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Autologous Stem Cell Transplants for Chronic Myelogenous Leukemia

This study has been withdrawn prior to enrollment.
(Terminated due to low accrual.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00446173
First Posted: March 12, 2007
Last Update Posted: August 25, 2015
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.
Collaborator:
National Cancer Institute (NCI)
Information provided by:
M.D. Anderson Cancer Center
  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:

  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 Intervention Phase
Leukemia Drug: Busulfan Drug: Cyclophosphamide Drug: G-CSF Drug: GM-CSF Phase 2

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:


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

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

Enrollment: 0
Study Start Date: March 2007
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
  • 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.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00446173


Locations
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)
Investigators
Principal Investigator: Marcos de Lima, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
Responsible Party: Marcos de Lima, MD/Associate Professor, U.T.M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00446173     History of Changes
Other Study ID Numbers: 2003-0710
First Submitted: March 9, 2007
First Posted: March 12, 2007
Last Update Posted: August 25, 2015
Last Verified: August 2015

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

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Cyclophosphamide
Busulfan
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists