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The Experimental Treatment of Transfusion Dependent 5q Minus Syndrome With Leucovorin


Phase 2
N/A
N/A
Not Enrolling
Both
5q Minus Syndrome, Myelodysplastic Syndrome

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Trial Information

The Experimental Treatment of Transfusion Dependent 5q Minus Syndrome With Leucovorin


The objective of this protocol is to determine whether leucovorin treatment can normalize
hematopoietic cell growth and differentiation in patients with 5q- syndrome which may lack
the gene for dihydrofolate reductase enzyme.

Inclusion Criteria


All patients 18 years old and older with RA, RARS and RAEB who have a 5q deletion as their
sole cytogenetic abnormality who require transfusion support with blood defined as needing
at least one unit of packed red blood cells per month for greater than or equal to 2
months and/or thrombocytopenia defined as a platelet count less than 50,000, and/or severe
neutropenia (absolute neutrophil count less than 500) are eligible, including patients
that had been treated with chemotherapy or experimental agents such as retinoids,
phenylbutyrate, amifostine, Vitamin D, ATG or hematopoietic growth factors.

Patients must not be transforming to acute leukemia (greater than 20% blasts in marrow
aspirate).

Patients must not have had treatment with growth factors or any other experimental drug
within 4 weeks prior to entry on protocol.

Patients must not have an ECOG performance status greater than 2.

Patients must not have an active uncontrolled infection.

No patients for whom bone marrow transplant is indicated as primary therapy.

Must be able to give informed consent.

Patients must not be HIV positive.

Patients must not be pregnant.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment

Authority:

United States: Federal Government

Study ID:

980101

NCT ID:

NCT00004997

Start Date:

April 1998

Completion Date:

July 2002

Related Keywords:

  • 5q Minus Syndrome
  • Myelodysplastic Syndrome
  • Hematopoietic
  • DHFR Enzyme
  • Anemia
  • Folic Acid
  • MDS
  • Myelodysplasia
  • Myelodysplastic
  • Myelodysplastic Syndromes
  • Preleukemia

Name

Location

Warren G. Magnuson Clinical Center (CC)Bethesda, Maryland  20892