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Unrelated Bone Marrow Transplantation With Cyclophosphamide and Total Body Irradiation For Hematologic Malignancies and Bone Marrow Failure States


Phase 2
17 Years
60 Years
Not Enrolling
Both
Leukemia, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Diseases

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Trial Information

Unrelated Bone Marrow Transplantation With Cyclophosphamide and Total Body Irradiation For Hematologic Malignancies and Bone Marrow Failure States


OBJECTIVES:

- Study the curative potential of high-dose cyclophosphamide and total-body irradiation
followed by rescue with bone marrow from volunteer HLA-matched donors in patients with
a variety of hematologic malignancies and bone marrow failure states.

- Study the toxic effects associated with matched unrelated bone marrow transplantation
in this patient population.

- Participate in collaborative research studies with the National Marrow Donor Program.

OUTLINE: All patients receive myeloablative therapy with high-dose cyclophosphamide and
total body irradiation over 4 days; patients with severe aplastic anemia also receive
antithymocyte globulin. Patients then undergo allogeneic bone marrow transplantation.
Filgrastim (G-CSF) is given after transplant to accelerate engraftment. Sargramostim
(GM-CSF) may be given in case of graft failure.

All patients receive graft-versus-host-disease (GVHD) prophylaxis with tacrolimus,
methotrexate, and gamma globulin. Established GVHD is treated with corticosteroids and, as
necessary, antithymocyte globulin.

Patients are followed at 100 days, 6 months, and 1 year after transplant, then annually
thereafter.

PROJECTED ACCRUAL: A total of 10 patients per year will be accrued for this study over 5
years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- One of the following hematologic malignancies/disorders:

- Acute lymphoblastic leukemia

- In second or subsequent complete remission (CR)

- In first CR with high-risk features (e.g., Philadelphia
chromosome-positive)

- In first relapse and failed conventional salvage therapy

- Acute myelogenous leukemia (AML)

- In second or subsequent CR

- In early first relapse

- In full first relapse and failed conventional salvage therapy

- In first CR with high-risk features, e.g., trisomy 8 or FAB 6/7

- Standard-risk AML offered conventional-dose consolidation chemotherapy
or autologous bone marrow transplantation

- Chronic myelogenous leukemia in chronic, accelerated, or second chronic phase

- No blast crisis

- Severe aplastic anemia that has failed at least 1 course of immunosuppressive
therapy

- Paroxysmal nocturnal hemoglobinuria with high-risk features (e.g., disseminated
intravascular coagulation, thrombotic events)

- Myelodysplastic syndrome, i.e.:

- Symptomatic, transfusion-dependent refractory anemia with excess blasts

- (RAEB) or RAEB in transformation

- Secondary leukemia in CR following conventional-dose induction chemotherapy

- Unrelated marrow donor available who is 8 out of 10-, 9 out of 10-, or 10 out of
10-antigen serologically HLA-matched at A, B, C, DRb, and DQB loci by molecular
typing

- No CNS malignancy

PATIENT CHARACTERISTICS:

Age:

- 17 to 60

Performance status:

- Karnofsky 70-100%

Life expectancy:

- No reduction due to other serious illness

Hematopoietic:

- Not specified

Hepatic:

- Bilirubin less than 3 mg/dL

- AST/ALT no greater than twice normal

Renal:

- Creatinine no greater than 2.0 mg/dL

- Creatinine clearance greater than 60 mL/min

Cardiovascular:

- Left ventricular ejection fraction at least 45%

- No severe hypertension

Pulmonary:

- DLCO, FEV_1, and FVC at least 50%

Other:

- HIV negative

- No active infection at time of transplant

- No advanced diabetes

- No significant neurologic deficit

- No active drug or substance abuse

- No emotional disorders

- Able to participate in frequent medical care for at least 1-2 years

- Willing to comply with National Marrow Donor Program policies

PRIOR CONCURRENT THERAPY:

Biologic therapy

- See Disease Characteristics

Chemotherapy

- See Disease Characteristics

Endocrine therapy

- Not specified

Radiotherapy

- Not specified

Surgery

- Not specified

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Kenneth F. Mangan, MD, FACP

Investigator Role:

Study Chair

Investigator Affiliation:

Fox Chase Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000064937

NCT ID:

NCT00002809

Start Date:

August 1996

Completion Date:

December 2003

Related Keywords:

  • Leukemia
  • Myelodysplastic Syndromes
  • Myelodysplastic/Myeloproliferative Diseases
  • recurrent adult acute myeloid leukemia
  • recurrent adult acute lymphoblastic leukemia
  • refractory chronic lymphocytic leukemia
  • chronic phase chronic myelogenous leukemia
  • accelerated phase chronic myelogenous leukemia
  • adult acute myeloid leukemia in remission
  • adult acute lymphoblastic leukemia in remission
  • refractory anemia
  • refractory anemia with excess blasts
  • refractory anemia with excess blasts in transformation
  • secondary acute myeloid leukemia
  • previously treated myelodysplastic syndromes
  • atypical chronic myeloid leukemia
  • myelodysplastic/myeloproliferative disease, unclassifiable
  • 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
  • adult acute myeloid leukemia with t(15;17)(q22;q12)
  • Leukemia
  • Myelodysplastic Syndromes
  • Preleukemia
  • Myeloproliferative Disorders
  • Myelodysplastic-Myeloproliferative Diseases

Name

Location
Fox Chase-Temple Cancer Center Philadelphia, Pennsylvania  19111-2442