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Megadose CD34 Selected Progenitor Cells for Transplantation in Patients With Advanced Hematological Malignant Diseases

NCT00038857 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2012-08-10

Study results available
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Summary

Donor:

This clinical study will evaluate the feasibility of a purified CD34 peripheral blood progenitor cell (PBPC) transplants in patients with hematological malignancies.

The primary objectives of the study are to evaluate the recipient obtaining donor derived neutrophil engraftment and the incidence of acute graft versus host disease \[GvHD\] (grade III-IV).

Secondary objectives include assessments of recipient having donor derived platelet engraftment, incidence of graft failure and chronic GvHD, overall and disease free survival, clinical safety and device performance of the CliniMACS CD34 selection device.

Conditions

Interventions

PROCEDURE

Megadose of CD34 Selected Progenitor Cells

Haploidentical peripheral blood progenitor cell (PBPC) transplants on Day 0.

DRUG

Melphalan

140 mg/m\^2 on day -8

DRUG

Thiotepa

10 mg/kg on day -7

DRUG

Fludarabine

160 mg/m\^2 over 4 days on days -6, -5, -4, -3

DRUG

Rabbit ATG

1.5 mg/kg of Rabbit ATG a day times 4 over 4 days on days -6, -5, -4, -3.

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Richard E. Champlin, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-09-30
Primary Completion
2009-06-30
Completion
2009-06-30

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 NCT00038857 on ClinicalTrials.gov