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Use of G-CSF Stimulated HLA-Identical Allogeneic Peripheral Blood Stem Cells for Patients With High Risk Acute Myelogenous Leukemia or CML in Blast Crisis


Phase 2
55 Years
70 Years
Not Enrolling
Both
Graft Versus Host Disease, Leukemia, Myelodysplastic Syndromes

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Trial Information

Use of G-CSF Stimulated HLA-Identical Allogeneic Peripheral Blood Stem Cells for Patients With High Risk Acute Myelogenous Leukemia or CML in Blast Crisis


OBJECTIVES: I. Determine the toxic effects and feasibility of using filgrastim in promoting
hematopoietic recovery and leukemia control after intensive but nonmyeloablative salvage
chemotherapy. II. Determine the engraftment kinetics and degree of chimerism achievable.

OUTLINE: The trial will have 2 patient groups. Patients not in remission are assigned to
group 1, while patients in remission are assigned to group 2. Then, groups are divided into
2 treatment arms. Patients failing fludarabine therapy receive cytarabine (Ara-C) IV over 2
hours on days -7, -6, -5, -4 and -3. Beginning 4 hours before the first dose of Ara-C,
patients receive cladribine (2-chlorodeoxyadenosine; 2-CdA) by continuous infusion for 5
days. Patients without prior fludarabine therapy receive fludarabine IV over 30 minutes
daily on days -6, -5, -4 and -3. Ara-C IV begins 4 hours after the beginning of the
fludarabine infusion and continues for 4 hours. Idarubicin IV is given on days -6, -5 and
-4. Donors receive filgrastim SC every 12 hours for 2 days prior to stem cell collection.
Cells are infused on day 0. For GVHD prophylaxis, all patients receive cyclosporine via
continuous IV infusion. Oral cyclosporine is administered once patients tolerate oral
feeding and continued for 6 months postinfusion. Then, the dose of cyclosporine is tapered
10% weekly until discontinued. Methylprednisolone begins 5 days after infusion and is
gradually tapered.

PROJECTED ACCRUAL: A maximum of 15 patients per arm are likely to be entered in 24 to 36
months.

Inclusion Criteria


DISEASE CHARACTERISTICS: Acute leukemia with poor risk cytogenetic features (-5,-7, +8) in
first complete remission Poor risk myelodysplasia Refractory anemia with excess blasts
(RAEB) RAEB in transformation (RAEB-T) Chronic myelomonocytic leukemia (CMML) Chronic
myelogenous leukemia (CML) in late chronic phase Acute leukemia with greater than first
complete remission or transformed CML or CMML

PATIENT CHARACTERISTICS: Age: 55 to 65 65 to 70 (at the discretion of study chairperson on
basis of performance status) 55 and under (if declined for conventional high dose
chemotherapy due to concurrent medical conditions (i.e. ejection fraction less than 50,
FEV1, FVC, or DLCO less than 50%, abnormal LFTs) Performance status: Zubrod less than 2
Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin less than 3
mg/dL Renal: Serum creatinine less than 2 mg/dL Cardiovascular: Ejection fraction greater
than 40% per MUGA scan Pulmonary: Not specified Other: No active uncontrolled infection
HLA compatible donor capable of donating stem cells via apheresis

PRIOR CONCURRENT THERAPY: Not specified

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Toxic Effects of Peripheral Stem Cell Transplantation + Filgrastim

Outcome Description:

Effectiveness as determined by toxic effects and feasibility of using filgrastim in promoting hematopoietic recovery and leukemia control after intensive but nonmyeloablative salvage chemotherapy

Outcome Time Frame:

24 - 36 months

Safety Issue:

No

Principal Investigator

Sergio Giralt, MD

Investigator Role:

Study Chair

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Federal Government

Study ID:

DM94-078

NCT ID:

NCT00002833

Start Date:

October 1994

Completion Date:

April 2002

Related Keywords:

  • Graft Versus Host Disease
  • Leukemia
  • Myelodysplastic Syndromes
  • recurrent adult acute myeloid leukemia
  • relapsing chronic myelogenous leukemia
  • chronic phase chronic myelogenous leukemia
  • accelerated phase chronic myelogenous leukemia
  • blastic phase chronic myelogenous leukemia
  • adult acute myeloid leukemia in remission
  • Philadelphia chromosome positive chronic myelogenous leukemia
  • refractory anemia with excess blasts
  • refractory anemia with excess blasts in transformation
  • chronic myelomonocytic leukemia
  • graft versus host disease
  • Graft vs Host Disease
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Myelodysplastic Syndromes
  • Preleukemia

Name

Location

University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009