Study of Sapacitabine in Acute Myeloid Leukemia (AML) or Myelodysplastic Syndromes (MDS)

Acute Myeloid Leukemia Clinical Trial

Official title:

A Phase I/II Combination Study of Sapacitabine in Acute Myeloid Leukemia or Myelodysplastic Syndromes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01211457
• Other study ID #: CYC682-11
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: June 17, 2010
• Est. completion date: December 31, 2020

Study information

• Verified date: October 2018
• Source: Cyclacel Pharmaceuticals, Inc.
• Contact: Judy H Chiao, MD
• Phone: 9085177330
• Email: jchiao[@]cyclacel.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a combination study to evaluate sapacitabine administered in alternating cycles with decitabine in previously untreated Acute Myeloid Leukemia (AML) or concomitantly with venetoclax in previously treated AML or MDS

Description:

This is an open-label, single arm, study of sapacitabine administered in alternating cycles with decitabine in elderly patients with previously untreated AML (Part 1) or concomitantly with venetoclax in adult patients with relapsed or refractory AML or MDS (Part 2). Treatment will be administered on an outpatient basis. One treatment cycle is 4 weeks.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 65
• Est. completion date: December 31, 2020
• Est. primary completion date: June 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Newly diagnosed AML based on WHO classification (Part 1) or previously treated AML or MDS (Part 2)

• Age 70 years or older for whom the treatment of choice is low-intensity therapy by investigator assessment or who has refused intensive induction therapy recommended by investigator (Part 1); age 18 years or older (Part 2)

• ECOG performance status 0-2

• Adequate renal function

• Adequate liver function

• Able to swallow capsules

• Ability to understand and willingness to sign the informed consent form

Exclusion Criteria:

• AML is of the sub-type of acute promyelocytic leukemia or extramedullary myeloid tumor without bone marrow involvement

• Known central nervous system (CNS) involvement by leukemia

• Uncontrolled intercurrent illness including

• Known hypersensitivity to decitabine (Part 1) or venetoclax (Part 2)

• Known to be HIV-positive

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Myelodysplastic Syndromes
• Preleukemia
• Syndrome

Intervention

Drug:
• sapacitabine and decitabine (Part 1 - completed)
decitabine will be administered in alternating cycles with sapacitabine
• sapacitabine and venetoclax (Part 2 - recruiting)
sapacitabine will be administered concomitantly with venetoclax

Locations

Country	Name	City	State
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	Rush University Medical Center	Chicago	Illinois
United States	MD Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Cyclacel Pharmaceuticals, Inc.	M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

References & Publications (1)

Pooled Analysis of Elderly Patients with Newly Diagnosed AML Treated with Sapacitabine and Decitabine Administered in Alternating Cycles. Farhad Ravandi, Tapan M. Kadia, Gautam Borthakur, William G. Wierda, Stuart L. Goldberg, Meir Wetzler, Parameswaran V

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients who achieve a clinical benefit response including CR, CRp, PR and major HI		2 years
Secondary	response duration		2 years
Secondary	transfusion requirements		2 years
Secondary	hospitalized days		2 years
Secondary	overall survival		2 years

External Links

•   Pooled Analysis of Elderly Patients with Newly Diagnosed AML Treated with Sapacitabine and Decitabine Administered in Alternating Cycles.