Know Cancer

forgot password

Phase I/II Trial of Decitabine and Allogeneic Peripheral Blood Stem Cells Transplantation for Treatment of Relapse Post Allogeneic Bone Marrow Transplantation

Phase 1/Phase 2
60 Years
Not Enrolling
Leukemia, Myelodysplastic Syndromes

Thank you

Trial Information

Phase I/II Trial of Decitabine and Allogeneic Peripheral Blood Stem Cells Transplantation for Treatment of Relapse Post Allogeneic Bone Marrow Transplantation

OBJECTIVES: I. Determine the maximum tolerated dose of decitabine in patients with relapse
post allogenic bone marrow transplant. II. Determine the toxicity of decitabine combined
with filgrastim (G-CSF) primed allogeneic peripheral blood stem cells in patients who
relapsed within 1 year after allogeneic bone marrow transplantation. III. Determine the
effectiveness in reinducing remission in these patients.

OUTLINE: Patients receive decitabine IV for 6 hours every 12 hr for 5 days. Peripheral blood
stem cells (PBSC) are administered 5 days after last dose of decitabine. Donors receive
filgrastim subcutaneously (SQ) daily every 12 hours starting 2-4 days prior to first PBSC
collection. If insufficient number of cells are collected, bone marrow can be harvested for
supplementation. Donor cells should be collected prior to decitabine infusion. Patients
receive filgrastim SQ administered daily starting 1 day after PBSC infusion until blood
counts recover. For GVHD prophylaxis, patients receive cyclosporine IV daily on day -2, then
orally once dose is tolerable. Dose of decitabine is escalated in cohorts of 3-6 patients.
If dose limiting toxicity occurs in 2 of 6 patients at a given dose level, then that dose is
declared the maximum tolerated dose. Patients are followed weekly. If none of the first 5
patients survive in remission for more than 100 days, the study will be terminated.

PROJECTED ACCRUAL: At least 15 patients will be accrued for this study over 2 years.

Inclusion Criteria

DISEASE CHARACTERISTICS: Acute leukemia, myelodysplastic syndromes or chronic myelogenous
leukemia (CML) in accelerated phase or blast crisis and relapsed within 1 year after
allogeneic bone marrow transplantation Must not be candidates for second course of high
dose chemoradiotherapy

PATIENT CHARACTERISTICS: Age: 60 and under Performance status: Zubrod 0-2 Life expectancy:
Not specified Hematopoietic: Not specified Hepatic: Bilirubin less than 3 mg/dL Renal:
Creatinine less than 2 mg/dL Cardiovascular: Greater than 40% ejection fraction per MUGA
scan or ECHO Other: Not pregnant No serious intercurrent illness No active CNS disease
Must be ineligible for protocols of higher priority No active acute graft vs host disease
(GVHD) greater than grade 2 or extensive chronic GVHD No active uncontrolled infection
Original marrow donor must undergo filgrastim primed peripheral blood stem cell collection

PRIOR CONCURRENT THERAPY: See Disease Characteristics

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:

Maximum Tolerated Dose (MTD) Decitabine

Outcome Time Frame:

Weekly for 1 year

Safety Issue:


Principal Investigator

Sergio Giralt, MD

Investigator Role:

Study Chair

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Federal Government

Study ID:




Start Date:

August 1995

Completion Date:

March 2002

Related Keywords:

  • Leukemia
  • Myelodysplastic Syndromes
  • Decitabine
  • Dacogen
  • Filgrastim
  • G-CSF
  • Neupogen
  • Cyclosporine
  • Sandimmune
  • CYA
  • Cyclosporin A
  • Peripheral blood stem cells
  • PBSC
  • Allogeneic bone marrow transplantation
  • recurrent childhood acute lymphoblastic leukemia
  • recurrent childhood acute myeloid leukemia
  • recurrent adult acute myeloid leukemia
  • recurrent adult acute lymphoblastic leukemia
  • accelerated phase chronic myelogenous leukemia
  • blastic phase chronic myelogenous leukemia
  • previously treated myelodysplastic syndromes
  • childhood myelodysplastic syndromes
  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Myelodysplastic Syndromes
  • Preleukemia



University of Texas - MD Anderson Cancer Center Houston, Texas  77030-4009