Clinical trial · Interventional
TGR-1202, a PI3K Delta Inhibitor, in Combination With Obinutuzumab and Chlorambucil in Patients With Chronic Lymphocytic Leukemia (CLL)
A Multi-center Phase I/Ib Study Evaluating the Efficacy and Safety of TGR-1202, a Novel PI3K Delta Inhibitor, in Combination With Obinutuzumab and Chlorambucil in Patients With Chronic Lymphocytic Leukemia (CLL)
NCT02100852CI-TRIAL-00040965completedPhase 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)
The purpose of this study is to evaluate the safety and effectiveness of TGR-1202 in combination with obinutuzumab (Gazyva) and chlorambucil in patients with chronic lymphocytic leukemia.
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 |
|---|---|---|---|
| TGR-1202 + Obinutuzumab + Chlorambucil | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- TGR-1202 + Obinutuzumab + Chlorambucil
- description
- TGR-1202 is an oral daily dose with obinutuzumab at a fixed IV infusion and chlorambucil as an oral dose on specified days.
- interventionNames
- Drug: TGR-1202 + Obinutuzumab + Chlorambucil
Primary outcomes (1)
- measure
- Maximum Tolerated Dose acceptable for participants
- timeFrame
- 28 days (1 cycle of therapy)
- description
- To determine the incidence of adverse events, any potential abnormal laboratory results and any dose-limiting toxicities
Secondary outcomes (1)
- measure
- Overall Response Rate
- timeFrame
- Up to 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Confirmed Chronic Lymphocytic Leukemia (CLL) * Eastern Cooperative Oncology Group (ECOG) score of 0 to 2 * Ability to swallow oral medication Exclusion Criteria: * Known hepatitis B virus, hepatitis C virus or HIV infection * Primary central nervous system lymphoma or known intracranial involvement * Autologous hematologic stem cell transplant within 3 months of study entry or Allogeneic hematologic stem cell transplant within 12 months
References
Publications (0)
Data not yet available
No reference posted for this study.