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

This study has been terminated.
(Poor accrual)
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00053014
First received: January 27, 2003
Last updated: February 15, 2013
Last verified: February 2013
History of Changes
  Purpose

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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Southwest Oncology Group:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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:
  • Serious Adverse Events [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
    Twice a week for the first two months, one time a week during month 3, one time every two weeks for months 4-9.


Enrollment: 5
Study Start Date: April 2003
Study Completion Date: June 2006
Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   55 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age

  • 55 to 69

Performance status

  • Zubrod 0-2

Life expectancy

  • Not specified

Hematopoietic

  • See Disease Characteristics

Hepatic

  • Not specified

Renal

  • Not specified

Other

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No prior allogeneic hematopoietic stem cell transplantation

Chemotherapy

  • See Disease Characteristics
  • Prior consolidation therapy allowed

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Prior organ transplantation allowed provided not concurrently receiving immunosuppressive therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00053014

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

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00053014     History of Changes
Other Study ID Numbers: CDR0000269049, S0125, U10CA032102
Study First Received: January 27, 2003
Results First Received: January 2, 2013
Last Updated: February 15, 2013
Health Authority: United States: Federal Government

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
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms
Cyclosporins
Cyclosporine
Mycophenolic Acid
Mycophenolate mofetil
Fludarabine monophosphate
Fludarabine
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
 Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Dermatologic Agents
Antirheumatic Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites

ClinicalTrials.gov processed this record on May 22, 2013