Stem Cell Transplant for Patients With Blood Malignancy Using Donors and Less Toxic Chemotherapy With CAMPATH 1H
NCT00048412 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2020-01-18
Summary
1. To assess the treatment related mortality of allogeneic stem cell transplantation with non-myeloablative therapy incorporating the lymphodepleting MAb CAMPATH-1H, in patients with hematological diseases and renal cell carcinoma not eligible for conventional (myeloablative) therapy.
2. To assess the time to engraftment and incidence of graft failure in patients receiving this transplant regimen.
3. To assess the safety, pharmacokinetics and immunologic activity of CAMPATH-1H when used as part of a subablative conditioning regimen.
Conditions
- Myelodysplastic Disorders
- Leukemia
- Multiple Myeloma
- Plasma Cell Dyscrasia
- Lymphoproliferative Disorders
Interventions
- DRUG
- DRUG
-
CAMPATH 1H
- DRUG
-
FK50
- PROCEDURE
-
Stem Cell Collection and Infusion
Sponsors & Collaborators
-
The Methodist Hospital Research Institute
collaborator OTHER -
Center for Cell and Gene Therapy, Baylor College of Medicine
collaborator OTHER -
Baylor College of Medicine
lead OTHER
Principal Investigators
-
George Carrum, MD · Baylor College of Medicine
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2000-06-30
- Primary Completion
- 2004-11-12
- Completion
- 2004-11-12
Countries
- United States
Study Locations
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