Using Fludarabine and Melphalan Conditioning Regimen for CLL,Lymphoma,Multiple Myeloma - Full Text View

Sponsored by:	Cooperative Study Group A for Hematology
Information provided by:	Cooperative Study Group A for Hematology
ClinicalTrials.gov Identifier:	NCT00772811

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: Fludarabine, Melphalan	Phase II

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood Lymphoma Multiple Myeloma

Drug Information available for: Melphalan Fludarabine Fludarabine monophosphate Melphalan hydrochloride Sarcolysin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	Allogeneic Non-Myeloablative Stem Cell Transplantation Using Fludarabine and Melphalan Conditioning Regimen for Chronic Lymphocytic Leukemia, Lymphoma, and Multiple Myeloma

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: 2009 ] [ Designated as safety issue: No ]

Estimated Enrollment:	25
Study Start Date:	June 2001
Estimated Study Completion Date:	December 2009
Primary Completion Date:	July 2001 (Final data collection date for primary outcome measure)

Intervention Details:

Fludarabine 30mg/m2/day, Melphalan 100mg/m2

Detailed Description:

1.1 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.

1.2 The secondary objectives include tumor response, incidence of chronic GVHD, and immune reconstitution.

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.

Exclusion Criteria:

Patients with high serum creatinine level will be excluded.
Patients should have uncontrolled infection.

Contacts and Locations

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

Contacts

Contact: Yae-Eun Jang, Nurse

82-2-3010-7290

redpin75@paran.com

Locations

Korea, Republic of
Asan Medical Center	Recruiting
Seoul, Korea, Republic of, 138-736
Contact: Yae-Eun Jang, Nurse

Sponsors and Collaborators

Cooperative Study Group A for Hematology

Investigators

Principal Investigator:

Kyoo-Hyung Lee, Doctor

COSAH

More Information

Responsible Party:	Asan Medical Center ( Kyoo-Hyung Lee )
Study ID Numbers:	C-001
Study First Received:	October 5, 2008
Last Updated:	October 12, 2008
ClinicalTrials.gov Identifier:	NCT00772811
Health Authority:	Korea: Food and Drug Administration

Study placed in the following topic categories:

Chronic lymphocytic leukemia
Melphalan
Leukemia, Lymphoid
Immunoproliferative Disorders
Hematologic Diseases
Blood Protein Disorders
Leukemia, B-cell, chronic
Blood Coagulation Disorders
Vascular Diseases
Paraproteinemias
Fludarabine monophosphate
Hemostatic Disorders

Multiple Myeloma
Leukemia
Lymphatic Diseases
Hemorrhagic Disorders
Multiple myeloma
Leukemia, Lymphocytic, Chronic, B-Cell
Fludarabine
Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphoma
Neoplasms, Plasma Cell

Additional relevant MeSH terms:

Antimetabolites
Antimetabolites, Antineoplastic
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs

Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Therapeutic Uses
Myeloablative Agonists
Cardiovascular Diseases
Antineoplastic Agents, Alkylating
Alkylating Agents

ClinicalTrials.gov processed this record on January 14, 2009