Allogeneic Non-Myeloablative Stem Cell Transplantation Using Fludarabine and Melphalan Conditioning Regimen for Chronic Lymphocytic Leukemia, Lymphoma, and Multiple Myeloma
- Conditioning chemotherapy before infusion of allogeneic stem cells will include
fludarabine 30 mg/m2/day for 5 consecutive days (days -6 to -2) and melphalan 100 mg/m2
at day -2.
- Fludarabine and Melphalan will be infused intravenously over 30 minutes in D5W 100 mL.
- Melphalan will be administered following the completion of Fludarabine infusion at day
- In case of unrelated donor HCT, thymoglobuline 3 mg/kg in N/S 500 mL (less than 0.5
mg/mL) or lymphoglobuline 15 mg/kg in N/S 500 mL (less than 2 mg/mL) IV qd on days -4,
-3 and -2. Infuse over 4 hrs. Premedicate with Avil 45.5 mg IVP and Tylenol 600 mg po.
Methylprednisolone 2 mg/kg in D5W 100 ml will be given IV over 30 minutes before
thymoglobulin (or lymphoglobuline) on days -4 to -2.
- Before the administration of melphalan, prehydration will be done intravenously with
0.9% NS 1L over 3 hours.
- 30 minutes before melphalan infusion, premedication with dexamethasone 10 mg and ativan
1 mg i.v. push will be given. Appropriate antiemetics such as ondansetron 8 mg i.v.
push every 4-6 hours and ativan 1-2 mg i.v. push every 4-6 hours will be administered.
- Hydration with 0.9% NS at 80 mL/hour will be administered for at least 7 days.
Appropriate amount of KCl should be mixed.
- GVHD prophylaxis will include cyclosporine A (CSA) and methotrexate.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To evaluate engraftment, chimerism, toxicity, incidence of acute graft-versus-host disease (GVHD), and day 100 treatment-related mortality (TRM)
-To evaluate engraftment, chimerism, toxicity, incidence of acute graft-versus-host disease (GVHD), and day 100 treatment-related mortality (TRM) following allogeneic nonmyeloablative stem cell transplantation using fludarabine and melphalan conditioning regimen in patients with chronic lymphocytic leukemia (CLL), lymphoma, and multiple myeloma.
Je-Hwan Lee, Doctor
Korea: Food and Drug Administration