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S0501 Fludarabine, Melphalan, and Donor Stem Cell Transplant Followed By Tacrolimus and Methotrexate in Treating Patients for Relapsed Lymphoma

NCT00121186 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2012-04-03

Study results available
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Summary

RATIONALE: Giving low doses of chemotherapy, such as fludarabine and melphalan, before a donor bone marrow or peripheral blood stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving tacrolimus and methotrexate after transplant may stop this from happening.

PURPOSE: This phase II trial is studying how well giving fludarabine together with melphalan followed by tacrolimus and methotrexate works in treating patients who are undergoing a donor stem cell transplant for relapsed lymphoma.

Conditions

Interventions

DRUG

fludarabine phosphate

30 mg/m\^2 on days -6 to -2 (2-6 days before transplant).

DRUG

melphalan

70 mg/m\^2 on days -3 and -2 (2-3 days before transplant).

DRUG

methotrexate

5 mg/m\^2 on days 1, 3, and 7 post-transplant.

DRUG

tacrolimus

0.03 mg/kg bid on days -3 to 100 post-transplant.

PROCEDURE

allogeneic bone marrow transplantation

if donor bone marrow stem cells are harvested

PROCEDURE

peripheral blood stem cell transplantation

if donor peripheral blood stem cells are harvested

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • SWOG Cancer Research Network

    lead NETWORK

Principal Investigators

  • Patrick J. Stiff, MD · Loyola University

  • Scott E. Smith, MD, PhD, FACP · Loyola University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-07-31
Primary Completion
2008-01-31
Completion
2011-12-31

Countries

  • United States

Study Locations

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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 NCT00121186 on ClinicalTrials.gov