Trial record 1 of 1 for:    CYC-682-12
Previous Study | Return to List | Next Study

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by Cyclacel Pharmaceuticals, Inc.
Sponsor:
Information provided by (Responsible Party):
Cyclacel Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01303796
First received: February 21, 2011
Last updated: March 25, 2014
Last verified: September 2012

February 21, 2011
March 25, 2014
January 2011
October 2014   (final data collection date for primary outcome measure)
Overall survival [ Time Frame: up to 43 months ] [ Designated as safety issue: Yes ]
Overall survival [ Time Frame: up to 39 months ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01303796 on ClinicalTrials.gov Archive Site
  • Complete remission with duration [ Time Frame: Up to 43 months ] [ Designated as safety issue: Yes ]
  • Complete remission with incomplete platelet count recovery and duration [ Time Frame: up to 43 months ] [ Designated as safety issue: Yes ]
  • Partial remission with duration [ Time Frame: up to 43 months ] [ Designated as safety issue: Yes ]
  • Hematological improvement with duration [ Time Frame: up to 43 months ] [ Designated as safety issue: Yes ]
  • Stable disease with duration [ Time Frame: up to 43 months ] [ Designated as safety issue: Yes ]
  • Number of units of blood product transfused [ Time Frame: up to 43 months ] [ Designated as safety issue: No ]
  • Hospitalized days [ Time Frame: up to 43 months ] [ Designated as safety issue: Yes ]
  • 1-year survival [ Time Frame: up to 43 months ] [ Designated as safety issue: Yes ]
  • Complete remission with duration [ Time Frame: Up to 39 months ] [ Designated as safety issue: Yes ]
  • Complete remission with incomplete platelet count recovery and duration [ Time Frame: up to 39 months ] [ Designated as safety issue: Yes ]
  • Partial remission with duration [ Time Frame: up to 39 months ] [ Designated as safety issue: Yes ]
  • Hematological improvement with duration [ Time Frame: up to 39 months ] [ Designated as safety issue: Yes ]
  • Stable disease with duration [ Time Frame: up to 39 months ] [ Designated as safety issue: Yes ]
  • Number of units of blood product transfused [ Time Frame: up to 39 months ] [ Designated as safety issue: No ]
  • Hospitalized days [ Time Frame: up to 39 months ] [ Designated as safety issue: Yes ]
  • 1-year survival [ Time Frame: up to 39 months ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
A Study of Oral Sapacitabine in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia
A Phase III Randomized Study of Oral Sapacitabine in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia

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.

This is a multicenter, randomized, Phase 3 study comparing two drug regimens (arms) as the front-line treatment of elderly patients aged 70 years or older with newly diagnosed acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy. In Arm A, sapacitabine is administered in alternating cycles with decitabine, and in Arm C decitabine is administered alone. The primary efficacy endpoint is overall survival. The study is designed to demonstrate an improvement in overall survival of Arm A versus Arm C.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Acute Myeloid Leukemia
  • Drug: Sapacitabine and decitabine
    Sapacitabine administered in alternating cycles with decitabine
  • Drug: Decitabine
    Decitabine alone
  • Experimental: Arm A
    Sapacitabine and decitabine
    Intervention: Drug: Sapacitabine and decitabine
  • Active Comparator: Arm C
    Decitabine
    Intervention: Drug: Decitabine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
485
April 2015
October 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Newly diagnosed AML based on WHO classification
  • 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
  • ECOG performance status 0-2
  • Adequate renal function
  • Adequate liver function
  • Able to swallow capsules
  • Agree to practice effective contraception
  • 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
  • Having received any systemic anti-cancer therapy for AML or received treatment with hypomethylating agents or cytotoxic chemotherapy for the preceding MDS or MPD
  • Known or suspected central nervous system (CNS) involvement by leukemia
  • Uncontrolled intercurrent illness
  • Known hypersensitivity to decitabine
  • Known to be HIV-positive
Both
70 Years and older
No
Contact: Judy H Chiao, MD 908-517-7330 jchiao@cyclacel.com
United States
 
NCT01303796
CYC682-12
Yes
Cyclacel Pharmaceuticals, Inc.
Cyclacel Pharmaceuticals, Inc.
Not Provided
Study Chair: Hagop Kantarjian, M.D. M.D. Anderson Cancer Center
Cyclacel Pharmaceuticals, Inc.
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP