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

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Chicago
• Treatments: Alemtuzumab; Fludarabine; Fludarabine phosphate; Melphalan

Criteria

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