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

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

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

Study Overview

• Status: Unknown
• Conditions: Acute Myeloid Leukemia; Myelodysplastic Syndromes
• Intervention / Treatment: Drug: sapacitabine and decitabine (Part 1 - completed); Drug: sapacitabine and venetoclax (Part 2 - recruiting)

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 65
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Judy H Chiao, MD; Phone Number: 9085177330; Email: jchiao@cyclacel.com

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Completed
      • Rush University Medical Center
  • New York
    • Buffalo, New York, United States, 14263
      • Completed
      • Roswell Park Cancer Institute
  • Texas
    • Houston, Texas, United States, 77030-3387
      • Recruiting
      • MD Anderson Cancer Center
      • Contact: Debra Bull - Linderman, RN; Phone Number: 713-563-4303; Email: DLBull@mdanderson.org
      • Principal Investigator: Tapan M Kadia, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sapacitabine/decitabine (Part 1 - completed); decitabine will be administered in alternating cycles with sapacitabine	Drug: sapacitabine and decitabine (Part 1 - completed); decitabine will be administered in alternating cycles with sapacitabine
Experimental: sapacitabine/venetoclax (Part 2 - recruiting); sapacitabine will be administered concomitantly with venetoclax	Drug: sapacitabine and venetoclax (Part 2 - recruiting); sapacitabine will be administered concomitantly with venetoclax

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of patients who achieve a clinical benefit response including CR, CRp, PR and major HI	2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
overall survival	2 years
response duration	2 years
transfusion requirements	2 years
hospitalized days	2 years

Collaborators and Investigators

• Sponsor: Cyclacel Pharmaceuticals, Inc.
• Collaborators: M.D. Anderson Cancer Center
• Investigators: Study Chair: Hagop M Kantarjian, MD, M.D. Anderson Cancer Center

Publications and helpful links

General Publications

• 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 Venugopal, Karen Seiter, Judy Chiao and Hagop M. Kantarjian. Blood 2012 120:2630.

Study record dates

Study Major Dates

• Study Start (Actual): June 17, 2010
• Primary Completion (Anticipated): June 20, 2020
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: September 27, 2010
• First Submitted That Met QC Criteria: September 28, 2010
• First Posted (Estimate): September 29, 2010

Study Record Updates

• Last Update Posted (Actual): July 16, 2019
• Last Update Submitted That Met QC Criteria: July 12, 2019
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: elderly; Refractory; AML; MDS; relapsed; venetoclax; decitabine; untreated; Sapacitabine
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Disease; Bone Marrow Diseases; Hematologic Diseases; Precancerous Conditions; Syndrome; Myelodysplastic Syndromes; Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Preleukemia; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Decitabine; Venetoclax; Sapacitabine
• Other Study ID Numbers: CYC682-11

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO