Clinical trial NCT00772811: Using Fludarabine and Melphalan Conditioning Regimen for CLL,Lymphoma,Multiple Myeloma
Official title: Allogeneic Non-Myeloablative Stem Cell Transplantation Using Fludarabine and Melphalan Conditioning Regimen for Chronic Lymphocytic Leukemia, Lymphoma, and Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Lymphocytic Leukemia
Lymphoma
Multiple Myeloma
Lead sponsor: Cooperative Study Group A for Hematology
Sponsor class: NETWORK
First posted: 2008-10-15
Enrollment: 38
Sex: ALL
Minimum age (years): 15
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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.

Primary outcomes:
measure: To evaluate engraftment, chimerism, toxicity, incidence of acute graft-versus-host disease (GVHD), and day 100 treatment-related mortality (TRM)
timeFrame: 9years
Secondary outcomes:
measure: include tumor response, incidence of chronic GVHD, and immune reconstitution.
timeFrame: 9years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: COSAH
name: Je-Hwan Lee, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lee JH, Lee JH, Kim DY, Seol M, Lee YS, Kang YA, Jeon M, Lee KH. A Phase II Trial of Fludarabine/Melphalan 100 Conditioning Therapy Followed by Allogeneic Hematopoietic Cell Transplantation for Patients With Lymphoma. Clin Lymphoma Myeloma Leuk. 2015 Nov;15(11):655-63. doi: 10.1016/j.clml.2015.08.087. Epub 2015 Sep 3.