TerminatedInterventionalPhase 2Updated Oct 10, 2012
T-Cell Depleted Allogeneic Stem Cell Transplantation for Patients With Hematologic Malignancies | NCT00683046 | Trialant
CompletedInterventionalPhase 2Updated Nov 22, 2016
T-Cell Depleted Allogeneic Stem Cell Transplantation for Patients With Hematologic Malignancies
T-Cell Depleted Allogeneic Stem Cell Transplantation for Patients With Hematologic Malignancies
ClinicalTrials.gov ID
NCT00683046
Lead Sponsor
University of ChicagoOTHER
Overall Status
Completed
Study Type
Interventional
Phase
Phase 2
Enrollment
204Actual
Last Update Posted
Nov 22, 2016Estimated
Start Date
Nov 2001
Primary Completion Date
Dec 2014Actual
Completion Date
Dec 2014Actual
Official Title
T-Cell Depleted Allogeneic Stem Cell Transplantation for Patients With Hematologic Malignancies
Brief Summary
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.
Acute Myelogenous Leukemia
Lymphoid Leukemia
Chronic Myelogenous Leukemia
Malignant Lymphoma
Hodgkin's Disease
Chronic Lymphocytic Leukemia
Myeloproliferative Disorder
Anemia, Aplastic
Myelodysplastic Syndromes
Fludarabine
Melphalan
Stem cells
Campath
Ages Eligible for Study
Child (0-17)Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility 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.