Overview

This trial is active, not recruiting.

Conditions acute myelogenous leukemia, lymphoid leukemia, chronic myelogenous leukemia, malignant lymphoma, hodgkin's disease, chronic lymphocytic leukemia, myeloproliferative disorder, anemia, aplastic, myelodysplastic syndromes
Treatments fludarabine, melphalan, stem cells, campath
Phase phase 2
Target CD52
Sponsor University of Chicago
Start date November 2001
End date December 2013
Trial size 204 participants
Trial identifier NCT00683046, 11300A

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Measure
Median Disease-free Survival
time frame: 10 years

Secondary Outcomes

Measure
Median Overall Survival
time frame: 10 years

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: - Zubrod performance status 2 (See Appendix B). - Life expectancy is not severely limited by concomitant illness. - Adequate cardiac and pulmonary function. Patients with decreased LVEF or PFTS will be evaluated by cardiology or pulmonary prior to enrollment on this protocol. - Serum creatinine <1.5 mg/dL or Creatinine Clearance >50 ml/min . - Serum bilirubin 2.0 mg/dl, SGPT <3 x upper limit of normal - No evidence of chronic active hepatitis or cirrhosis. - HIV-negative - Patient is not pregnant - Patient or guardian able to sign informed consent. Exclusion Criteria: - N/A

Additional Information

Official title T-Cell Depleted Allogeneic Stem Cell Transplantation for Patients With Hematologic Malignancies
Principal investigator Andrew Artz, MD
Trial information was received from ClinicalTrials.gov and was last updated in February 2014.
Information provided to ClinicalTrials.gov by University of Chicago.