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A Randomized, Multi-Center, Phase III Study of Allogeneic Stem Cell Transplantation Comparing Regimen Intensity in Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia


Phase 3
18 Years
65 Years
Open (Enrolling)
Both
Leukemia, Myelocytic, Acute

Thank you

Trial Information

A Randomized, Multi-Center, Phase III Study of Allogeneic Stem Cell Transplantation Comparing Regimen Intensity in Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia


Patients randomized to RIC will receive one of two regimen types: the combination of
fludarabine (120-180 mg/m^2) and busulfan (less than or equal to 8 mg/kg or IV equivalent)
(Flu/Bu) or fludarabine (120-180 mg/m^2) and melphalan (less than 150 mg/m^2) (Flu/Mel).
Patient randomized to MAC will receive one of three regimens: busulfan (16 mg/kg oral or
12.8 mg/kg IV equivalent) and cyclophosphamide (120 mg/kg) (Bu/Cy); or, busulfan (16 mg/kg
PO or 12.8 mg/kg IV) and fludarabine (120-180 mg/m^2) (Bu/Flu); or, cyclophosphamide (120
mg/kg) and total body irradiation (greater than 1200-1420cGy) (CyTBI). A total of 356
patients (178 to each arm) will be accrued on this study over a period of four years.
Patients will be followed for up to 18 months from transplantation.


Inclusion Criteria:



- Age equal or less than 65 years old and equal to or greater than 18 years old.

- Patients with the diagnosis of MDS or AML with fewer than 5% myeloblasts in the bone
marrow and no leukemic myeloblasts in the peripheral blood on morphologic analysis
performed within 30 days of start of the conditioning regimen enrollment.

- For patients receiving treatment of their MDS or AML prior to transplantation:
a)Interval between the start of the most recent cycle of conventional cytotoxic
chemotherapy and enrollment must be at least 30 days; b)Interval between completing
treatment with a hypomethylating agent or other non-cytotoxic chemotherapy and
enrollment must be at least 10 days.

- Patients must have a related or unrelated bone marrow or peripheral blood donor who
is HLA-matched at 7 or 8 of 8 HLA-A, -B, -C and -DRB1 at high resolution using
DNA-based typing.

- HCT-Specific Comorbidity Index Score (HCT-CI) less than or equal to 4.

- Organ function: a) Cardiac function: Ejection fraction greater than or equal to 40%;
b) Hepatic function: total bilirubin less than or equal to 2 times the upper limit of
normal and ALT and AST less than or equal to 3 times the upper limit of normal.;
c)Pulmonary function: DLCO greater than or equal to 40% and FEV1 greater than or
equal to 50% (corrected for hemoglobin.

- Creatinine clearance greater than or equal to 50mL/min based on the Cockcroft-Gault
formula.

- Signed informed consent.

Exclusion Criteria:

- Prior allograft or prior autograft.

- Symptomatic coronary artery disease.

- Leukemia involvement in the CNS within 4 weeks of enrollment for patients with a
history of prior CNS leukemia involvement (i.e., leukemic blasts previously detected
in the cerebral spinal fluid).

- Karnofsky Performance Score less than 70.

- Patients receiving supplemental oxygen.

- Planned use of DLI therapy.

- Patients with uncontrolled bacterial, viral or fungal infections (undergoing
appropriate treatment and with progression of clinical symptoms).

- Patients seropositive for the human immunodeficiency virus (HIV).

- Patients with prior malignancies, except resected basal cell carcinoma or treated
cervical carcinoma in situ. Cancer treated with curative intent greater than 5 years
previously. Cancer treated with curative intent less than 5 years previously will
not be allowed unless approved by the Protocol Officer or one of the Protocol Chairs.

- Females who are pregnant or breastfeeding.

- Fertile men and women unwilling to use contraceptive techniques during and for 12
months following treatment.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Survival

Outcome Description:

The primary objective of the trial is to compare 18 month overall survival rates of the two groups of patients starting from the time of randomization to the RIC or MAC arms.

Outcome Time Frame:

18 months

Safety Issue:

No

Principal Investigator

Bart Scott, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Fred Hutchinson Cancer Research Center

Authority:

United States: Federal Government

Study ID:

709

NCT ID:

NCT01339910

Start Date:

May 2011

Completion Date:

November 2017

Related Keywords:

  • Leukemia, Myelocytic, Acute
  • Acute Myelogenous Leukemia
  • Myelodysplastic Syndrome
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Myelodysplastic Syndromes
  • Preleukemia

Name

Location

Cleveland Clinic FoundationCleveland, Ohio  44195
Fred Hutchinson Cancer Research CenterSeattle, Washington  98109
Mayo Clinic ScottsdaleScottsdale, Arizona  85259
University of Pennsylvania Cancer CenterPhiladelphia, Pennsylvania  19104
Medical College of WisconsinMilwaukee, Wisconsin  53226
University of Nebraska Medical CenterOmaha, Nebraska  68198-3330
Mount Sinai Medical CenterNew York, New York  10029
Baylor University Medical CenterDallas, Texas  75246
University of MinnesotaMinneapolis, Minnesota  55455
Oregon Health & Science UniversityPortland, Oregon  97201
Duke University Medical CenterDurham, North Carolina  27710
H. Lee Moffitt Cancer CenterTampa, Florida  33612
Emory UniversityAtlanta, Georgia  30322
University of Wisconsin Hospital & ClinicsMadison, Wisconsin  53792
University of KentuckyLexington, Kentucky  40536-0098
Texas Transplant InstituteSan Antonio, Texas  78229
University of California, San Diego Medical CenterSan Diego, California  
Tufts Medical CenterBoston, Massachusetts  02111
University Hospitals of Cleveland/Case WesternCleveland, Ohio  44106
University of Oklahoma Medical CenterOklahoma City, Oklahoma  73104
Baylor College of Medicine/The Methodist HospitalHouston, Texas  77030-2399
Utah BMT/University of Utah Medical SchoolSalt Lake City, Utah  84132
Blood and Marrow Transplant Program at Northside HospitalAtlanta, Georgia  30342
University of North Carolina Hospital at Chapel HillChapel Hill, North Carolina  27599
West Virginia University HospitalMorgantown, West Virginia  26506-9162
University of Florida College of MedicineGainesville, Florida  32610
University Of KansasKansas City, Kansas  66160
Jewish Hospital BMT ProgramCincinnati, Ohio  45236
DFCI, Brigham & Women's HospitalBoston, Massachusetts  02114