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A Phase II Trial of Hematopoietic Stem Cell Transplantation for the Treatment of Patients With Fanconi Anemia Lacking a Genotypically Identical Donor, Using a Chemotherapy Only Cytoreduction With Busulfan, Cyclophosphamide and Fludarabine


Phase 2
N/A
N/A
Open (Enrolling)
Both
Fanconi Anemia

Thank you

Trial Information

A Phase II Trial of Hematopoietic Stem Cell Transplantation for the Treatment of Patients With Fanconi Anemia Lacking a Genotypically Identical Donor, Using a Chemotherapy Only Cytoreduction With Busulfan, Cyclophosphamide and Fludarabine


We are currently recruiting patients.


Inclusion Criteria:



- Fanconi Anemia (confirmed by mitomycin C or DEB chromosomal breakage testing and one
of the following hematological diagnoses: Severe Aplastic Anemia, Myelodysplastic
Syndrome, Acute Myelogenous Leukemia

- Karnofsky or Lansy performance scale > or = to 70%.

- Must have adequate cardiac, hepatic, renal and pulmonary function.

- Must have 7/8 or 8/8 available unrelated donor.

Exclusion Criteria:

- Pregnant or breastfeeding.

- Active CNS leukemic involvement

- Active uncontrolled viral, bacterial or fungal infection

- Positive for HIV.

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 measure the incidence and quality of engraftment and hematopoietic reconstitution.

Outcome Time Frame:

1, 3, 6 and 12 months post transplant date

Safety Issue:

Yes

Principal Investigator

David A Margolis, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Medical College of Wisconsin

Authority:

United States: Food and Drug Administration

Study ID:

FA 08/89

NCT ID:

NCT01071239

Start Date:

April 2009

Completion Date:

May 2019

Related Keywords:

  • Fanconi Anemia
  • Fanconi Anemia
  • Hematopoietic stem cell transplant
  • Anemia
  • Fanconi Anemia
  • Fanconi Syndrome

Name

Location

Medical College of WisconsinMilwaukee, Wisconsin  53226