S0125, Chemotherapy, Total-Body Irradiation, and Peripheral Stem Cell Transplantation in Treating Older Patients With Acute Myeloid Leukemia
S0125, A Phase II Study Of Chimerism-Mediated Immunotherapy (CMI) Using Nonmyeloablative Allogeneic Peripheral Blood Stem Cell Transplantation In Older Patients With Acute Myeloid Leukemia (AML) In First Complete Remission (A BMT Study)
  • Phase

    Phase 2
  • Study Type

  • Study Participants

RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy and radiation therapy. Sometimes the transplanted cells can make an immune response against the body's normal tissues. Cyclosporine and mycophenolate mofetil may prevent this from happening.

PURPOSE: Phase II trial to study the effectiveness of chemotherapy and total-body irradiation followed by donor peripheral stem cell transplantation, cyclosporine, and mycophenolate mofetil in treating older patients who have acute myeloid leukemia.
Primary objective:

Determine whether allogeneic peripheral blood stem cell transplantation with pre-conditioning low dose total body irradiation and fludarabine followed by cyclosporine and mycophenolate mofetil, when given to elderly patients with acute myeloid leukemia in first complete remission, is sufficiently efficacious (in terms of survival 1 year after transplantation) to warrant a phase III investigation.

Secondary objective:

Determine the frequency and severity of toxic effects of this regimen in these patients.

Other objectives as funding permits:

Determine whether chimerism patterns in bone marrow and blood after transplantation are associated with relapse and/or graft-versus-host disease (GVHD) in these patients.
Determine whether cytogenic, immunophenotypic, and molecular biologic features detected in pre- and post-transplantation specimens are related to transplant outcomes and risk of relapse in these patients.

OUTLINE: This is an open-label study.

Conditioning regimen: Patients receive fludarabine IV over 1 hour on days -4 to -2. Patients also undergo total body irradiation on day 0.
Peripheral blood stem cell infusion (PBSC): Patients receive unmodified filgrastim transplantation (G-CSF)-mobilized donor PBSC on day 0.
Post-transplantation immunosuppression: Patients receive oral cyclosporine on days -3 to 35 followed by a taper until day 180. Patients also receive oral mycophenolate mofetil on day 0 to 27 without tapering.
Donor lymphocyte infusions (DLI): Patients with relapsed disease receive DLI IV over 30 minutes for up to 2 infusions.

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

PROJECTED ACCRUAL: A total of 25-51 patients will be accrued for this study.
Study Started
Apr 30
Primary Completion
Jun 30
Study Completion
Jun 30
Results Posted
Mar 22
Last Update
Mar 25

Biological therapeutic allogeneic lymphocytes

Drug cyclosporine

Drug fludarabine

Drug mycophenolate mofetil

  • Other names: MMF

Procedure peripheral blood stem cell transplantation

Radiation radiation therapy

treatment Experimental

patient conditioning - fludarabine 30 mg/m2 IV over 1 hour Days -4, -3, -2; TBI 6-7 cGy/min Day 0 post-transplant immunosuppression - cyclosporine 6.25 mg/kg bid PO D -3 to +180 (begin taper on D+35); mycophenolate mofetil 15mg/kg bid PO D0 to +27



Morphologically confirmed acute myeloid leukemia (AML) (within 180 days of diagnosis) OR
Secondary AML (secondary to myelodysplastic syndromes (MDS) or to prior leukemogenic therapy)
Must have A1 marrow, B1 blood, and C1 extramedullary disease status
Must have received prior remission induction chemotherapy
Must have a genotypically HLA-identical sibling donor available that is not a monozygotic identical twin
No M3 AML or blastic transformation of chronic myelogenous leukemia
If history of CNS leukemia, no leukemia cells in CNS by lumbar puncture within past 7 days
Must be concurrently enrolled on protocols SWOG-9007 and SWOG-S9910



55 to 69

Performance status

Zubrod 0-2

Life expectancy

Not specified


See Disease Characteristics


Not specified


Not specified


Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
HIV negative

No other malignancy within the past 2 years except for the following:

Adequately treated basal cell or squamous cell skin cancer
Carcinoma in situ of the cervix
Adequately treated stage I or II cancer in complete remission


Biologic therapy

No prior allogeneic hematopoietic stem cell transplantation


See Disease Characteristics
Prior consolidation therapy allowed

Endocrine therapy

Not specified


Not specified


Prior organ transplantation allowed provided not concurrently receiving immunosuppressive therapy



All Events

Event Type Organ System Event Term Treatment

Overall Survival

measured from date of registration to study until death from any cause with patients still alive censored at date of last contact



Serious Adverse Events

Twice a week for the first two months, one time a week during month 3, one time every two weeks for months 4-9.


Age, Continuous

years (Median)
Full Range: 56.0 to 65.0

Region of Enrollment

Sex: Female, Male

Overall Study