At a glance
ClinicalIndex Comparison Record- ✓Relapsed or primary refractory non-Hodgkin lymphoma with chemo/radiosensitive or non-progressive disease, or disease in marrow ineligible for autologous transplant
- ✓Chemosensitive relapsed or refractory acute and chronic lymphocytic leukemias
- ✓Relapsed or primary refractory Hodgkin Disease
- ✓Advanced (Durie-Salmon stage II or III) multiple myeloma or advanced Waldenstrom macroglobulinemia
- ✕Pregnant or lactating females
- ✕Active or uncontrolled viral (including HIV-1), bacterial, or fungal infection
- ✕Severe renal insufficiency (creatinine >2.0 or creatinine clearance <30 mL/minute)
- ✕Severe hepatic dysfunction (total bilirubin >2.5 mg/dL and AST and ALT >3× normal) unless liver involved with disease
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase II Trial Of Non-Myeloablative Regimen Combining Melphalan, Fludarabine, And Anti-CD52 Monoclonal Antibody (CAMPATH-1H) Followed By An Unmodified Hematopoietic Cell Transplant From An HLA Compatible Related Or Unrelated Donor For Treatment Of Lymphohematopoietic Malignancies
In Brief
A Phase 2 clinical trial evaluating alemtuzumab, cyclosporine, and 4 other interventions for Leukemia and 4 related conditions. Completed, enrolled 51 participants across 1 site.
Detailed Summary
RATIONALE: Giving low doses of chemotherapy, such as melphalan and fludarabine, and a monoclonal antibody, such as alemtuzumab, before a donor bone marrow or peripheral blood stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system 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 after the transplant may stop this from happening. PURPOSE: This phase II trial is studying how well fludarabine, melphalan, alemtuzumab, and peripheral stem cell transplant work in treating patients with hematologic cancer.
Study Details
Timeline
Interventions
Consenting individuals will receive pretransplant immunosuppressive cytoreduction, which will consist of 4 days of Campath-1H, 5 days of fludarabine, and two days of melphalan. All therapy should be completed approximately 24-36 hours before administration of the primary allograft. Campath-1H (20mg/dose/day) will be administered for each of four days from day -8 to day -5, inclusive. Each dose will be infused intravenously over 8 hours.
Patients will be treated with Cyclosporine as prophylaxis against GvHD. Cyclosporine will be initiated at least 1 day prior to transplant at a dose of 1.5 mg / kg IV q12h (3 mg / kg / day = total daily dose). Dose will thereafter be adjusted to maintain a trough serum level of 200-300 ng /ml. Cyclosporine will be administered intravenously until the patient tolerates full alimentation, at which time conversion to oral dosing to sustain therapeutic levels will be initiated according to standard BMT service guidelines.
Fludarabine, 25mg/m2/d will be administered for each of five days from day -8 to day -4, inclusive. Each dose will be infused intravenously over 30 minutes.
Melphalan will be administered intravenously over 30 minutes on each of two days from day -3 to day -2, inclusive. The dose for recipients of HLA-matched related grafts will be 50 mg/m2/day x 2. The dose for recipients of HLA-matched unrelated and HLA-single allele disparate related or unrelated marrow or PBSC transplants will be 70 mg/m2/day x 2.