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Phase III Randomized Study of Cyclophosphamide With or Without Antithymocyte Globulin Before Bone Marrow Transplantation in Patients With Aplastic Anemia


Phase 3
N/A
59 Years
Not Enrolling
Both
Aplastic Anemia

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Trial Information

Phase III Randomized Study of Cyclophosphamide With or Without Antithymocyte Globulin Before Bone Marrow Transplantation in Patients With Aplastic Anemia


PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients are randomized to
receive cyclophosphamide IV over 60 minutes on days -5 to -2 with or without antithymocyte
globulin IV over 4 hours.

All patients then receive bone marrow over 60-120 minutes on day 0, 36 hours after the last
dose of cyclophosphamide.

Patients are followed at day 100, at 6 months, and at 1 year posttransplant.

Inclusion Criteria


PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Severe aplastic anemia with the following criteria:

Hypocellular bone marrow with cellularity less than 20%

At least 2 of the following hematologic abnormalities:

- Neutrophil count no greater than 500/mm3

- Platelet count no greater than 20,000/mm3

- Reticulocyte count no greater than 50,000/mm3

HLA-identical sibling donor available

No clonal cytogenetic abnormalities, paroxysmal nocturnal hemoglobinuria, or
myelodysplastic syndrome within 3 months of diagnosis of aplastic anemia

No congenital or constitutional aplastic anemia or Fanconi anemia

--Patient Characteristics--

Hepatic: Bilirubin less than 3 times upper limit of normal (ULN)

Renal: Creatinine less than 2 times ULN

Cardiovascular: Normal cardiac function

Other:

- No uncontrolled infection

- No severe concurrent disease

- HIV negative

- Fertile patients must use effective contraception

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment

Outcome Measure:

Graft failure, graft versus host disease, and survival

Outcome Time Frame:

Measured at Day 100, Month 6, and Year 1 post-transplant

Safety Issue:

Yes

Authority:

United States: Federal Government

Study ID:

199/14004

NCT ID:

NCT00004474

Start Date:

September 1998

Completion Date:

August 2007

Related Keywords:

  • Aplastic Anemia
  • Hematologic Disorders
  • Rare Disease
  • Anemia
  • Anemia, Aplastic

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009
Midwest Children's Cancer CenterMilwaukee, Wisconsin  53226
Medical College of WisconsinMilwaukee, Wisconsin  53226