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A Study of Oral Sapacitabine in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia

NCT01303796 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 482

Last updated 2022-06-22

Study results available
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Summary

This Phase 3 study assesses two drug regimens as the initial treatment of patients who are at least 70 years of age and have newly diagnosed acute myeloid leukemia (AML) for whom the doctor does not recommend the use of standard intensive treatment or the patient has decided not to receive standard intensive treatment after being fully informed about its benefits and risks by his/her doctor. The two drug regimens are sapacitabine administered in alternating cycles with decitabine or decitabine alone. The purpose of the study is to learn which drug regimen is more likely to keep AML in check as long as possible.

Conditions

Interventions

DRUG

Sapacitabine

Oral sapacitabine capsules

DRUG

Decitabine

Decitabine intravenous

Sponsors & Collaborators

  • Cyclacel Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Hagop M Kantarjian, M.D. · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-01
Primary Completion
2016-12-15
Completion
2017-07-31
FDA Drug
Yes

Countries

  • United States
  • Austria
  • Belgium
  • France
  • Germany
  • Hungary
  • Italy
  • Poland
  • Spain
  • Sweden
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01303796 on ClinicalTrials.gov