NCT01211457

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
65

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jun 2010

Longer than P75 for phase_1

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 17, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 27, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 29, 2010

Completed
9.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

July 16, 2019

Status Verified

October 1, 2018

Enrollment Period

10 years

First QC Date

September 27, 2010

Last Update Submit

July 12, 2019

Conditions

Acute Myeloid LeukemiaMyelodysplastic Syndromes

Keywords

SapacitabinedecitabinevenetoclaxelderlyAMLMDSRefractoryrelapseduntreated

Outcome Measures

Primary Outcomes (1)

  • Number of patients who achieve a clinical benefit response including CR, CRp, PR and major HI

    2 years

Secondary Outcomes (4)

  • response duration

    2 years

  • transfusion requirements

    2 years

  • hospitalized days

    2 years

  • overall survival

    2 years

Study Arms (2)

Sapacitabine/decitabine (Part 1 - completed)

EXPERIMENTAL

decitabine will be administered in alternating cycles with sapacitabine

Drug: sapacitabine and decitabine (Part 1 - completed)

sapacitabine/venetoclax (Part 2 - recruiting)

EXPERIMENTAL

sapacitabine will be administered concomitantly with venetoclax

Drug: sapacitabine and venetoclax (Part 2 - recruiting)

Interventions

sapacitabine and decitabine (Part 1 - completed)DRUG

decitabine will be administered in alternating cycles with sapacitabine

Sapacitabine/decitabine (Part 1 - completed)
sapacitabine and venetoclax (Part 2 - recruiting)DRUG

sapacitabine will be administered concomitantly with venetoclax

sapacitabine/venetoclax (Part 2 - recruiting)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Rush University Medical Center

Chicago, Illinois, 60612, United States

COMPLETED

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

COMPLETED

MD Anderson Cancer Center

Houston, Texas, 77030-3387, United States

RECRUITING

Related Publications (1)

  • Pooled Analysis of Elderly Patients with Newly Diagnosed AML Treated with Sapacitabine and Decitabine Administered in Alternating Cycles. Farhad Ravandi, Tapan M. Kadia, Gautam Borthakur, William G. Wierda, Stuart L. Goldberg, Meir Wetzler, Parameswaran Venugopal, Karen Seiter, Judy Chiao and Hagop M. Kantarjian. Blood 2012 120:2630.

    RESULT

MeSH Terms

Conditions

Leukemia, Myeloid, AcuteMyelodysplastic SyndromesRecurrence

Interventions

sapacitabineDecitabinevenetoclax

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesBone Marrow DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AzacitidineAza CompoundsOrganic ChemicalsCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosides

Study Officials

  • Hagop M Kantarjian, MD

    M.D. Anderson Cancer Center

    STUDY CHAIR

Central Study Contacts

Judy H Chiao, MD

CONTACT

9085177330jchiao@cyclacel.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2010

First Posted

September 29, 2010

Study Start

June 17, 2010

Primary Completion

June 20, 2020

Study Completion

December 31, 2020

Last Updated

July 16, 2019

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

US(3)