CYC065 CDK Inhibitor and Venetoclax Study in Relapsed/Refractory CLL

Conditions

• Relapsed or Refractory Chronic Lymphocytic Leukemia

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• CYC065 — DRUG
  intravenous infusion
• Venetoclax — DRUG
  oral capsule

Study Details

A Phase I Combination Study of CYC065 and Venetoclax for Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)

Key Dates

Start date

Jan 25, 2019

Status verified

Jan 2024

Primary completion

Nov 15, 2022

Completion

Apr 27, 2023

Study Design

Enrollment

5 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: CYC065 and venetoclax
  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.

Primary Outcome Measure

Number of patients who experience dose-limiting toxicity (DLT) [ Time Frame: At the end of cycle 1 (each cycle is 28 days) ]

Locations (3)

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