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A Phase II Study of Allografting to Establish Mixed or Full Donor Chimerism as Consolidative Immunotherapy for Older Patients With AML in Complete Remission Using Low Dose TBI, PBSC Infusion and Post-Transplant Immunosuppression With Cyclosporine and Mycophenolate Mofetil


Phase 2
55 Years
74 Years
Not Enrolling
Both
Leukemia

Thank you

Trial Information

A Phase II Study of Allografting to Establish Mixed or Full Donor Chimerism as Consolidative Immunotherapy for Older Patients With AML in Complete Remission Using Low Dose TBI, PBSC Infusion and Post-Transplant Immunosuppression With Cyclosporine and Mycophenolate Mofetil


OBJECTIVES: I. Determine whether mixed or full donor chimerism can be safely established in
older patients with acute myeloid leukemia (AML) treated with nonmyeloablative conditioning
comprised of low dose total body irradiation, followed by allogeneic peripheral blood stem
cell transplantation, followed by unrelated donor lymphocyte infusion (DLI). II. Determine
whether mixed chimerism can be safely converted to full donor chimerism in patients treated
with DLI. III. Determine the potential efficacy of this regimen in AML patients who are in
first remission.

OUTLINE: Conditioning: Patients undergo low dose total body irradiation followed by infusion
of allogeneic peripheral blood stem cells (PBSC) on day 0. Donor lymphocyte infusions:
Nonmobilized donor lymphocytes are harvested from the same HLA identical related donor on
day 95 after PBSC transplantation. Eligible patients with mixed chimerism and no graft
versus host disease (GVHD) receive the first donor lymphocyte infusion (DLI) on the same day
that donor lymphocytes are collected. Patients who continue to have mixed chimerism and no
GVHD receive the second DLI at a higher dose level on day 65 after the first DLI. Patients
are followed weekly until day 90, and then monthly thereafter.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 2 years.

Inclusion Criteria


DISEASE CHARACTERISTICS: Acute myeloid leukemia (AML) (de novo or secondary, FAB M1, M2
and M4-7) Must be within 6 months of diagnosis Achieved a chemotherapy induced first
complete remission (CR) Received 1 or more courses of consolidation chemotherapy OR AML in
second or greater CR Patients with a documented first or subsequent CR may proceed to
transplantation if: No morphologic diagnosis of AML or myelodysplastic syndrome Absolute
neutrophil count greater than 1,000/mm3 and platelet count greater than 50,000/mm3 after
any consolidation chemotherapy Availability of an HLA identical related peripheral blood
stem cell donor No syngeneic donor No active CNS leukemia

PATIENT CHARACTERISTICS: Age: Over 55 to under 75 Performance status: Karnofsky 70-100%
Life expectancy: Not specified Hematopoietic: See Disease Characteristics Hepatic:
Bilirubin no greater than 2 times upper limit of normal (ULN) ALT and AST less than 4
times ULN Renal: Creatinine clearance at least 50 mL/min Cardiovascular: Cardiac ejection
fraction at least 40% No poorly controlled hypertension Pulmonary: No severe defects in
pulmonary function testing No requirement for supplementary continuous oxygen

PRIOR CONCURRENT THERAPY: See Disease Characteristics

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Peter McSweeney, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Colorado, Denver

Authority:

United States: Federal Government

Study ID:

00-0119

NCT ID:

NCT00005801

Start Date:

November 1999

Completion Date:

September 2001

Related Keywords:

  • Leukemia
  • adult acute myeloid leukemia in remission
  • adult acute erythroid leukemia (M6)
  • adult acute myeloblastic leukemia without maturation (M1)
  • adult acute myeloblastic leukemia with maturation (M2)
  • adult acute myelomonocytic leukemia (M4)
  • adult acute monoblastic leukemia (M5a)
  • adult acute megakaryoblastic leukemia (M7)
  • adult acute monocytic leukemia (M5b)
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

Name

Location

Fred Hutchinson Cancer Research CenterSeattle, Washington  98109
University of Colorado Cancer CenterDenver, Colorado  80262