CYC065 CDK Inhibitor and Venetoclax Study in Relapsed/Refractory AML or MDS

Cyclacel Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: AML; MDS

Treatments: Drug: CYC065; Drug: Venetoclax

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04017546

CYC065-03

Details and patient eligibility

About

A Phase I Combination Study of CYC065 and Venetoclax for Relapsed or Refractory AML or MDS

Full description

This is an open-label, single arm, dose escalation study in patients with relapsed or refractory AML or MDS. 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.

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Previously treated AML or MDS based on WHO classification and having at least 10% blasts in peripheral blood
• ECOG 0-2
• Adequate renal function
• Adequate liver function
• INR <=1.2 in patients not receiving chronic anticoagulation
• At least 2 weeks from prior cytotoxic chemotherapy, radiation therapy, major surgery or other investigational cancer therapy
• Agree to practice effective contraception

Exclusion criteria

• AML is of the subtype of APL or extramedullary myeloid tumor without bone marrow involvment
• Known AML 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

CYC065 and venetoclax

Experimental group

Description:

CYC065 will be administered intravenously via 4-hour infusion on Day 1 and Day 15. Venetoclax will be taken daily on Day 1 through Day 15. One cycle will be 28 days or 4 weeks.

Treatment:

Drug: Venetoclax

Drug: CYC065