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

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ClinicalTrials.gov Identifier: NCT01211457
Recruitment Status : Recruiting
First Posted : September 29, 2010
Last Update Posted : July 16, 2019
Sponsor:
Collaborator:
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
Cyclacel Pharmaceuticals, Inc.

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

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Myelodysplastic Syndromes Drug: sapacitabine and decitabine (Part 1 - completed) Drug: sapacitabine and venetoclax (Part 2 - recruiting) Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 65 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Combination Study of Sapacitabine in Acute Myeloid Leukemia or Myelodysplastic Syndromes
Actual Study Start Date : June 17, 2010
Estimated Primary Completion Date : June 20, 2020
Estimated Study Completion Date : December 31, 2020


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




Primary Outcome Measures :
  1. Number of patients who achieve a clinical benefit response including CR, CRp, PR and major HI [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. response duration [ Time Frame: 2 years ]
  2. transfusion requirements [ Time Frame: 2 years ]
  3. hospitalized days [ Time Frame: 2 years ]
  4. overall survival [ Time Frame: 2 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01211457


Contacts
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Contact: Judy H Chiao, MD 9085177330 jchiao@cyclacel.com

Locations
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United States, Illinois
Rush University Medical Center Completed
Chicago, Illinois, United States, 60612
United States, New York
Roswell Park Cancer Institute Completed
Buffalo, New York, United States, 14263
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030-3387
Contact: Debra Bull - Linderman, RN    713-563-4303    DLBull@mdanderson.org   
Principal Investigator: Tapan M Kadia, MD         
Sponsors and Collaborators
Cyclacel Pharmaceuticals, Inc.
M.D. Anderson Cancer Center
Investigators
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Study Chair: Hagop M Kantarjian, MD M.D. Anderson Cancer Center

Additional Information:
Publications of Results:
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.

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Responsible Party: Cyclacel Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01211457     History of Changes
Other Study ID Numbers: CYC682-11
First Posted: September 29, 2010    Key Record Dates
Last Update Posted: July 16, 2019
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Cyclacel Pharmaceuticals, Inc.:
Sapacitabine
decitabine
venetoclax
elderly
AML
MDS
Refractory
relapsed
untreated
Additional relevant MeSH terms:
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Venetoclax
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Preleukemia
Myelodysplastic Syndromes
Syndrome
Disease
Pathologic Processes
Neoplasms by Histologic Type
Neoplasms
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Decitabine
Sapacitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors