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

NCT00439556 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2019-09-10

Study results available
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Summary

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.

Conditions

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

Interventions

PROCEDURE

Allogeneic Hematopoietic Stem Cell Transplantation

Undergo allogeneic hematopoietic stem cell transplantation

BIOLOGICAL

Anti-Thymocyte Globulin

Given IV

DRUG

Bortezomib

Given IV

DRUG

Carmustine

Given IV

DRUG

Cytarabine

Given IV

DRUG

Etoposide

Given IV

BIOLOGICAL

Filgrastim

Given SC

DRUG

Melphalan

Given IV

DRUG

Methotrexate

Given IV

BIOLOGICAL

Rituximab

Given IV

DRUG

Tacrolimus

Given IV and PO

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Issa Khouri · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-02-13
Primary Completion
2018-06-07
Completion
2018-06-07
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00439556 on ClinicalTrials.gov