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Conditioning Regimens for Patients With Severe Aplastic Anemia Transplanted With Marrow From an Unrelated Donor

Fred Hutchinson Cancer Center (FHCC) logo

Fred Hutchinson Cancer Center (FHCC)

Status and phase

Completed
Phase 2
Phase 1

Conditions

Anemia, Aplastic

Treatments

Procedure: Bone marrow transplant

Study type

Interventional

Funder types

Other

Identifiers

NCT00144729
NIH# HL36444-21
IRB# 3632
FHCRC 0800.01

Details and patient eligibility

About

A single arm dose optimization study in which all patients are given a fixed dose of Cytoxan (4 x 50 mg/kg) plus ATG (3 x 30 mg/kg) and the TBI dose starting at 3 x 200 cGy is escalated or de-escalated dependent upon engraftment and toxicity.

Sex

All

Ages

Under 55 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Life-threatening marrow failure of nonmalignant etiology;
  • failure to respond to the best available immunosuppressive treatment;
  • lack of a HLA-identical family member

Exclusion criteria

  • Severe disease other than aplastic anemia that would severly limit the probability of survival during the graft procedure;
  • HIV seropositive patients;
  • clonal abnormalities or myelodysplastic syndrome;

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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