Using Fludarabine and Melphalan Conditioning Regimen for CLL,Lymphoma,Multiple Myeloma (Flu-Mel)
|ClinicalTrials.gov Identifier: NCT00772811|
Recruitment Status : Completed
First Posted : October 15, 2008
Last Update Posted : February 17, 2011
|Condition or disease||Intervention/treatment||Phase|
|Chronic Lymphocytic Leukemia Lymphoma Multiple Myeloma||Drug: Flu-Mel||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||38 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Allogeneic Non-Myeloablative Stem Cell Transplantation Using Fludarabine and Melphalan Conditioning Regimen for Chronic Lymphocytic Leukemia, Lymphoma, and Multiple Myeloma|
|Study Start Date :||July 2001|
|Actual Primary Completion Date :||September 2010|
|Actual Study Completion Date :||December 2010|
No Intervention: Flu-Mel
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.
Other Name: Fludara-Alkaran
- To evaluate engraftment, chimerism, toxicity, incidence of acute graft-versus-host disease (GVHD), and day 100 treatment-related mortality (TRM) [ Time Frame: 9years ]-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.
- include tumor response, incidence of chronic GVHD, and immune reconstitution. [ Time Frame: 9years ]-The secondary objectives include tumor response, incidence of chronic GVHD, and immune reconstitution.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00772811
|Korea, Republic of|
|Asan Medical Center|
|Seoul, Korea, Republic of, 138-736|
|Principal Investigator:||Je-Hwan Lee, Doctor||COSAH|