At a glance
ClinicalIndex Comparison Record- ✓Age 50–75 years, or age 18–49 with prior HCT or not in first remission/chronic phase or high-risk medical conditions (heart/kidney disease)
- ✓Hematologic cancer patients must have received at least one prior course of chemotherapy or biological therapy (not treatment-naïve)
- ✓Availability of a healthy related or unrelated allogeneic donor
- ✕Eligible for another study or standard-of-care treatment offering higher cure probability or long-term disease control
- ✕Severe abnormal organ function (heart, kidneys, liver)
- ✕Untreated or progressive central nervous system (CNS) involvement by disease
- ✕Pregnancy or breast-feeding
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Study of Reduced-Intensity Allogeneic Peripheral Blood Stem Cell Transplantation (PBSCT) for Treatment of Hematologic Malignancies and Hematopoietic Failure States
In Brief
A Phase 2 clinical trial evaluating busulfan, and melphalan, and alemtuzumab for Hematologic Neoplasms and 4 related conditions. Completed, enrolled 16 participants across 1 site.
Detailed Summary
The purpose of this study is to look at whether the combination of lower-dose chemotherapy with two chemotherapy (anti-cancer) drugs, called busulfan and melphalan, and an antibody medication called alemtuzumab (Campath®), can prevent rejection of donor blood stem cells so that those cells take hold and build a healthy new blood cell factory after transplant. The study will also look at the safety of the combination of drugs and of the transplant of peripheral blood stem cells from a healthy relative or an unrelated donor.
Study Details
Timeline
Interventions
intravenous busulfan 3.2 mg/kg/dose daily for 2 days, on days -5 and -4 (i.e., 5 and 4 days, respectively, before PBSCT). intravenous melphalan 100 mg/m2 on day -3. intravenous alemtuzumab 30 mg/dose for 2 days, on days -2 and -1.