NCT00289562

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Sep 2004

Typical duration for phase_1

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

February 8, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 10, 2006

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

January 20, 2012

Status Verified

January 1, 2012

Enrollment Period

3.2 years

First QC Date

February 8, 2006

Last Update Submit

January 19, 2012

Conditions

B-cell Acute Lymphoblastic Leukemia

Keywords

B-cellleukemiaB-lymphoblastic leukemialymphomaB-All

Interventions

forodesine hydrochloride (BCX-1777)DRUG

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Unknown Facility

Denver, Colorado, 80218, United States

Location

Unknown Facility

Chicago, Illinois, 60637, United States

Location

Unknown Facility

Kansas City, Kansas, 66160, United States

Location

Unknown Facility

New York, New York, 10021, United States

Location

Unknown Facility

New York, New York, 10029, United States

Location

Unknown Facility

Houston, Texas, 77030, United States

Location

Unknown Facility

Abingdon, Virginia, 24211, United States

Location

MeSH Terms

Conditions

Burkitt LymphomaLeukemiaLymphoma

Interventions

forodesine

Condition Hierarchy (Ancestors)

Epstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLymphoma, B-CellLymphoma, Non-HodgkinNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesHematologic Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 8, 2006

First Posted

February 10, 2006

Study Start

September 1, 2004

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

January 20, 2012

Record last verified: 2012-01

Locations

US(7)