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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 2
55 Years
69 Years
Not Enrolling
Both
Leukemia

Thank you

Trial Information

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)


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Survival

Outcome Description:

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

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

Peter McSweeney, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Rocky Mountain Cancer Centers - Denver Midtown

Authority:

United States: Federal Government

Study ID:

CDR0000269049

NCT ID:

NCT00053014

Start Date:

April 2003

Completion Date:

June 2006

Related Keywords:

  • Leukemia
  • 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
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

Name

Location

Baylor College of Medicine Houston, Texas  77030
Fred Hutchinson Cancer Research Center Seattle, Washington  98109
University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan  48109-0752
Cardinal Bernardin Cancer Center at Loyola University Medical Center Maywood, Illinois  60153-5500
MBCCOP - Hawaii Honolulu, Hawaii  96813
Barbara Ann Karmanos Cancer Institute Detroit, Michigan  48201
University of Mississippi Medical Center Jackson, Mississippi  39216-4505
CCOP - Wichita Wichita, Kansas  67214-3882
University of Texas Health Science Center at San Antonio San Antonio, Texas  78284-7811
CCOP - Atlanta Regional Atlanta, Georgia  30342-1701
CCOP - Kansas City Kansas City, Missouri  64131
Massachusetts General Hospital Cancer Center Boston, Massachusetts  02114
Veterans Affairs Outpatient Clinic - Martinez Martinez, California  94553
Veterans Affairs Medical Center - Lexington Lexington, Kentucky  40511-1093
CCOP - Montana Cancer Consortium Billings, Montana  59101
Veterans Affairs Medical Center - Albany Albany, New York  12208
Veterans Affairs Medical Center - Dayton Dayton, Ohio  45428
CCOP - Dayton Kettering, Ohio  45429
CCOP - Greenville Greenville, South Carolina  29615
University of Colorado Cancer Center at University of Colorado Health Sciences Center Denver, Colorado  80010
CCOP - Columbia River Oncology Program Portland, Oregon  97225
Cancer Research Center of Hawaii Honolulu, Hawaii  96813
Cleveland Clinic Taussig Cancer Center Cleveland, Ohio  44195
Veterans Affairs Medical Center - Tucson Tucson, Arizona  85723
USC/Norris Comprehensive Cancer Center and Hospital Los Angeles, California  90033-0804
Veterans Affairs Medical Center - Denver Denver, Colorado  80220
Dwight David Eisenhower Army Medical Center Fort Gordon, Georgia  30905-5650
Veterans Affairs Medical Center - Wichita Wichita, Kansas  67218
MBCCOP - LSU Health Sciences Center New Orleans, Louisiana  70112
Veterans Affairs Medical Center - Shreveport Shreveport, Louisiana  71130
Veterans Affairs Medical Center - Detroit Detroit, Michigan  48201-1932
Veterans Affairs Medical Center - Jackson Jackson, Mississippi  39216
Veterans Affairs Medical Center - Albuquerque Albuquerque, New Mexico  87108-5138
Veterans Affairs Medical Center - Cincinnati Cincinnati, Ohio  45220-2288
Veterans Affairs Medical Center - Oklahoma City Oklahoma City, Oklahoma  73104
Veterans Affairs Medical Center - Charleston Charleston, South Carolina  29401-5799
Veterans Affairs Medical Center - San Antonio (Murphy) San Antonio, Texas  78284
Veterans Affairs Medical Center - Temple Temple, Texas  76504
Veterans Affairs Medical Center - Salt Lake City Salt Lake City, Utah  84148
CCOP - Virginia Mason Research Center Seattle, Washington  98101
Veterans Affairs Medical Center - Seattle Seattle, Washington  98108
CCOP - Northwest Tacoma, Washington  98405-0986
Madigan Army Medical Center Tacoma, Washington  98431-5048
Veterans Affairs Medical Center - New Orleans New Orleans, Louisiana  70112
Sutter Cancer Center Sacramento, California  95816
University of California Davis Cancer Center Sacramento, California  95817
City of Hope Comprehensive Cancer Center Duarte, California  91010
Veterans Affairs Medical Center - Amarillo Amarillo, Texas  79106
Arizona Cancer Center at University of Arizona Health Sciences Center Tucson, Arizona  85724
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences Little Rock, Arkansas  72205
Veterans Affairs Medical Center - Tampa (Haley) Tampa, Florida  33612
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center Kansas City, Kansas  66160-7353
Markey Cancer Center at University of Kentucky Chandler Medical Center Lexington, Kentucky  40536-0084
Tulane Cancer Center at Tulane University Hospital and Clinic New Orleans, Louisiana  70112
Cancer Research Center at Boston Medical Center Boston, Massachusetts  02118
Herbert Irving Comprehensive Cancer Center at Columbia University New York, New York  10032
Cancer Institute at Oregon Health and Science University Portland, Oregon  97201-3098
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus Seattle, Washington  98104
Oklahoma University Medical Center Oklahoma City, Oklahoma  73104
Stanford Cancer Center at Stanford University Medical Center Stanford, California  94305
Wilford Hall Medical Center Lackland Air Force Base, Texas  78236-5300
NYU Cancer Institute at New York University Medical Center New York, New York  10016
Scripps Cancer Center at Scripps Clinic La Jolla, California  92037
James P. Wilmot Cancer Center at University of Rochester Medical Center Rochester, New York  14642
Banner Good Samaritan Medical Center Phoenix, Arizona  85006
Veterans Affairs Medical Center - Little Rock Little Rock, Arkansas  72205
Veterans Affairs Medical Center - Hines Hines, Illinois  60141
Josephine Ford Cancer Center at Henry Ford Health System Detroit, Michigan  48202
University of Tennessee Cancer Institute at Methodist Central Hospital Memphis, Tennessee  38104
Jonsson Comprehensive Cancer Center at UCLA Los Angeles, California  90095-1781
Mountain States Tumor Institute - Boise Boise, Idaho  83712
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center Orange, California  92868
General Robert Huyser Cancer Center at David Grant Medical Center Travis Air Force Base, California  94535
Huntsman Cancer Institute at University of Utah Salt Lake City, Utah  84112
Veterans Affairs Medical Center - Chicago Westside Hospital Chicago, Illinois  60612
John Muir/Mt. Diablo Comprehensive Cancer Center Walnut Creek, California  94598
Charles B. Eberhart Cancer Center at DeKalb Medical Center Decatur, Georgia  30033
Feist-Weiller Cancer Center at Louisiana State University Health Sciences Shreveport, Louisiana  71130-3932
Providence Cancer Institute at Providence Hospital - Southfield Campus Southfield, Michigan  48075
UMC Southwest Cancer and Research Center Lubbock, Texas  79415-3364
Saint Louis University Cancer Center Saint Louis, Missouri  63110
Indiana Blood and Marrow Transplantation Indianapolis, Indiana  46202
New Orleans Cancer Institute at Memorial Medical Center New Orleans, Louisiana  70115