Recruiting
Phase 1
Phase 2

Sapacitabine

Sponsor:

Cyclacel Pharmaceuticals, Inc.

Code:

NCT01211457

Conditions

Acute Myeloid Leukemia

Myelodysplastic Syndromes

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

sapacitabine and decitabine (Part 1 - completed)

sapacitabine and venetoclax (Part 2 - recruiting)

Study Details

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

Conditions

Acute Myeloid Leukemia

Myelodysplastic Syndromes

Study ID

NCT01211457

Start date

Jun 17, 2010

Status verified date

Oct, 2018

Completion date

Dec 31, 2020

Anticipated

Primary completion date

Jun 20, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

65 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Sapacitabine/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

Interventions

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Judy H Chiao, MD

9085177330jchiao@cyclacel.com

Locations

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030-3387

Contacts

Debra Bull - Linderman, RN

713-563-4303DLBull@mdanderson.org

Principal Investigator:

Tapan M Kadia, MD

More Information

Sponsor

Cyclacel Pharmaceuticals, Inc.

Last update posted

Jul 16, 2019

Last verified

Oct, 2018

Keywords

  • Sapacitabine
  • decitabine
  • venetoclax
  • elderly
  • AML
  • MDS
  • Refractory
  • relapsed
  • untreated

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Cyclacel Pharmaceuticals, Inc. on 2019-07-16.