We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu
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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01303796
Recruitment Status : Unknown
Verified September 2012 by Cyclacel Pharmaceuticals, Inc..
Recruitment status was:  Active, not recruiting
First Posted : February 25, 2011
Last Update Posted : August 19, 2015
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Drug: Sapacitabine and decitabine Drug: Decitabine Phase 3

Detailed Description:
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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 485 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III Randomized Study of Oral Sapacitabine in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia
Study Start Date : January 2011
Estimated Primary Completion Date : October 2015
Estimated Study Completion Date : November 2015

Arms and Interventions

Arm Intervention/treatment
Experimental: Arm A
Sapacitabine and decitabine
Drug: Sapacitabine and decitabine
Sapacitabine administered in alternating cycles with decitabine
Active Comparator: Arm C
Drug: Decitabine
Decitabine alone

Outcome Measures

Primary Outcome Measures :
  1. Overall survival [ Time Frame: up to 43 months ]

Secondary Outcome Measures :
  1. Complete remission with duration [ Time Frame: Up to 43 months ]
  2. Complete remission with incomplete platelet count recovery and duration [ Time Frame: up to 43 months ]
  3. Partial remission with duration [ Time Frame: up to 43 months ]
  4. Hematological improvement with duration [ Time Frame: up to 43 months ]
  5. Stable disease with duration [ Time Frame: up to 43 months ]
  6. Number of units of blood product transfused [ Time Frame: up to 43 months ]
  7. Hospitalized days [ Time Frame: up to 43 months ]
  8. 1-year survival [ Time Frame: up to 43 months ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   70 Years and older   (Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

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): NCT01303796

  Show 118 Study Locations
Sponsors and Collaborators
Cyclacel Pharmaceuticals, Inc.
Study Chair: Hagop Kantarjian, M.D. M.D. Anderson Cancer Center
More Information

Responsible Party: Cyclacel Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01303796     History of Changes
Other Study ID Numbers: CYC682-12
First Posted: February 25, 2011    Key Record Dates
Last Update Posted: August 19, 2015
Last Verified: September 2012

Keywords provided by Cyclacel Pharmaceuticals, Inc.:

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors