Autologous Stem Cell Transplants for Chronic Myelogenous Leukemia - Full Text View

Sponsors and Collaborators:	M.D. Anderson Cancer Center National Cancer Institute (NCI)
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00446173

Purpose

Primary Objective:

1. To study ex-vivo purging of autologous hematopoietic stem cells that will be used to support high-dose chemotherapy in patients with chronic myelogenous leukemia (CML). Major endpoints are neutrophil engraftment and survival.

Secondary Objectives:

To evaluate the toxicity of ex-vivo purged autologous cells when used to support high-dose chemotherapy.
To evaluate the rate and duration of cytogenetic remissions achieved with this strategy.
To determine the time to platelet recovery to 20,000/mm3.
To determine the one-year survival rate.

Condition	Intervention	Phase
Leukemia	Drug: Busulfan Drug: Cyclophosphamide Drug: G-CSF Drug: GM-CSF	Phase II

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic

Drug Information available for: Cyclophosphamide Filgrastim Sargramostim Granulocyte-macrophage colony-stimulating factor Granulocyte colony-stimulating factor Busulfan

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Autologous Purged Hematopoietic Stem Cell Transplantation for Chronic Myelogenous Leukemia (CML)

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

To look at a method of purging (cleaning) autologous hematopoietic stem cells (blood forming cells) that are collected from patients with CML. [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
To evaluate the side effects caused by infusing the cells that are treated in the laboratory back into the patient. [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
To learn how long it takes for the cells to produce elements of the blood (white cells, red cells, and platelets) and the ability of this treatment to cause the CML to go into remission. [ Time Frame: 2 Years ] [ Designated as safety issue: No ]

Estimated Enrollment:	48
Study Start Date:	March 2007
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Busulfan + Cyclophosphamide + G-CSF + GM-CSF	Drug: Busulfan 130 mg/m^2 IV Daily Over 3 Hours x 4 Days Drug: Cyclophosphamide 60 mg/kg IV Daily Over 4 Hours x 2 Days Drug: G-CSF 10 mcg/kg Subcutaneously Once Daily Drug: GM-CSF 250 mcg/kg Subcutaneously Once Daily

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Eligibility

Ages Eligible for Study:	21 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with Philadelphia (Ph) chromosome positive CML < age 65 and older than 21 years.
Ph positive CML that is either in: 1. late 1st chronic phase (> 2 years from diagnosis) 2. early chronic phase who did not achieve complete cytogenetic remission after one year on imatinib 3. beyond first chronic phase 4. accelerated phase 5. blastic phase that has responded to therapy (characterized by the presence of < 10% bone marrow and/or circulating blasts at consent signing) 6. chronic phase, developing imatinib resistance (loss of molecular remission defined as at least a 1 log increase in the BCR-ABL/ABL ratio, in 2 time points at least 1 month apart, or loss of cytogenetic remission)
Patients must have a Zubrod PS < 3. Creatinine < 1.8 mg/dl
Serum bilirubin </= 1.5 mg/dl
SGPT < 3 x normal values
Patients with an HLA identical sibling are eligible if they refuse allogeneic transplantation, or if they are ineligible for allogeneic transplantation due to age.
DLCO >/= 50% of predicted
Cardiac Ejection fraction >/= 40%

Exclusion Criteria:

Uncontrolled life-threatening infections or comorbid condition that could impair tolerance to the regimen.
HIV positivity.
Pregnant or lactating women.
CML in blastic phase that has not responded to therapy given prior to enrollment in this study (characterized by the presence of more than 9% bone marrow and/or peripheral blood blasts at the time of consent signing)
Hepatitis B or C virus infection. Hepatitis B infection defined by positive DNA test, positive E and / or surface antigen.
CML in first molecular remission.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00446173

Contacts

Contact: Marcos de Lima, MD

713-792-8750

Locations

United States, Texas
U.T. M.D. Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Marcos de Lima, MD

Sponsors and Collaborators

M.D. Anderson Cancer Center

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Marcos de Lima, MD

U.T.M.D. Anderson Cancer Center

More Information

UT MD Anderson Cancer Center This link exits the ClinicalTrials.gov site

Responsible Party:	U.T.M.D. Anderson Cancer Center ( Marcos de Lima, MD/Associate Professor )
Study ID Numbers:	2003-0710
Study First Received:	March 9, 2007
Last Updated:	October 24, 2008
ClinicalTrials.gov Identifier:	NCT00446173
Health Authority:	United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:

Chronic Myelogenous Leukemia
Leukemia
Philadelphia (Ph) chromosome positive CML
Busulfan
Busulfex
Myleran
Cyclophosphamide
Cytoxan

Neosar
G-CSF
Filgrastim
Neupogen
GM-CSF
Sargramostim
Leukine

Study placed in the following topic categories:

Leukemia
Chronic myelogenous leukemia
Hematologic Diseases
Busulfan
Myeloproliferative Disorders

Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Cyclophosphamide
Leukemia, Myeloid
Bone Marrow Diseases

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions

Neoplasms
Therapeutic Uses
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Alkylating Agents

ClinicalTrials.gov processed this record on January 16, 2009