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T-Cell Depleted Allogeneic Stem Cell Transplantation for Patients With Hematologic Malignancies

NCT00683046 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 204

Last updated 2016-11-22

Study results available
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Summary

Objectives:

1. To evaluate disease free survival after Campath 1H-based in vivo T-cell depletion and non-myelo-ablative ablative stem cell transplantation in patients with hematologic malignancies.
2. To evaluate the incidence and severity of acute and chronic GVHD after Campath 1H-based in vivo T-cell depletion, in patients with hematologic malignancies undergoing non-myelo-ablative stem cell transplantation.
3. To evaluate engraftment and chimerism after Campath 1H-based in vivo T-cell depletion and non-myelo-ablative ablative stem cell transplantation in patients with hematologic malignancies.

Conditions

Interventions

DRUG

Fludarabine

Fludarabine 30 mg/m2 intravenously daily at the same time over 30 minutes on days -7,-6,-5,4,-3,.

DRUG

Melphalan

Melphalan 140 mg/m2 IV on day -2.

DRUG

Stem cells

Stem cell infusion on day 0.

DRUG

Campath

Campath, 20 mg IV on day -7, 6, -5, -4, and -3.

Sponsors & Collaborators

  • University of Chicago

    lead OTHER

Principal Investigators

  • Andrew Artz, MD · University of Chicago

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-11-30
Primary Completion
2014-12-31
Completion
2014-12-31

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 NCT00683046 on ClinicalTrials.gov