Completed

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

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What is being tested

Leucovorin

Drug
Who is being recruted

Anemia, Refractory+4

+ Bone Marrow Diseases

+ Hematologic Diseases

See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: April 1998
See protocol details

Summary

Principal SponsorNational Institutes of Health Clinical Center (CC)
Last updated: March 4, 2008
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 1998

Actual date on which the first participant was enrolled.

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.

NCT00004997
Principal SponsorNational Institutes of Health Clinical Center (CC)
Last updated: March 4, 2008
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

14 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Anemia, RefractoryBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesAnemiaAnemia, Refractory, with Excess of BlastsMyelodysplastic Syndromes

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.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Warren G. Magnuson Clinical Center (CC)

Bethesda, United StatesOpen Warren G. Magnuson Clinical Center (CC) in Google Maps
CompletedOne Study Center