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A Phase II Study of High-Dose Intravenous Busulfan and Fludarabine With Allogeneic Marrow and Peripheral Blood Progenitor Cell Transplantation for Acute Myeloid Leukemia and Myelodysplastic Syndromes


Phase 2
N/A
66 Years
Not Enrolling
Both
Leukemia

Thank you

Trial Information

A Phase II Study of High-Dose Intravenous Busulfan and Fludarabine With Allogeneic Marrow and Peripheral Blood Progenitor Cell Transplantation for Acute Myeloid Leukemia and Myelodysplastic Syndromes


Patients who agree to the optional pharmacology procedures #1 will initially receive a
therapeutic test dose of busulfan to test the blood levels over time; this information will
be used to determine the subsequent high-dose busulfan doses. Patients who do not agree to
the optional pharmacology procedure will receive a fixed dose of busulfan as has previously
been done for 3 years.

Patients in this study will then receive fludarabine through a central venous catheter over
one hour, once a day, for four days. High-dose Busulfan will be injected through the
catheter over three hours, once a day, for four days, starting immediately after
fludarabine.

After two days of rest, the allogeneic bone marrow, peripheral blood stem cells or cord
blood will then be given intravenously. Patients will receive the drug Granulocyte
colony-stimulating factor (G-CSF - Neupogen) as an injection under the skin until their
blood counts recover.

Patients will remain in the hospital for about 4-6 weeks. After discharge, patients will
continue as outpatients in the hospital area until they are able to safely leave the
immediate hospital area or for a minimum of 100 days after the transplant. Some patients may
need to receive spinal taps with instillation of cytosine arabinoside and hydrocortisone
several times over the year after transplantation. This is only for patients with a previous
clinical history of leukemic involvement of the brain.

This is an investigational study. The FDA has approved the study drugs. Up to 200 patients
will take part in this study. All will be enrolled at M. D. Anderson.


Inclusion Criteria:



1. Acute leukemia past first remission, in first or subsequent relapse, in first
remission (high-risk, i.e., cytogenetics other than t(8;21, inv 16, t(15;17)) or
induction failures.

2. Myelodysplastic syndromes in any clinical stage, excluding only patients who have
isolated stable mono-cytopenia and who are clinically stable.

3. Patient has not been administered any other systemic chemotherapeutic drug (including
Mylotarg) within 21 days prior to trial enrollment (BMT Day -7 or BMT day -9).
(Hydroxyurea and intrathecal chemotherapy is permitted).

4. No uncontrolled infection.

5. Patients up to age 65 will be eligible for this study.

6. ALLOGENEIC TRANSPLANTATION:

Patients should have an acceptable related or unrelated volunteer donor available for
a bone marrow peripheral blood progenitor cell or cord blood transplant. Bone marrow
and peripheral blood cell donors should be matched for at least 5 of 6 HLA A, B and
DR loci. Cord blood donors should be matched for at least 4 of 6 A, B and DR loci.

7. Life expectancy is not severely limited.

8. Pulmonary, cardio, renal and liver function tests normal.

9. In patients < 7 years pulmonary function will be assessed per pediatric BMT routine.

10. No evidence of chronic active hepatitis or cirrhosis.

11. HIV-negative.

12. Female patient is not pregnant

13. Signed informed consent.

14. Patient admitted on Sunday, or Monday to allow for pharmacokinetic directed therapy.

Exclusion Criteria:

1) Not fulfilling eligibility criteria above.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Number of Participants With Successful Engraftment

Outcome Description:

Successful Engraftment defined as first of 3 consecutive days with Absolute neutrophil count (ANC) equal to or more than 0.5 * 10^9/L. Failure to engraft by day +30 considered primary engraftment failure. Study period one week prior to transplant through post Day 28.

Outcome Time Frame:

Study period one week prior to transplant through post Day 28

Safety Issue:

No

Principal Investigator

Richard E. Champlin, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

ID01-011

NCT ID:

NCT00502905

Start Date:

October 2003

Completion Date:

November 2008

Related Keywords:

  • Leukemia
  • Acute Myeloid Leukemia
  • Myelodysplastic Syndromes
  • Busulfan
  • Busulfex
  • Myleran
  • Fludarabine
  • Fludarabine Phosphate
  • Fludara
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Myelodysplastic Syndromes
  • Preleukemia

Name

Location
U.T.M.D. Anderson Cancer Center Houston, Texas  77030