Phase 2
N=204
T-Cell Depleted Allogeneic Stem Cell Transplantation for Patients With Hematologic Malignancies
Acute Myelogenous Leukemia · Lymphoid Leukemia · Chronic Myelogenous Leukemia · Malignant Lymphoma · Hodgkin's Disease
Bottom Line
View on ClinicalTrials.gov: NCT00683046 ↗Enrolled (actual)
204
Serious AEs
33.8%
Results posted
Mar 2014
Primary outcome: Primary: Median Disease-free Survival — 333 Days
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Fludarabine (Drug); Melphalan (Drug); Stem cells (Drug); Campath (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- University of Chicago
- Primary completion
- Dec 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Median Disease-free Survival |
333 | — |
| SECONDARY Median Overall Survival |
547 | — |
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.
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 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
Data sourced from ClinicalTrials.gov (NCT00683046). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.