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

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Cyclacel Pharmaceuticals, Inc.
Study ID
NCT01211457
Phase
PHASE1/PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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

Key Dates

Start date
Jun 17, 2010
Status verified
Oct 2018
Primary completion
Jun 20, 2020
Completion
Dec 31, 2020

Study Design

Enrollment
65 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

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

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

Locations (3)

FacilityCityStateZIPSite coordinators
Rush University Medical CenterChicagoIllinois60612-
Roswell Park Cancer InstituteBuffaloNew York14263-
MD Anderson Cancer CenterHoustonTexas77030-3387
Debra Bull - Linderman, RN
[email protected]
713-563-4303
Tapan M Kadia, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Chicago, IL

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
Rush University Medical Center· Chicago, ILRoswell Park Cancer Institute· Buffalo, NYMD Anderson Cancer Center· Houston, TX

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