Clinical trial · Interventional
CYC065 CDK Inhibitor and Venetoclax Study in Relapsed/Refractory CLL
A Phase I Combination Study of CYC065 and Venetoclax for Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)
NCT03739554CI-TRIAL-00073315completedPhase 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)
A Phase I Combination Study of CYC065 and Venetoclax for Relapsed or Refractory Chronic Lymphocytic Leukemia (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 |
|---|---|---|---|
| Relapsed or Refractory Chronic Lymphocytic Leukemia | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CYC065 | Drug | Fadraciclib | ALIAS |
| Venetoclax | Drug | Venetoclax | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CYC065 and venetoclax
- description
- CYC065 will be administered intravenously via 4-hour infusion on Day 1 and Day 15 after the venetoclax ramp-up schedule is completed. Venetoclax will be taken daily at a dose that is deemed safe and tolerable after the ramp-up schedule. One cycle will be 28 days or 4 weeks.
- interventionNames
- Drug: CYC065
- Drug: Venetoclax
Primary outcomes (1)
- measure
- Number of patients who experience dose-limiting toxicity (DLT)
- timeFrame
- At the end of cycle 1 (each cycle is 28 days)
Secondary outcomes (2)
- measure
- Pharmacokinetic effect
- timeFrame
- At the end of cycle 1 (each cycle is 28 days)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * CLL that is relapsed or refractory to BTK inhibitors and is on a stable dose of venetoclax * ECOG 0-2 * Adequate bone marrow function * Adequate renal function * Adequate liver function * INR \<=1.2 in patients not receiving chronic anticoagulation * At least 4 weeks from prior cytotoxic chemotherapy * At least 4 weeks from major surgery * Agree to practice effective contraception Exclusion Criteria: * Known CLL involvement in CNS that is symptomatic and active * currently receiving radiotherapy, biological therapy, or any other investigational agents * Uncontrolled intercurrent illness * Pregnant or lactating * Known to be HIV-positive * Known active hepatitis B and/or hepatitis C infection
References
Publications (0)
Data not yet available
No reference posted for this study.