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

Sponsor

BioCryst Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00289562

Collaborator

(none)

Enrollment

Locations

Duration (Months)

2.9

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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

Study Type:

Interventional

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 :

Sep 1, 2004

Actual Primary Completion Date :

Dec 1, 2007

Actual Study Completion Date :

Dec 1, 2007

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	City	State	Country	Postal Code
1	Denver	Colorado	United States	80218
2	Chicago	Illinois	United States	60637
3	Kansas City	Kansas	United States	66160
4	New York	New York	United States	10021
5	New York	New York	United States	10029
6	Houston	Texas	United States	77030
7	Abingdon	Virginia	United States	24211