Using Fludarabine and Melphalan Conditioning Regimen for CLL,Lymphoma,Multiple Myeloma
- Conditions
- Chronic Lymphocytic LeukemiaLymphomaMultiple Myeloma
- Interventions
- Drug: Flu-Mel
- Registration Number
- NCT00772811
- Lead Sponsor
- Cooperative Study Group A for Hematology
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 38
- Patients must be 15 years of age or older and 65 years of age or younger
- Patients with CLL, lymphoma, or multiple myeloma will be included in this study
- No prior anti-cancer treatment should be done within 30 days.
- Informed consent should be given.
- Patients should have an HLA-identical or single HLA-locus mismatched donor.
- Karnofsky performance scale should be 50 or over (see Appendix I).
- Patients must not have a psychiatric disorder or mental deficiency severe as to make compliance with the stem cell transplant treatment unlike, and making informed consent impossible.
- Patients with high serum creatinine level will be excluded.
- Patients should have uncontrolled infection.
- No major anticipated illness or organ failure incompatible with survival from stem cell transplant.
- Serum bilirubin less than or equal to 4.0 mg/dL.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Flu-Mel 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.
- Primary Outcome Measures
Name Time Method To evaluate engraftment, chimerism, toxicity, incidence of acute graft-versus-host disease (GVHD), and day 100 treatment-related mortality (TRM) 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.
- Secondary Outcome Measures
Name Time Method include tumor response, incidence of chronic GVHD, and immune reconstitution. 9years -The secondary objectives include tumor response, incidence of chronic GVHD, and immune reconstitution.
Trial Locations
- Locations (1)
Asan Medical Center
🇰🇷Seoul, Korea, Republic of