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A Phase II Trial of Myeloablative Conditioning and Transplantation of HLA-matched, Partially HLA-mismatched, HLA-haploidentical or Matched Unrelated (MUD) Bone Marrow for Patients With Refractory Severe Aplastic Anemia


Phase 2
6 Months
70 Years
Open (Enrolling)
Both
Severe Aplastic Anemia

Thank you

Trial Information

A Phase II Trial of Myeloablative Conditioning and Transplantation of HLA-matched, Partially HLA-mismatched, HLA-haploidentical or Matched Unrelated (MUD) Bone Marrow for Patients With Refractory Severe Aplastic Anemia


Inclusion Criteria:



- Patients who have refractory or relapsed SAA following treatment with one or more
immunosuppressive regimens.

- Age 6 months - 70 years

- Patients must meet medical criteria for myeloablative BMT

- Patients or their parents/guardians and donors must be able to sign consent forms.

- Patients must be geographically accessible and willing to participate in all stages
of treatment.

Exclusion Criteria:

- Poor cardiac function: left ventricular ejection fraction <45% as determined by MUGA
or ECHO.

- Poor pulmonary function: FEV1 and FVC <50% predicted.

- Poor renal function

- Positive leukocytotoxic crossmatch

- Women of childbearing potential who currently are pregnant (Β-HCG+) or who are not
practicing adequate contraception

- Uncontrolled viral, bacterial, or fungal infections

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To estimate the overall survival (OS) at 1 year following HLA-matched, Partially HLA-mismatched, HLA-haploidentical or matched unrelated Bone Marrow for Patients with Refractory Severe Aplastic Anemia

Outcome Time Frame:

1 year

Safety Issue:

Yes

Principal Investigator

Robert A Brodsky, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Johns Hopkins University

Authority:

United States: Institutional Review Board

Study ID:

J10117

NCT ID:

NCT01383434

Start Date:

June 2011

Completion Date:

June 2014

Related Keywords:

  • Severe Aplastic Anemia
  • Anemia
  • Anemia, Aplastic

Name

Location
The Sidney Kimmel Comprehensive Cancer Center Baltimore, Maryland  21231