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Forodesine Hydrochloride (BCX-1777) for B-Cell Acute Lymphoblastic Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00289562
Recruitment Status : Completed
First Posted : February 10, 2006
Last Update Posted : January 20, 2012
Sponsor:
Information provided by (Responsible Party):
BioCryst Pharmaceuticals

Study Description
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Brief Summary:
A Phase I/II, Multi-Center, Open-Label, Repeat-Dose Study of Forodesine Hydrochloride Infusion in Patients with B-cell Acute Lymphoblastic Leukemia with an Option of Extended Use of Forodesine Hydrochloride

Condition or disease Intervention/treatment Phase
B-cell Acute Lymphoblastic Leukemia Drug: forodesine hydrochloride (BCX-1777) Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II, Multi-Center, Open-Label, Repeat-Dose Study of Forodesine Hydrochloride Infusion in Patients With B-Cell Acute Lymphoblastic Leukemia With an Option of Extended Use of Forodesine Hydrochloride
Study Start Date : September 2004
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

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Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Documented B-cell acute lymphoblastic leukemia (B-ALL), which under WHO Guidelines is now referred to as precursor B-lymphoblastic leukemia/lymphoma
  • Must have failed at least 1 treatment regimen for B-ALL, which under WHO Guidelines is now referred to as precursor B-lymphoblastic leukemia/lymphoma
  • Performance status of ≤2 by Eastern Cooperative Oncology Group (ECOG) criteria
  • Any age is allowed
  • Life expectancy of at least 3 months
  • Adequate liver function (aspartate transaminase [AST] and/or alanine transaminase [ALT] not >3 times upper limits of normal [ULN])
  • Adequate kidney function (calculated creatinine clearance >40 mL/min)
  • Negative serum or urine pregnancy test within 2 to 7 days prior to the start of study treatment in females of childbearing potential
  • Females of childbearing potential and males must be willing and able to use an adequate method of contraception to avoid pregnancy for the duration of the study in such a manner that the risk of pregnancy is minimized. Acceptable contraceptives include intra-uterine devices (IUDs), hormonal contraceptives (oral, depot, patch, or injectable) and double barrier methods such as condoms or diaphragms with spermicidal gel or foam.
  • Signed informed consent form (ICF), minor assent form (if applicable), prior to start of any study-specific procedures

Exclusion Criteria:

  • Active serious infection not controlled by oral or intravenous antibiotics
  • Treatment with any investigational antileukemic agent or chemotherapy agent in the last 7 days prior to study entry and lack of full recovery from side effects due to prior therapy independent of when that therapy was given
  • Rapidly progressive disease with compromised organ function judged to be life-threatening by the Investigator
  • Patients with clinical evidence of active central nervous system (CNS) disease
  • Concurrent treatment with other anticancer agents
  • Pregnant and/or lactating female
  • Patients with known human immunodeficiency virus (HIV) infection HIV testing will be performed at the Screening visit for patients who have not been tested within 6 months of receiving study drug, as well as those patients who have had exposure or have been transfused with blood products that were not appropriately screened.
  • Patients with known active hepatitis B and/or hepatitis C infection Hepatitis testing will be performed at the Screening visit for patients who have not been tested within 6 months of receiving study drug, as well as those patients who have had exposure or have been transfused with blood products that were not appropriately screened.
  • Hypersensitive or intolerant to any component of the study drug formulation
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00289562


Locations
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United States, Colorado
Denver, Colorado, United States, 80218
United States, Illinois
Chicago, Illinois, United States, 60637
United States, Kansas
Kansas City, Kansas, United States, 66160
United States, New York
New York, New York, United States, 10021
New York, New York, United States, 10029
United States, Texas
Houston, Texas, United States, 77030
United States, Virginia
Abingdon, Virginia, United States, 24211
Sponsors and Collaborators
BioCryst Pharmaceuticals
More Information
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Responsible Party: BioCryst Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00289562    
Other Study ID Numbers: BCX1777-Bi-04-106
First Posted: February 10, 2006    Key Record Dates
Last Update Posted: January 20, 2012
Last Verified: January 2012
Keywords provided by BioCryst Pharmaceuticals:
B-cell
leukemia
B-lymphoblastic leukemia
lymphoma
B-All
Additional relevant MeSH terms:
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Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
 Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases