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Autologous Stem Cell Transplants for Chronic Myelogenous Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00446173
Recruitment Status : Withdrawn (Terminated due to low accrual.)
First Posted : March 12, 2007
Last Update Posted : August 25, 2015
National Cancer Institute (NCI)
Information provided by:
M.D. Anderson Cancer Center

Brief Summary:

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:

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

Condition or disease Intervention/treatment Phase
Leukemia Drug: Busulfan Drug: Cyclophosphamide Drug: G-CSF Drug: GM-CSF Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Autologous Purged Hematopoietic Stem Cell Transplantation for Chronic Myelogenous Leukemia (CML)
Study Start Date : March 2007
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 2009

Arm Intervention/treatment
Experimental: Busulfan + Cyclophosphamide + G-CSF + GM-CSF Drug: Busulfan
130 mg/m^2 IV Daily Over 3 Hours x 4 Days
Other Names:
  • Bulsulfex
  • Myleran

Drug: Cyclophosphamide
60 mg/kg IV Daily Over 4 Hours x 2 Days
Other Names:
  • Cytoxan
  • Neosar

Drug: G-CSF
10 mcg/kg Subcutaneously Once Daily
Other Names:
  • Filgrastin
  • Neupogen

Drug: GM-CSF
250 mcg/kg Subcutaneously Once Daily
Other Names:
  • Sargramostim
  • Leukine

Primary Outcome Measures :
  1. Time to absolute neutrophil count (ANC) recovery to 500 [ Time Frame: 30 Days ]
  2. Survival Time [ Time Frame: 30 Days (Success Rate + ANC Recovery to 500) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  • Serum glutamate pyruvate transaminase (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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00446173

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United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
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Principal Investigator: Marcos de Lima, MD M.D. Anderson Cancer Center

Additional Information:
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Responsible Party: Marcos de Lima, MD/Associate Professor, U.T.M.D. Anderson Cancer Center Identifier: NCT00446173     History of Changes
Other Study ID Numbers: 2003-0710
First Posted: March 12, 2007    Key Record Dates
Last Update Posted: August 25, 2015
Last Verified: August 2015
Keywords provided by M.D. Anderson Cancer Center:
Chronic Myelogenous Leukemia
Philadelphia (Ph) chromosome positive CML
Additional relevant MeSH terms:
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Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists