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Autologous Stem Cell Transplants for Chronic Myelogenous Leukemia

This study has been terminated.
(Terminated due to low accrual.)
Sponsor:
Collaborator:
Information provided by:
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00446173
First received: March 9, 2007
Last updated: October 5, 2009
Last verified: September 2009
  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: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]
  • Survival Time [ Time Frame: 30 Days (Success Rate + ANC Recovery to 500) ] [ Designated as safety issue: No ]

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

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
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, see Learn About Clinical Studies.

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

Locations
United States, Texas
U.T. M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Marcos de Lima, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

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
Study First Received: March 9, 2007
Results First Received: September 1, 2009
Last Updated: October 5, 2009
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

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

ClinicalTrials.gov processed this record on November 24, 2014