At a glance
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A Phase II Study of Sirolimus, Tacrolimus and Thymoglobulin, as Graft-versus-Host Prophylaxis in Patients Undergoing Unrelated Donor Hematopoietic Cell Transplantation
In Brief
A Phase 2 clinical trial evaluating anti-thymocyte globulin, cyclophosphamide, and 11 other interventions for Chronic Myeloproliferative Disorders and 10 related conditions. Completed, enrolled 32 participants across 2 sites.
Detailed Summary
RATIONALE: Giving chemotherapy and total-body irradiation before a donor 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 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 tacrolimus, sirolimus, antithymocyte globulin, and methotrexate before and after transplant may stop this from happening. PURPOSE: This phase II trial is studying how well sirolimus, tacrolimus, and antithymocyte globulin work in preventing graft-versus-host disease in patients undergoing a donor stem cell transplant for hematological cancer .
Study Details
Timeline
Interventions
0.5 mg/kg on day -3, 1.5 mg/kg on day -2 and 2.5 mg/kg on day -1 or day 0 from stem cell transplant
60mg/kg on days -5 and -4 from stem cell transplant
60mg/kg on day -4 from stem cell transplant
Fludarabine 25 mg/m2/d from days -9 to -5 from stem cell transplant
Melphalan 140 mg/m2 on day -4 from stem cell transplant
For high risk HLA-mismatch transplant only: 5 mg/m2 on days +1, +3 and +6 from stem cell transplant
Adults: 12 mg loading dose on day -3 from stem cell transplant followed by 4 mg orally single morning daily dose. Pediatric Patients \<40kg: 3 mg/m2 orally on day -3 from stem cell transplant followed by 1 mg/m2 orally single morning daily dose
0.02 mg/kd/d CIV beginning on day -3 from stem cell transplant
The target peripheral blood stem cell dose will be 5-10 x 106/kg actual body weight
The target peripheral blood stem cell dose will be 5-10 x 106/kg actual body weight
Fludarabine 25 mg/m2/d from days -9 to -5 from stem cell transplant, Melphalan 140 mg/m2 on day -4 from stem cell transplant
The target peripheral blood stem cell dose will be 5-10 x 106/kg actual body weight
1320 cGy in 11 fractions from day -8 to day -5 or day -9 to day -6 prior to stem cell transplant