S0125, Chemotherapy, Total-Body Irradiation, and Peripheral Stem Cell Transplantation in Treating Older Patients With Acute Myeloid Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00053014
Recruitment Status : Terminated (Poor accrual)
First Posted : January 28, 2003
Results First Posted : March 22, 2013
Last Update Posted : March 25, 2015
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Leukemia Biological: therapeutic allogeneic lymphocytes Drug: cyclosporine Drug: fludarabine Drug: mycophenolate mofetil Procedure: peripheral blood stem cell transplantation Radiation: radiation therapy Phase 2

Detailed Description:

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : April 2003
Actual Primary Completion Date : June 2005
Actual Study Completion Date : June 2006

Arm Intervention/treatment
Experimental: treatment
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
Biological: therapeutic allogeneic lymphocytes Drug: cyclosporine Drug: fludarabine Drug: mycophenolate mofetil
Other Name: MMF
Procedure: peripheral blood stem cell transplantation Radiation: radiation therapy

Primary Outcome Measures :
  1. Overall Survival [ Time Frame: 1 year ]
    measured from date of registration to study until death from any cause with patients still alive censored at date of last contact

Secondary Outcome Measures :
  1. Serious Adverse Events [ Time Frame: 9 months ]
    Twice a week for the first two months, one time a week during month 3, one time every two weeks for months 4-9.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   55 Years to 69 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00053014

  Show 83 Study Locations
Sponsors and Collaborators
Southwest Oncology Group
National Cancer Institute (NCI)
Study Chair: Peter McSweeney, MD Rocky Mountain Cancer Centers - Denver Midtown

Responsible Party: Southwest Oncology Group Identifier: NCT00053014     History of Changes
Other Study ID Numbers: S0125
S0125 ( Other Identifier: SWOG )
U10CA032102 ( U.S. NIH Grant/Contract )
First Posted: January 28, 2003    Key Record Dates
Results First Posted: March 22, 2013
Last Update Posted: March 25, 2015
Last Verified: March 2015

Keywords provided by Southwest Oncology Group:
adult acute myeloid leukemia in remission
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

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Fludarabine phosphate
Mycophenolic Acid
Antineoplastic Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Enzyme Inhibitors
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors
Antibiotics, Antineoplastic
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents