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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 MedicineHouston, Texas  77030
Fred Hutchinson Cancer Research CenterSeattle, Washington  98109
University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Cardinal Bernardin Cancer Center at Loyola University Medical CenterMaywood, Illinois  60153-5500
MBCCOP - HawaiiHonolulu, Hawaii  96813
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
CCOP - WichitaWichita, Kansas  67214-3882
University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811
CCOP - Atlanta RegionalAtlanta, Georgia  30342-1701
CCOP - Kansas CityKansas City, Missouri  64131
Massachusetts General Hospital Cancer CenterBoston, Massachusetts  02114
Veterans Affairs Outpatient Clinic - MartinezMartinez, California  94553
Veterans Affairs Medical Center - LexingtonLexington, Kentucky  40511-1093
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
Veterans Affairs Medical Center - AlbanyAlbany, New York  12208
Veterans Affairs Medical Center - DaytonDayton, Ohio  45428
CCOP - DaytonKettering, Ohio  45429
CCOP - GreenvilleGreenville, South Carolina  29615
University of Colorado Cancer Center at University of Colorado Health Sciences CenterDenver, Colorado  80010
CCOP - Columbia River Oncology ProgramPortland, Oregon  97225
Cancer Research Center of HawaiiHonolulu, Hawaii  96813
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
Veterans Affairs Medical Center - TucsonTucson, Arizona  85723
USC/Norris Comprehensive Cancer Center and HospitalLos Angeles, California  90033-0804
Veterans Affairs Medical Center - DenverDenver, Colorado  80220
Dwight David Eisenhower Army Medical CenterFort Gordon, Georgia  30905-5650
Veterans Affairs Medical Center - WichitaWichita, Kansas  67218
MBCCOP - LSU Health Sciences CenterNew Orleans, Louisiana  70112
Veterans Affairs Medical Center - ShreveportShreveport, Louisiana  71130
Veterans Affairs Medical Center - DetroitDetroit, Michigan  48201-1932
Veterans Affairs Medical Center - JacksonJackson, Mississippi  39216
Veterans Affairs Medical Center - AlbuquerqueAlbuquerque, New Mexico  87108-5138
Veterans Affairs Medical Center - CincinnatiCincinnati, Ohio  45220-2288
Veterans Affairs Medical Center - Oklahoma CityOklahoma City, Oklahoma  73104
Veterans Affairs Medical Center - CharlestonCharleston, South Carolina  29401-5799
Veterans Affairs Medical Center - San Antonio (Murphy)San Antonio, Texas  78284
Veterans Affairs Medical Center - TempleTemple, Texas  76504
Veterans Affairs Medical Center - Salt Lake CitySalt Lake City, Utah  84148
CCOP - Virginia Mason Research CenterSeattle, Washington  98101
Veterans Affairs Medical Center - SeattleSeattle, Washington  98108
CCOP - NorthwestTacoma, Washington  98405-0986
Madigan Army Medical CenterTacoma, Washington  98431-5048
Veterans Affairs Medical Center - New OrleansNew Orleans, Louisiana  70112
Sutter Cancer CenterSacramento, California  95816
University of California Davis Cancer CenterSacramento, California  95817
City of Hope Comprehensive Cancer CenterDuarte, California  91010
Veterans Affairs Medical Center - AmarilloAmarillo, Texas  79106
Arizona Cancer Center at University of Arizona Health Sciences CenterTucson, Arizona  85724
Arkansas Cancer Research Center at University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Veterans Affairs Medical Center - Tampa (Haley)Tampa, Florida  33612
Kansas Masonic Cancer Research Institute at the University of Kansas Medical CenterKansas City, Kansas  66160-7353
Markey Cancer Center at University of Kentucky Chandler Medical CenterLexington, Kentucky  40536-0084
Tulane Cancer Center at Tulane University Hospital and ClinicNew Orleans, Louisiana  70112
Cancer Research Center at Boston Medical CenterBoston, Massachusetts  02118
Herbert Irving Comprehensive Cancer Center at Columbia UniversityNew York, New York  10032
Cancer Institute at Oregon Health and Science UniversityPortland, Oregon  97201-3098
Swedish Cancer Institute at Swedish Medical Center - First Hill CampusSeattle, Washington  98104
Oklahoma University Medical CenterOklahoma City, Oklahoma  73104
Stanford Cancer Center at Stanford University Medical CenterStanford, California  94305
Wilford Hall Medical CenterLackland Air Force Base, Texas  78236-5300
NYU Cancer Institute at New York University Medical CenterNew York, New York  10016
Scripps Cancer Center at Scripps ClinicLa Jolla, California  92037
James P. Wilmot Cancer Center at University of Rochester Medical CenterRochester, New York  14642
Banner Good Samaritan Medical CenterPhoenix, Arizona  85006
Veterans Affairs Medical Center - Little RockLittle Rock, Arkansas  72205
Veterans Affairs Medical Center - HinesHines, Illinois  60141
Josephine Ford Cancer Center at Henry Ford Health SystemDetroit, Michigan  48202
University of Tennessee Cancer Institute at Methodist Central HospitalMemphis, Tennessee  38104
Jonsson Comprehensive Cancer Center at UCLALos Angeles, California  90095-1781
Mountain States Tumor Institute - BoiseBoise, Idaho  83712
Chao Family Comprehensive Cancer Center at University of California Irvine Medical CenterOrange, California  92868
General Robert Huyser Cancer Center at David Grant Medical CenterTravis Air Force Base, California  94535
Huntsman Cancer Institute at University of UtahSalt Lake City, Utah  84112
Veterans Affairs Medical Center - Chicago Westside HospitalChicago, Illinois  60612
John Muir/Mt. Diablo Comprehensive Cancer CenterWalnut Creek, California  94598
Charles B. Eberhart Cancer Center at DeKalb Medical CenterDecatur, Georgia  30033
Feist-Weiller Cancer Center at Louisiana State University Health SciencesShreveport, Louisiana  71130-3932
Providence Cancer Institute at Providence Hospital - Southfield CampusSouthfield, Michigan  48075
UMC Southwest Cancer and Research CenterLubbock, Texas  79415-3364
Saint Louis University Cancer CenterSaint Louis, Missouri  63110
Indiana Blood and Marrow TransplantationIndianapolis, Indiana  46202
New Orleans Cancer Institute at Memorial Medical CenterNew Orleans, Louisiana  70115