CYC065 CDK Inhibitor and Venetoclax Study in Relapsed/Refractory CLL

Cyclacel Pharmaceuticals, Inc.5 enrolled

Overview

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

This is an open-label, single arm, dose escalation study in patients with relapsed or refractory CLL. Treatment will be administered on an outpatient basis and all patients will receive CYC065 over 4-hour infusion once every 2 weeks on Day 1 and Day 15 in combination with venetoclax. One treatment cycle is 4 weeks.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Relapsed or Refractory Chronic Lymphocytic Leukemia

Interventions

CYC065DRUG

intravenous infusion

VenetoclaxDRUG

oral capsule

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

Investigational Site

Baltimore, Maryland, United States

Investigational Site

Charlotte, North Carolina, United States

Investigational Site

Houston, Texas, United States

Outcomes

Primary Outcomes

Number of patients who experience dose-limiting toxicity (DLT)

Time frame: At the end of cycle 1 (each cycle is 28 days)

Secondary Outcomes

Pharmacokinetic effect

Plasma drug level

Time frame: At the end of cycle 1 (each cycle is 28 days)

Pharmacodynamic effect

MCL-1 level in peripheral white blood cells

Time frame: At the end of cycle 1 (each cycle is 28 days)

Data from ClinicalTrials.gov

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