Clinical trial · Interventional
A Phase 2, Single-Arm, Open-Label Study Evaluating the Efficacy and Safety of Single Agent GS 1101 (CAL 101) as Therapy for Previously Treated Chronic Lymphocytic Leukemia
NCT01659047CI-TRIAL-00007967withdrawnPhase 2ClinicalTrials.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)
The purpose of this study is to evaluate the effect of GS-1101 on the onset, magnitude, and duration of tumor control
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 |
|---|---|---|---|
| GS-1101 | Drug | Idelalisib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- GS-1101
- description
- GS-1101 (oral; 150 mg BID)
- interventionNames
- Drug: GS-1101
Primary outcomes (6)
- measure
- Progression-free survival
- timeFrame
- 18 mon
- measure
- Patient Well-Being
- timeFrame
- 18 months
- description
- Health-related quality-of-life questionnaire
- measure
- Disease-related Biomarkers
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Participation in Study GS-US-312-0119 * Occurrence of confirmed progression of CLL while receiving single-agent ofatumumab in Study GS US 312 0119. * Permanent cessation of Study GS-US-312-0119 (single-agent ofatumumab) and no intervening or continuing therapy (including radiotherapy, chemotherapy, immunotherapy, or investigational therapy) for the treatment of CLL. * The time from permanent cessation of single-agent ofatumumab on Study GS-US-312-0119 and the initiation of GS 1101 on Study GS-US-312-0120 is no more than 12 weeks.
References
Publications (0)
Data not yet available
No reference posted for this study.