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A Phase II Study Of Allogeneic Transplant For Older Patients With AML In First Morphologic Complete Remission Using A Non-Myeloablative Preparative Regimen

Phase 2
60 Years
74 Years
Open (Enrolling)

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Trial Information

A Phase II Study Of Allogeneic Transplant For Older Patients With AML In First Morphologic Complete Remission Using A Non-Myeloablative Preparative Regimen



- Determine whether allogeneic stem cell transplantation from a matched sibling or
unrelated donor using a nonmyeloablative preparative regimen comprising fludarabine and
busulfan results in a 2-year disease-free survival that is better than historical
results using standard chemotherapy in older patients with acute myeloid leukemia in
first morphologic complete remission.


- Determine the 2-year actuarial risks of transplant-related mortality, acute and chronic
graft-versus-host disease, and relapse in patients treated with this regimen.

- Determine the recovery of T- and B-cell number and function and the time course of T,
B, and myeloid progenitor chimerism in patients treated with this regimen.

- Determine the pharmacokinetics of this regimen in these patients.

OUTLINE: This is a multicenter study.

- Preparative regimen: Patients receive fludarabine IV over 30 minutes on days -7 to -3
and busulfan IV over 2 hours 4 times per day (every 6 hours) on days -4 and -3.

- Graft-versus-host disease (GVHD) prophylaxis: Patients receive oral or IV tacrolimus
twice daily starting on days -2, with tapering between days 90-120, and stopping by
days 150-180. Patients also receive methotrexate IV on days 1, 3, 6,and 11 and rabbit
antithymocyte globulin (Thymoglobulin) IV over 4-6 hours on days -4 through -2.

- Allogeneic peripheral blood stem cell transplantation (PBSC): Patients undergo
allogeneic PBSC transplantation on day 0. Patients then receive filgrastim (G-CSF)
subcutaneously daily beginning on day 12 and continuing until blood counts recover.
Patients with progressive disease will be removed from the study and may receive
additional treatment at the discretion of the investigator.

Patients are followed monthly for 1 year, every 3 months for 1 year, and then every 6 months
for 3 years.

PROJECTED ACCRUAL: A total of 61 patients will be accrued for this study.

Inclusion Criteria


- Diagnosis of acute myeloid leukemia (AML) in first morphologic complete remission

- No FAB M3 disease

- Preceding myelodysplastic syndromes and treatment-related AML allowed

- Morphologic complete remission achieved within the past 6 months and after no more
than 2 courses of induction chemotherapy with standard cytotoxic chemotherapy (e.g.,
cytarabine and an anthracycline) or after no more than 4 courses of a hypomethylating
agent-containing regimen including either 5-azacytidine or decitabine

- Complete morphologic remission is defined by all of the following criteria:

- Normal bone marrow morphology with less than 5% blasts

- Absolute neutrophil count greater than 1,000/mm^3*

- Platelet count greater than 100,000/mm^3*

- No extramedullary leukemia

- No blasts in peripheral blood NOTE: *Must be sustained for at least 30 days

- No more than 2 courses of prior consolidation therapy

- Any consolidation regimen that does not require transplantation allowed

- No acute leukemia after blast transformation of prior chronic myelogenous leukemia or
other myeloproliferative disease

- Prior CNS involvement allowed provided the disease is in remission at time of

- The following donors will be allowed:

- Available HLA-identical (6/6) sibling donor by serological typing (A, B, DR)

- Locus matched unrelated donor (10/10) by high resolution molecular typing
(HLA-A, -B, -C, -DRB1, and -DQB1).

- No syngeneic donors



- 60 to 74

Performance status

- 0-2

Life expectancy

- Not specified


- See Disease Characteristics


- Bilirubin less than 2 mg/dL*

- Bilirubin 2-3 mg/dL with normal direct bilirubin allowed

- AST less than 3 times upper limit of normal* NOTE: *Unless attributable to disease


- Creatinine clearance at least 40 mL/min (unless attributable to disease)


- LVEF at least 30% by MUGA or ECHO


- DLCO greater than 40%

- No symptomatic pulmonary disease


- Not pregnant

- Fertile patients must use effective contraception

- HIV negative

- No uncontrolled diabetes mellitus

- No active serious infection requiring antibiotics

- No known hypersensitivity to E. coli-derived products


Biologic therapy

- See Disease Characteristics


- See Disease Characteristics

- At least 4 weeks since prior chemotherapy

Endocrine therapy

- Not specified


- At least 4 weeks since prior radiotherapy


- At least 4 weeks since prior surgery

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival at 2 years

Safety Issue:


Principal Investigator

Steven M. Devine, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Ohio State University Comprehensive Cancer Center


United States: Federal Government

Study ID:




Start Date:

January 2004

Completion Date:

Related Keywords:

  • Leukemia
  • adult acute myeloid leukemia in remission
  • secondary acute myeloid leukemia
  • adult acute monocytic leukemia (M5b)
  • adult acute erythroid leukemia (M6)
  • adult acute megakaryoblastic leukemia (M7)
  • adult acute minimally differentiated myeloid leukemia (M0)
  • adult acute myeloblastic leukemia with maturation (M2)
  • adult acute myeloblastic leukemia without maturation (M1)
  • adult acute myelomonocytic leukemia (M4)
  • adult acute monoblastic leukemia (M5a)
  • adult acute myeloid leukemia with t(8;21)(q22;q22)
  • adult acute myeloid leukemia with t(16;16)(p13;q22)
  • adult acute myeloid leukemia with inv(16)(p13;q22)
  • adult acute myeloid leukemia with 11q23 (MLL) abnormalities
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid



Roswell Park Cancer Institute Buffalo, New York  14263
CCOP - Christiana Care Health Services Wilmington, Delaware  19899
CCOP - North Shore University Hospital Manhasset, New York  11030
Beth Israel Deaconess Medical Center Boston, Massachusetts  02215
Long Island Jewish Medical Center New Hyde Park, New York  11040
Mount Sinai Medical Center New York, New York  10029
Wake Forest University Comprehensive Cancer Center Winston-Salem, North Carolina  27157-1096
Greenebaum Cancer Center at University of Maryland Medical Center Baltimore, Maryland  21201
New York Weill Cornell Cancer Center at Cornell University New York, New York  10021
UCSF Helen Diller Family Comprehensive Cancer Center San Francisco, California  94115
Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute Boston, Massachusetts  02115
Masonic Cancer Center at University of Minnesota Minneapolis, Minnesota  55455
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis St. Louis, Missouri  63110
Don Monti Comprehensive Cancer Center at North Shore University Hospital Manhasset, New York  11030
Cancer Institute of New Jersey at Cooper - Voorhees Voorhees, New Jersey  08043
Massachusetts General Hospital Boston, Massachusetts  02114-2617
Tunnell Cancer Center at Beebe Medical Center Lewes, Delaware  19958
Monter Cancer Center of the North Shore-LIJ Health System Lake Success, New York  11042
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center Columbus, Ohio  43210-1240
Union Hospital of Cecil County Elkton MD, Maryland  21921
Dana-Farber/Brigham and Women's Cancer Center Boston, Massachusetts  02115