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

Primary Purpose

Acute Myeloid Leukemia, Myelodysplastic Syndromes

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
sapacitabine and decitabine (Part 1 - completed)
sapacitabine and venetoclax (Part 2 - recruiting)
Sponsored by
Cyclacel Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myeloid Leukemia focused on measuring Sapacitabine, decitabine, venetoclax, elderly, AML, MDS, Refractory, relapsed, untreated

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rush University Medical Center
  • Roswell Park Cancer Institute
  • MD Anderson Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Sapacitabine/decitabine (Part 1 - completed)

sapacitabine/venetoclax (Part 2 - recruiting)

Arm Description

decitabine will be administered in alternating cycles with sapacitabine

sapacitabine will be administered concomitantly with venetoclax

Outcomes

Primary Outcome Measures

Number of patients who achieve a clinical benefit response including CR, CRp, PR and major HI

Secondary Outcome Measures

response duration
transfusion requirements
hospitalized days
overall survival

Full Information

First Posted
September 27, 2010
Last Updated
July 12, 2019
Sponsor
Cyclacel Pharmaceuticals, Inc.
Collaborators
M.D. Anderson Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT01211457
Brief Title
Study of Sapacitabine in Acute Myeloid Leukemia (AML) or Myelodysplastic Syndromes (MDS)
Official Title
A Phase I/II Combination Study of Sapacitabine in Acute Myeloid Leukemia or Myelodysplastic Syndromes
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 17, 2010 (Actual)
Primary Completion Date
June 20, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cyclacel Pharmaceuticals, Inc.
Collaborators
M.D. Anderson Cancer Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia, Myelodysplastic Syndromes
Keywords
Sapacitabine, decitabine, venetoclax, elderly, AML, MDS, Refractory, relapsed, untreated

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
65 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sapacitabine/decitabine (Part 1 - completed)
Arm Type
Experimental
Arm Description
decitabine will be administered in alternating cycles with sapacitabine
Arm Title
sapacitabine/venetoclax (Part 2 - recruiting)
Arm Type
Experimental
Arm Description
sapacitabine will be administered concomitantly with venetoclax
Intervention Type
Drug
Intervention Name(s)
sapacitabine and decitabine (Part 1 - completed)
Intervention Description
decitabine will be administered in alternating cycles with sapacitabine
Intervention Type
Drug
Intervention Name(s)
sapacitabine and venetoclax (Part 2 - recruiting)
Intervention Description
sapacitabine will be administered concomitantly with venetoclax
Primary Outcome Measure Information:
Title
Number of patients who achieve a clinical benefit response including CR, CRp, PR and major HI
Time Frame
2 years
Secondary Outcome Measure Information:
Title
response duration
Time Frame
2 years
Title
transfusion requirements
Time Frame
2 years
Title
hospitalized days
Time Frame
2 years
Title
overall survival
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Judy H Chiao, MD
Phone
9085177330
Email
jchiao@cyclacel.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hagop M Kantarjian, MD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Completed
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Individual Site Status
Completed
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-3387
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Debra Bull - Linderman, RN
Phone
713-563-4303
Email
DLBull@mdanderson.org
First Name & Middle Initial & Last Name & Degree
Tapan M Kadia, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
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.
Results Reference
result

Learn more about this trial

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

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