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Imatinib Mesylate, Busulfan, Fludarabine, Antithymocyte Globulin and Allogeneic Stem Cell Transplantation for Chronic Myelogenous Leukemia

Phase 2
70 Years
Not Enrolling

Thank you

Trial Information

Imatinib Mesylate, Busulfan, Fludarabine, Antithymocyte Globulin and Allogeneic Stem Cell Transplantation for Chronic Myelogenous Leukemia

Patients will have blood and bone marrow tests performed as well as chest and sinus X-rays
and tests of their heart and lung function. Approximately 5 tablespoons of blood will be

All patients in this study will receive imatinib mesylate by mouth for 9 days, unless the
patient is known to be allergic or have symptomatic intolerance to the drug, or if the
leukemia has failed to respond to imatinib. Fludarabine 40 mg/m2 by vein for 4 days (days
-5 to -2), busulfan 130 mg/m2 by vein for 2 days (days -3 and -2), and ATG (Antithymocyte
Globulin) 2.5 mg/kg by vein for 3 days (-3,-2 and -1).

Patients will then receive the donor bone marrow or blood stem cells by vein over
approximately one hour on day 0.

After the infusion of the donor cells, you will receive immunosuppressive therapy with
tacrolimus and methotrexate to decrease the risk of developing graft-vs-host disease (GvHD).

Patients will need frequent blood tests to monitor their counts and blood chemistries. This
is generally done daily while in hospital and at least twice per week for the first 100 days
post transplant. You may need frequent blood transfusions and may have to be admitted to
the hospital to receive antibiotics if they develop fever. Bone marrow will be examined
frequently beginning four weeks after treatment to evaluate response to treatment; Blood and
bone marrow exams are to be performed at one, two three, six, 12 and 18 months post
transplant and yearly thereafter for 5 years. To collect a bone marrow sample, an area of
the hip or chest bone is numbed with anesthetic and a small amount of bone marrow is
withdrawn through a large needle.

Patients in whom treatment produces a remission, in which no sign of the leukemia can be
detected, will receive no further therapy unless the leukemia recurs. Patients with
evidence of leukemia after 3 months from the transplant will receive additional treatment
with imatinib mesylate; those with detectable leukemia after an additional 3 months may
receive an infusion of immune cells from the transplant donor.

If there is evidence of leukemia after the transplant, you will receive additional treatment
with imatinib mesylate. If leukemia cells can still be detected, additional donor immune
cells will be given to you by vein.

Patients are considered on the study for 5 years after the transplant.

A total of 90 patients will take part in this study. All will be enrolled at M. D.

Inclusion Criteria:

1. Diagnosis of Ph+ chronic myelogenous leukemia (CML) in first chronic phase without a
complete hematologic response after 3 months of Imatinib mesylate therapy, or >=35%
Ph+ cells despite > 6 months of Imatinib mesylate treatment, or after disease
progression from a complete or partial response. Any patient with accelerated phase
or blast crisis who achieves a subsequent chronic phase is eligible. Patients must
have an HLA matched related or unrelated donor or one antigen mismatched related

2. Patients should be less than 70 years of age. Patients less than 30 years of age who
achieve a hematologic remission with imatinib therapy are eligible regardless of
cytogenetic response.

3. Patients are stratified as Group 1: First chronic phase, Group 2 Accelerated phase or
blast crisis that achieved a hematologic remission with imatinib mesylate-based

Exclusion Criteria:

1. Zubrod Performance Scale (PS) >=2, uncontrolled infection, Creatinine > 2.0 mg/dl;
Ejection fraction < 40%; Carbon Monoxide Diffusing Capacity (DLCO) < 45% of
predicted; Serum bilirubin > 2 gm/dl; GPT (Glutamic-pyruvic transaminase) or GOT
(glutamic-oxaloacetic transaminase)> 3 times normal values. Patients should not be
human immunodeficiency virus (HIV) seropositive or pregnant.

2. Patients should not have progressed to accelerated phase or blast crisis while
receiving imatinib mesylate containing therapy.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Participants in Complete Molecular Remission at 1 Year

Outcome Description:

Participants at 1 year in molecular remission, post transplant, post imatinib mesylate and donor lymphocyte infusion (DLI). Molecular remission is a complete remission with no evidence of disease in the blood cells and/or bone marrow using sensitive polymerase chain reaction (PCR) tests (this test is most commonly used in clinical trials).

Outcome Time Frame:

Baseline to 1 year

Safety Issue:


Principal Investigator

Richard E. Champlin, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

February 2003

Completion Date:

November 2009

Related Keywords:

  • Leukemia
  • Chronic Myelogenous Leukemia
  • Allogeneic Stem Cell Transplantation
  • Leukemia
  • Imatinib Mesylate
  • Gleevec
  • Busulfan
  • Busulfex
  • Myleran
  • Fludarabine
  • ATG
  • STI571
  • Antithymocyte Globulin
  • Thymoglobulin
  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive



UT MD Anderson Cancer CenterHouston, Texas  77030