Using Fludarabine and Melphalan Conditioning Regimen for CLL,Lymphoma,Multiple Myeloma (Flu-Mel)

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

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

Study Overview

• Status: Completed
• Conditions: Lymphoma; Multiple Myeloma; Chronic Lymphocytic Leukemia
• Intervention / Treatment: Drug: Flu-Mel

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.

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 138-736
    • Asan Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.; Other Names: Fludara-Alkaran

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	9years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
include tumor response, incidence of chronic GVHD, and immune reconstitution.	-The secondary objectives include tumor response, incidence of chronic GVHD, and immune reconstitution.	9years

Collaborators and Investigators

• Sponsor: Cooperative Study Group A for Hematology
• Investigators: Principal Investigator: Je-Hwan Lee, Doctor, COSAH

Publications and helpful links

General Publications

• 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.

Helpful Links

• Flu-Mel

Study record dates

Study Major Dates

• Study Start: July 1, 2001
• Primary Completion (Actual): September 1, 2010
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: October 5, 2008
• First Submitted That Met QC Criteria: October 12, 2008
• First Posted (Estimate): October 15, 2008

Study Record Updates

• Last Update Posted (Estimate): February 17, 2011
• Last Update Submitted That Met QC Criteria: February 16, 2011
• Last Verified: February 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Leukemia, B-Cell; Lymphoma; Multiple Myeloma; Neoplasms, Plasma Cell; Leukemia; Leukemia, Lymphocytic, Chronic, B-Cell; Leukemia, Lymphoid
• Other Study ID Numbers: C-001