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Phase I/II Study of Pentostatin Combined With Tacrolimus and Mini-Methotrexate for GVHD Prevention After Matched-Unrelated Donor Blood and Marrow Transplantation

Phase 1/Phase 2
Not Enrolling
Leukemia, Lymphoma

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Trial Information

Phase I/II Study of Pentostatin Combined With Tacrolimus and Mini-Methotrexate for GVHD Prevention After Matched-Unrelated Donor Blood and Marrow Transplantation

During the study, patients will have blood, urine, bone marrow, and X-ray exams done. These
exams are done to monitor the results of the transplantation. Blood tests will be done daily
while patients are hospitalized.

Patients in this study will receive chemotherapy and/or radiation to treat their malignancy
and prevent graft rejection. This is given before the infusion of donor cells.

Patients with myeloid leukemias may receive busulfan by vein (IV) for 4 days and
cyclophosphamide by vein for 2 days.

Patients with lymphoid malignancies may receive thiotepa by vein in one dose,
cyclophosphamide by vein for 2 days, and irradiation for 4 days.

Other chemotherapy treatments may be used before donor cell infusion.

IV injections will be given through a previously inserted catheter that extends into the
vena cava (a large chest vein).

Patients will be randomly picked (as in the toss of a coin) to receive one of five different
treatments. This is done to learn the benefit of pentostatin treatment and the appropriate
dose. Four of the treatments will use different dose schedules of pentostatin. The fifth
treatment group will receive no pentostatin at all. All patients receive tacrolimus and

Pentostatin will be given by vein in 4 doses during the first month after transplant.
Tacrolimus (FK506) will be given by vein or mouth for 6 months. Methotrexate will be given
by vein for 3 doses in the first week after transplant.

Patients will receive blood and platelet transfusions after the transplant. The number of
transfusions will depend on how quickly the blood cell counts return to a normal range.

Patients will remain in the hospital for about 4-6 weeks and in the Houston area for 100
days after the transplant.

This is an investigational study. All of the study drugs are commercially available.
Pentostatin will not be used for GVHD prevention outside of this study. A total of 150
patients will take part in this study.

Inclusion Criteria:

1. Patients receiving allogeneic hematopoietic transplants from an unrelated donor or
one antigen mismatched related donors.

2. Patients with AML, ALL, Hodgkin's disease, MDS (including CMML), CML in late chronic
or accelerated phase or in blast crisis, and lymphoma in first or later relapses.

3. Patients must have bilirubin < 1.5 mg/dL, DLCO > 50% predicted, LVEF > 45% and
performance status 0 or 1.

4. Candidates must have a creatinine level < 1.5 mg/dL or a calculated creatinine
clearance > 60 ml/min.

Exclusion Criteria:

1. HIV seropositivity

2. Uncontrolled infection

3. Pregnancy

4. Candidates should not have received chemotherapy other than hydroxyurea or Gleevec
for at least 3 weeks prior to treatment. Maintenance therapy with oral chemotherapy
is acceptable. Treatment day is defined as transplant day +8, which is the date of
first dose of pentostatin.

5. Diagnosis of myelofibrosis.

Type of Study:


Study Design:

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

Outcome Measure:

Number of Patients Without GVHD at 100 Days

Outcome Description:

The primary efficacy endpoint of escalating doses Pentostatin with Tacrolimus + Methotrexate is success, defined to be that the patient is alive, engrafted, and without acute graft-versus-host disease (GVHD) at 100 days.

Outcome Time Frame:

100 days

Safety Issue:


Principal Investigator

Marcos de Lima, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

September 2000

Completion Date:

November 2009

Related Keywords:

  • Leukemia
  • Lymphoma
  • Graft-Versus-Host Disease
  • GVHD Prevention
  • Hodgkin's Disease
  • Leukemia
  • Lymphoma
  • Methotrexate
  • Tacrolimus
  • Pentostatin
  • Leukemia
  • Lymphoma



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