortezomib and chemotherapy may work better in treating participants with lymphoid malignancies undergoing a stem cell transplant.

Key Dates

Start date
Feb 13, 2007
Status verified
Aug 2019
Primary completion
Jun 7, 2018
Completion
Jun 7, 2018

Study Design

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

Arms

  • Experimental: Treatment (chemotherapy, transplant, filgrastim, tacrolimus)
    See Detailed Description

Primary Outcome Measure

Number of Participants With Dose Limiting Toxicity (DLT) [ Time Frame: From start of treatment to 90 days after the start of treatment ]

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Houston, TX

By research site
M D Anderson Cancer Center· Houston, TX

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