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

This study has been completed.
Sponsor:
Information provided by:
Cooperative Study Group A for Hematology
ClinicalTrials.gov Identifier:
NCT00772811
First received: October 5, 2008
Last updated: February 16, 2011
Last verified: February 2011
  Purpose

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


Condition Intervention Phase
Chronic Lymphocytic Leukemia
Lymphoma
Multiple Myeloma
Drug: Flu-Mel
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Allogeneic Non-Myeloablative Stem Cell Transplantation Using Fludarabine and Melphalan Conditioning Regimen for Chronic Lymphocytic Leukemia, Lymphoma, and Multiple Myeloma

Resource links provided by NLM:


Further study details as provided by Cooperative Study Group A for Hematology:

Primary Outcome Measures:
  • To evaluate engraftment, chimerism, toxicity, incidence of acute graft-versus-host disease (GVHD), and day 100 treatment-related mortality (TRM) [ Time Frame: 9years ] [ Designated as safety issue: No ]
    -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:
  • include tumor response, incidence of chronic GVHD, and immune reconstitution. [ Time Frame: 9years ] [ Designated as safety issue: No ]
    -The secondary objectives include tumor response, incidence of chronic GVHD, and immune reconstitution.


Enrollment: 38
Study Start Date: July 2001
Study Completion Date: December 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Fludara-Alkaran

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

Ages Eligible for Study:   15 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00772811

Locations
Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
Cooperative Study Group A for Hematology
Investigators
Principal Investigator: Je-Hwan Lee, Doctor COSAH
  More Information

Additional Information:
No publications provided

Responsible Party: Je-Hwan Lee, Asan Medical Center
ClinicalTrials.gov Identifier: NCT00772811     History of Changes
Other Study ID Numbers: C-001
Study First Received: October 5, 2008
Last Updated: February 16, 2011
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma
Leukemia
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Lymphatic Diseases
Leukemia, B-Cell
Fludarabine
Fludarabine phosphate
Melphalan
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents

ClinicalTrials.gov processed this record on September 18, 2014