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A Multi-Center, Open Label, Randomized, Active Controlled Phase II/III Clinical Trial to Evaluate the Safety and Efficacy of Processed Unrelated Bone Marrow in Patients With Acute or Chronic Leukemia


Phase 2/Phase 3
12 Years
50 Years
Not Enrolling
Both
Graft Versus Host Disease, Leukemia, Myelodysplastic Syndromes

Thank you

Trial Information

A Multi-Center, Open Label, Randomized, Active Controlled Phase II/III Clinical Trial to Evaluate the Safety and Efficacy of Processed Unrelated Bone Marrow in Patients With Acute or Chronic Leukemia


OBJECTIVES:

- Compare the efficacy of processed (cell depleted) vs unprocessed (conventional)
unrelated bone marrow transplantation in reducing grade III/IV acute graft vs host
disease (GVHD) in patients with acute or chronic leukemia or myelodysplastic syndromes.

- Compare the safety of these regimens in these patients.

- Compare the disease-free survival rate at 100 days and at 6 months in patients treated
with these regimens.

- Compare the time to engraftment and percent engraftment in patients treated with these
regimens.

- Compare the reduction rate of grade II or greater acute and chronic GVHD in patients
treated with these regimens.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified
according to degree of HLA matching and disease (chronic vs acute). Acute myelogenous
leukemia patients are further stratified according to prior myelodysplastic syndromes (yes
vs no). Patients are randomized to one of two bone marrow transplantation arms.

All patients receive a conditioning regimen comprising fludarabine IV on day -6,
cyclophosphamide IV on days -5 and -4, anti-thymocyte globulin IV on days -4 and -2, and
total body irradiation on days -3 to 0. Patients also receive methylprednisolone IV every 12
hours for 4 doses on days -2 to 0. Tacrolimus IV is administered continuously on day -1 and
continues either orally or IV for 6 months. Bone marrow is infused on day 0. Filgrastim
(G-CSF) is administered subcutaneously from day 0 until blood counts recover.

- Arm I: Patients receive allogeneic bone marrow that has been processed to produce a
mononuclear cell preparation.

- Arm II: Patients receive unprocessed allogeneic bone marrow. Patients are followed
weekly for 100 days and then at 6 months.

PROJECTED ACCRUAL: A total of 260 patients will be accrued for this study within 17 months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of one of the following:

- Acute myelogenous leukemia (AML) or acute lymphocytic leukemia (ALL) in first
early relapse, second remission, or subsequent remission

- AML in first complete remission with one of the following adverse features:

- Antecedent hematologic disorder such as myelodysplasia

- AML resulting from prior chemotherapy or radiotherapy

- More than 1 course of induction chemotherapy to achieve remission or
adverse cytogenetics such as Philadelphia chromosome 9:22, +8, +11;
abnormal 12p; or deletions of chromosomes 5, 7, or 20 (3:3)

- ALL in first complete remission with poor risk cytogenetics such as

- Philadelphia chromosome 9:22, 8:14, or 4:11 OR

- WBC greater than 100,000/mm3 OR

- Time to achieve complete remission more than 4 weeks

- Chronic myelogenous leukemia in chronic or accelerated phase

- Myelodysplastic syndromes

- Refractory anemia with excess blasts (RAEB) OR

- RAEB in transformation

- Unrelated bone marrow donor available

- If matched at 6 of 6 HLA-A, -B, and -DR loci, patient must be 12 to 50 years

- If matched at 5 of 6 loci, patient must be 12 to 35 years

- No matched sibling donor available

- No uncontrolled CNS leukemia

PATIENT CHARACTERISTICS:

Age:

- See Disease Characteristics

- 12 to 50

Performance status:

- Karnofsky 70-100%

Life expectancy:

- At least 12 weeks

Hematopoietic:

- See Disease Characteristics

Hepatic:

- Bilirubin less than 2.5 times upper limit of normal (ULN)

- SGOT or SGPT less than 2.5 times ULN

Renal:

- Creatinine no greater than 1.5 mg/dL

Cardiovascular:

- LVEF greater than 50% without medication

Pulmonary:

- DLCO and FVC at least 50% predicted

Other:

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No other serious medical illness

- No uncontrolled diabetes mellitus

- No uncontrolled and/or active infection

- HIV negative

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- At least 3 weeks since prior immunotherapy and recovered

- At least 1 year since prior autologous transplantation

- No prior allogeneic transplantation

Chemotherapy:

- See Disease Characteristics

- At least 3 weeks since prior chemotherapy (except hydroxyurea) and recovered

Endocrine therapy:

- At least 3 weeks since prior hormonal therapy and recovered

Radiotherapy:

- See Disease Characteristics

- At least 3 weeks since prior radiotherapy and recovered

- No prior radiotherapy at doses that would preclude study

Surgery:

- Not specified

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

James N. Lowder, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Chimeric Therapies

Authority:

United States: Federal Government

Study ID:

CHIMERIC-HM01

NCT ID:

NCT00004255

Start Date:

March 2000

Completion Date:

May 2003

Related Keywords:

  • Graft Versus Host Disease
  • Leukemia
  • Myelodysplastic Syndromes
  • recurrent childhood acute lymphoblastic leukemia
  • recurrent childhood acute myeloid leukemia
  • recurrent adult acute myeloid leukemia
  • recurrent adult acute lymphoblastic leukemia
  • chronic phase chronic myelogenous leukemia
  • accelerated phase chronic myelogenous leukemia
  • adult acute myeloid leukemia in remission
  • adult acute lymphoblastic leukemia in remission
  • childhood acute myeloid leukemia in remission
  • childhood acute lymphoblastic leukemia in remission
  • refractory anemia with excess blasts
  • refractory anemia with excess blasts in transformation
  • secondary acute myeloid leukemia
  • de novo myelodysplastic syndromes
  • previously treated myelodysplastic syndromes
  • secondary myelodysplastic syndromes
  • graft versus host disease
  • childhood myelodysplastic syndromes
  • Graft vs Host Disease
  • Leukemia
  • Myelodysplastic Syndromes
  • Preleukemia

Name

Location

University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
University of Rochester Cancer CenterRochester, New York  14642
Shands Hospital and Clinics, University of FloridaGainesville, Florida  32610-100277
University of California San Diego Cancer CenterLa Jolla, California  92093-0658
Hahnemann University HospitalPhiladelphia, Pennsylvania  19102-1192
Lombardi Cancer CenterWashington, District of Columbia  20007
James Graham Brown Cancer CenterLouisville, Kentucky  40202
New York Medical CollegeValhalla, New York  10595
Massey Cancer CenterRichmond, Virginia  23298-0037
Oregon Cancer CenterPortland, Oregon  97201-3098
University of Oklahoma Health Sciences CenterOklahoma City, Oklahoma  73104
Presbyterian-St Luke's Medical CenterDenver, Colorado  80218
South Texas Cancer InstituteSan Antonio, Texas  78229
Indiana Blood and Marrow TransplantationIndianapolis, Indiana  46202