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Alemtuzumab and Combination Chemotherapy Followed By Donor Lymphocytes in Treating Patients Who Are Undergoing Donor Stem Cell Transplant for Hematologic Cancer

NCT00104975 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2016-12-15

No results posted yet for this study

Summary

RATIONALE: Giving low doses of chemotherapy before a donor 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). Giving an infusion of the donor's T cells that have been treated in the laboratory after the transplant may help increase this effect. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving tacrolimus before and after transplant may stop this from happening.

PURPOSE: This phase I trial is studying the side effects and best dose of donor lymphocytes when given after alemtuzumab and combination chemotherapy in treating patients who are undergoing donor stem cell transplant for hematologic cancer.

Conditions

Interventions

BIOLOGICAL

alemtuzumab

BIOLOGICAL

therapeutic allogeneic lymphocytes

DRUG

fludarabine phosphate

DRUG

melphalan

DRUG

tacrolimus

DRUG

thiotepa

PROCEDURE

peripheral blood stem cell transplantation

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Yale University

    lead OTHER

Principal Investigators

  • Erkut Bahceci, MD · Yale University

Study Design

Purpose
TREATMENT

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-02-28
Primary Completion
2008-05-31
Completion
2008-05-31

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 NCT00104975 on ClinicalTrials.gov