Clinical trial NCT03739554: CYC065 CDK Inhibitor and Venetoclax Study in Relapsed/Refractory CLL
Official title: A Phase I Combination Study of CYC065 and Venetoclax for Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Relapsed or Refractory Chronic Lymphocytic Leukemia
Keywords: CYC065
CDK2/9
venetoclax
BCL-2
MCL-1
Relapsed
Refractory
chronic lymphocytic leukemia
small lymphocytic lymphoma
Lead sponsor: Cyclacel Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2018-11-14
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Three to 6 patients will be entered at a given CYC065 dose level. Dose escalation will be 33% until one out of 3 patients experienced a DLT at a given dose level. Dose escalation will continue at 25% if no additional DLT is observed; otherwise, dose escalation will be stopped. At least 6 patients will be treated at RD.
Primary purpose: TREATMENT

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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of patients who experience dose-limiting toxicity (DLT)
timeFrame: At the end of cycle 1 (each cycle is 28 days)
Secondary outcomes:
measure: Pharmacokinetic effect
timeFrame: At the end of cycle 1 (each cycle is 28 days)
measure: Pharmacodynamic effect
timeFrame: At the end of cycle 1 (each cycle is 28 days)
Other outcomes:
measure: Anti-tumor activity
timeFrame: From the date of first dose of CYC065 to 4 weeks after the last dose of CYC065
Locations:
city: Baltimore
country: United States
facility: Investigational Site
state: Maryland
city: Charlotte
country: United States
facility: Investigational Site
state: North Carolina
city: Houston
country: United States
facility: Investigational Site
state: Texas
Study officials:
affiliation: Cyclacel Pharmaceuticals, Inc.
name: Mark Kirschbaum, MD
role: STUDY_DIRECTOR
References: