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

The University of Chicago

Status and phase

Completed

Phase 2

Conditions

Acute Myelogenous Leukemia

Anemia, Aplastic

Malignant Lymphoma

Hodgkin's Disease

Chronic Myelogenous Leukemia

Chronic Lymphocytic Leukemia

Myelodysplastic Syndromes

Lymphoid Leukemia

Myeloproliferative Disorder

Treatments

Drug: Melphalan

Drug: Fludarabine

Drug: Stem cells

Drug: Campath

Study type

Interventional

Funder types

Other

Identifiers

11300A

Details and patient eligibility

About

Objectives:

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.
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.
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.

Enrollment

204 patients

Sex

All

Ages

Under 100 years old

Volunteers

No Healthy Volunteers

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.