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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00144729

Enrollment

Registered

2005-09-05

Start date

1993-05-31

Completion date

2007-07-31

Last updated

2008-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia, Aplastic

Brief summary

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.

Interventions

PROCEDUREBone marrow transplant

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

No minimum to 55 Years

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;

Design outcomes

Primary

Measure	Time frame
Sustained engraftment; survival	—

Secondary

Measure	Time frame
Acute and chronic GVHD	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026