At a glance
ClinicalIndex Comparison Record- ✓Patient must be ineligible for conventional transplants and have disease expected to be stable for at least 100 days without chemotherapy
- ✓AML or ALL must have <5% marrow blasts at time of transplant
- ✓CLL must have failed 2 lines of conventional therapy and be refractory to fludarabine
- ✓Patient and donor must be matched for at least one DRB1 allele and one DQB1 allele
- ✕Positive crossmatch between donor and recipient
- ✕Life expectancy severely limited by non-malignancy disease
- ✕CNS involvement refractory to intrathecal chemotherapy
- ✕Presence of circulating leukemic blasts in peripheral blood for AML, ALL, or CML
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Campath (Alemtuzumab) Dose Escalation, Low-Dose TBI and Fludarabine Followed by HLA Class II Mismatched Donor Stem Cell Transplantation for Patients With Hematologic Malignancies: A Multicenter Trial
In Brief
A Phase 2 clinical trial evaluating alemtuzumab, total-body irradiation, and 7 other interventions for Acute Undifferentiated Leukemia and 63 related conditions. Completed, enrolled 12 participants across 2 sites in 2 countries.
Detailed Summary
This phase II trial is studying the side effects and best dose of alemtuzumab when given together with fludarabine phosphate and total-body irradiation followed by cyclosporine and mycophenolate mofetil in treating patients who are undergoing a donor stem cell transplant for hematologic cancer. Giving low doses of chemotherapy, such as fludarabine phosphate, a monoclonal antibody, such as alemtuzumab, and radiation therapy before a donor stem cell transplant helps stop the growth of cancer cells. Giving chemotherapy or radiation therapy before or after transplant also stops the patient's immune system from rejecting the donor's bone marrow stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine and mycophenolate mofetil after the transplant may stop this from happening.
Study Details
Timeline
Interventions
Given IV
Undergo low-dose TBI
Given IV
Given PO or IV
Given PO
Undergo allogeneic stem cell transplantation
Undergo PBSCT
Undergo GVHD prophylaxis/therapy
Correlative studies