Clinical trial · Interventional
Repeat-Dose of Forodesine Hydrochloride (BCX-1777) Infusion in Patients With Advanced T-Cell Leukemia
A Phase II, Multi-Center Open-Label, Repeat-Dose of Forodesine Hydrochloride (BCX-1777) Infusion in Patients With Advanced T-Cell Leukemia With an Option of Long-Term Forodesine Hydrochloride (BCX-1777) Use
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
BCX-1777 may stop the growth of cancer cells by blocking the enzymes necessary for their growth. The Phase II trial is designed to study the effectiveness of BCX-1777 in treating patients who have recurrent or refractory advanced T-cell leukemia. Patients will receive an infusion of BCX-1777 on days 1-5. Treatment may be repeated every week for up to six courses. Patients are not required to be hospitalized for the administration of BCX-1777. Some patients may continue to receive an infusion of BCX-1777 twice a week for 6 weeks.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia, T-Cell | Leukemia | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| forodesine hydrochloride (BCX-1777) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Determine the sustained effectiveness of IV forodesine hydrochloride infusions in patients with advanced T-cell leukemia (T-ALL or T-PLL)
Secondary outcomes (3)
- measure
- Safety and tolerability
- measure
- Pharmacokinetics (PK) and Pharmacodynamics (PD)
- measure
- maintenance of response and safety in long-term treatment
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Documented T-cell leukemia (precursor T-lymphoblastic leukemia/lymphomia or T-PLL) * Failure to have responded to one or more standard regimens for their disease. * Performance status of \<=2 by Eastern Cooperative Oncology Group (ECOG) criteria * All ages are eligible * Life expectancy of at least 3 months * Adequate liver function (aspartate transaminase \[AST\] and/or alanine transaminase \[ALT\] not \>3 times upper limits or normal \[ULN\]) * Adequate kidney function (calculated creatinine clearance \>50 mL/min) * Negative urine pregnancy test within 2 to 7 days prior to the start of study treamtment 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 * Signed informed consent/assent form (ICF) prior to start of any study specific procedures Exclusion Criteria: * Patients with known HIV infection or human T-cell leukemia virus type (HTLV-1) * Patients with known Hepatitis B and/or Hepatitis C active infection * Patients with active CMV infection * Tumor-related central nervous system (CNS) leukemia requiring active treatment * Active serious infection not controlled by oral or IV antibiotics * Treatment with any investigational anti-leukemic agent or chemotherapy agent within 7 days prior to study entry, unless full recovery from side effects has occurred. * Rapidly progressive disease with compromised organ function judged to be life-threatening by the investigator * Concurrent treatment with other anticancer agents (corticosteroid use will not be excluded, but patient must remain on the stable dose) * Cutaneous T-cell lymphoma (CTCL) diagnosis (including Sezary Syndrome) * Pregnant and/or lactating women
References
Publications (0)
Data not yet available