Clinical trial · Interventional
A Phase I/II Study of GX15-070MS in Untreated CLL
A Multi-Center, Open-Label, Phase I/II Study of Single-Agent GX15-070MS Administered Every 2 to 3 Weeks to Patients With Previously-Treated Chronic Lymphocytic Leukemia (CLL)
NCT00600964CI-TRIAL-00014478completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- 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)
This protocol is being run to determine the best phase II dose and schedule of obatoclax in patients with previously untreated CLL.
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 |
|---|---|---|---|
| Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GX15-070MS | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- GX15-070MS
- description
- GX15-070MS at various doses and schedules
- interventionNames
- Drug: GX15-070MS
Primary outcomes (1)
- measure
- Determine the recommended Phase II dose of GX15-070MS administered as a 60-minute and/or 3-hour infusion every 2 to 3 weeks
- timeFrame
- 14 days
Secondary outcomes (1)
- measure
- Estimate the response rate of previously-treated patients with CLL at the recommended Phase II dose of GX15-070MS administered as a 60-minute and/or 3-hour infusion every 2 to 3 weeks.
- timeFrame
- 14 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed B-CLL * Previous standard systemic chemotherapy, including fludarabine. There are no limitations on additional, allowable type and amount of prior therapy. Acute toxicities from prior therapy must have resolved to ≤Grade 1 * Age ≥18 years * ECOG Performance Status ≤1 * Life expectancy of \>8 weeks Exclusion Criteria: * Patients receiving any other investigational agents (e.g., under another IND) or commercial agents or therapies administered with the intent to treat their malignancy * Patients with history of seizure disorders * Pregnant women and women who are breast feeding * HIV-positive patients receiving combination anti-retroviral therapy
References
Publications (1)
- RESULTO'Brien SM, Claxton DF, Crump M, Faderl S, Kipps T, Keating MJ, Viallet J, Cheson BD. Phase I study of obatoclax mesylate (GX15-070), a small molecule pan-Bcl-2 family antagonist, in patients with advanced chronic lymphocytic leukemia. Blood. 2009 Jan 8;113(2):299-305. doi: 10.1182/blood-2008-02-137943. Epub 2008 Oct 17. PMID 18931344