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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
History of Changes

October 5, 2008
February 16, 2011
July 2001
September 2010   (final data collection date for primary outcome measure)
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.
To evaluate engraftment, chimerism, toxicity, incidence of acute graft-versus-host disease (GVHD), and day 100 treatment-related mortality (TRM) [ Time Frame: 2009 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00772811 on ClinicalTrials.gov Archive Site
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.
Not Provided
Not Provided
Not Provided
 
Using Fludarabine and Melphalan Conditioning Regimen for CLL,Lymphoma,Multiple Myeloma
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

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.
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Chronic Lymphocytic Leukemia
  • Lymphoma
  • Multiple Myeloma
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
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.
Intervention: Drug: Flu-Mel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
38
December 2010
September 2010   (final data collection date for primary outcome measure)

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.
Both
15 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00772811
C-001
Yes
Je-Hwan Lee, Asan Medical Center
Cooperative Study Group A for Hematology
Not Provided
Principal Investigator: Je-Hwan Lee, Doctor COSAH
Cooperative Study Group A for Hematology
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP