NCT00772811

Using Fludarabine and Melphalan Conditioning Regimen for CLL,Lymphoma,Multiple Myeloma

Allogeneic Non-Myeloablative Stem Cell Transplantation Using Fludarabine and Melphalan Conditioning Regimen for Chronic Lymphocytic Leukemia, Lymphoma, and Multiple Myeloma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Cooperative Study Group A for Hematology · Network
• Sex: All
• Age: 15 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Allogeneic Non-Myeloablative Stem Cell Transplantation Using Fludarabine and Melphalan Conditioning Regimen for Chronic Lymphocytic Leukemia, Lymphoma, and Multiple Myeloma

Detailed description

Treatment plan * 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 -2. * 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.

Conditions

• Chronic Lymphocytic Leukemia
• Lymphoma
• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Flu-Mel	* 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 -2.

Timeline

• Start date: 2001-07-01
• Primary completion: 2010-09-01
• Completion: 2010-12-01
• First posted: 2008-10-15
• Last updated: 2011-02-17

Locations

1 site across 1 country: South Korea