Pilot Phase I/II Study of Amino Acid Leucine in Treatment of Patients With Transfusion-Dependent Diamond Blackfan Anemia

NCT01362595 | Completed Phase 1 Results DMC

• 1 other identifier: 12-375B
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 11

Brief Summary

This study will determine the safety and possibility of giving the amino acid, leucine, in patients with Diamond Blackfan anemia(DBA)who are on dependent on red blood cell transfusions. The leucine is expected to produce a response in patients with DBA to the point where red blood cell production is increased. Red cell transfusions can then be less frequent or possibly discontinued. The investigators will study the side effects, if any, of giving leucine to DBA patients. Leucine levels of leucine will be obtained at baseline and during the study. The drug leucine will be provided in capsule form and taken 3 times a day for a total of 9 months.

Conditions

Diamond Blackfan Anemia; Blackfan Diamond Syndrome; DBA; Congenital Hypoplastic Anemia; Pure Red Cell Aplasia

Keywords

leucine administration; red blood cell transfusion; Diamond Blackfan anemia

Outcome Measures

Primary Outcomes (1)

• Response to Leucine in Transfusion Dependent Patients With Diamond Blackfan Anemia

  The primary outcome is the type of response observed at 9 months. Response to treatment can be one of the following: 1. Complete response (CR): Hb \> 9 gm/dL and transfusion-independence as defined in DBA 2. Partial response (PR): Hb \< 9 gm/dL and increased reticulocyte count to greater than baseline. 3. No response (NR): no change in transfusion requirements and no significant change reticulocyte count from baseline 4. Progression: worsening of disease as defined by the need for more frequent transfusions

  9 Months

Secondary Outcomes (1)

• Severe Adverse Events Attributable to Leucine

  9 months

Study Arms (1)

Leucine

OTHER

No alternative treatment arm

Drug: leucine

Interventions

leucine DRUG

Dosage of leucine will be dependent on body surface area (BSA): leucine 700 mg/m2/dose by mouth three times a day

Also known as: L-leucine

Leucine

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosed with Diamond Blackfan anemia as published in British Journal of Hematology
• transfusion dependent
• age 2 years and older
• adequate renal function
• adequate liver function
• negative B-HCG if patient is a menstruating female and documentation of adequate contraception
• signed informed consent

You may not qualify if:

• Known hypersensitivity to branched chain amino acids
• Diagnosis of an inborn error of amino acid metabolism disorder
• Prior hematopoietic stem cell transplantation
• Pregnancy, or plans to become pregnant during duration of trial

Sponsors & Collaborators

• Northwell Health: lead

Study Sites (11)

Phoenix Children's Hospital

Phoenix, Arizona, 85016, United States

Location

Stanford University Medical Center

Palo Alto, California, 94304, United States

Location

Riley Hospital for Children

Indianapolis, Indiana, 46202, United States

Location

University of Louisville

Louisville, Kentucky, 40202, United States

Location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

University of Michigan C.S. Mott Children's Hospital

Ann Arbor, Michigan, 48109, United States

Location

University of Missouri-Columbia Women's and Children's Hospital

Columbia, Missouri, 65201, United States

Location

Children's Specialty Center of Nevada

Las Vegas, Nevada, 89109, United States

Location

Cohen Children's Medical Center of New York

New Hyde Park, New York, 11040, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

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Related Links

• Diamond Blackfan Anemia Registry - a registry for patients with DBA in North America
• Daniella Maria Arturi Foundation is a family sponsored group which facilitates research for DBA.
• The DBA foundation is a family sponsored organization who raise funds for research and provides emotional support to families.

MeSH Terms

Conditions

Anemia, Diamond-Blackfan; Anemia, Hypoplastic, Congenital; Red-Cell Aplasia, Pure

Interventions

Leucine

Condition Hierarchy (Ancestors)

Anemia, Aplastic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Congenital Bone Marrow Failure Syndromes; Bone Marrow Failure Disorders; Bone Marrow Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential

Results Point of Contact

• Title: Dr. Adrianna Vlachos
• Organization: Feinstein Institutes for Medical Research

avlachos@northwell.edu

516-562-1504

Study Officials

• Adrianna Vlachos, MD

  Feinstein Institutes for Medical Research; Cohen Children's Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Principal Investigator

Study Record Dates

• First Submitted: May 20, 2011
• First Posted: May 30, 2011
• Study Start: June 1, 2013
• Primary Completion: June 30, 2018
• Study Completion: November 30, 2020
• Last Updated: December 2, 2022
• Results First Posted: December 2, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (11)