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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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B-cell Acute Lymphoblastic Leukemia

Intervention / Treatment
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* Drug: forodesine hydrochloride (BCX-1777)


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: forodesine hydrochloride (BCX-1777)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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B-cell, leukemia, B-lymphoblastic leukemia, lymphoma, B-All