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Efficacy Study of Oral Sapacitabine to Treat Acute Myeloid Leukemia in Elderly Patients

Primary Purpose

Acute Myeloid Leukemia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Sapacitabine, Arm A
Sapacitabine, Arm B
Sapacitabine, Arm C
Sapacitabine, Arm D
sapacitabine, Arm E
sapacitabine, Arm F
Sapacitabine, Arm G
Sapacitabine, Arm H
Sapacitabine, Arm I
Sponsored by
Cyclacel Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myeloid Leukemia

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • A histologically or pathologically confirmed diagnosis of AML based on WHO classification which is previously untreated by systemic therapy or is in first relapse after achieving a complete remission to initial induction, consolidation and/or maintenance therapy or MDS with IPSS scores of intermediate -2 or higher risk risk which has been previously treated with hypomethylating agents
  • Age 70 years or older for AML and 60 years or older for MDS
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Adequate renal function defined as serum creatinine equal to or less than 1.5 x upper limit of normal (ULN)
  • Adequate liver function defined as total bilirubin or direct bilirubin equal to or less than 1.5 x ULN; alanine aminotransferase (ALT or SGPT) equal to or less than 2.5 x ULN (5 x ULN if tumor has affected the liver)
  • Life expectancy reasonably adequate for evaluating the treatment effect
  • Patient must be able to swallow capsules
  • Patients must be at least 2 weeks from prior systemic therapy, radiation therapy, major surgery, or other investigational therapy, and have recovered from clinically significant toxicities of these prior treatments
  • All men and women of reproductive potential must agree to practice effective contraception for 4 weeks prior to study entry, during the entire study period and for one month after the study unless documentation of infertility exists
  • Ability to understand and willingness to sign the informed consent form

Exclusion Criteria:

  • AML is of the sub-type of acute promyelocytic leukemia
  • Having received more than one induction systemic therapy for AML or having received a standard dose or high dose ara-C containing regimen for MDS
  • Patients with known central nervous system (CNS) involvement by leukemia
  • Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, active cancer(s) other than AML, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. Patients receiving intravenous antibiotics for infections that are under control may be included in this study
  • Known to be HIV-positive

Sites / Locations

  • University of Alabama at Birmingham
  • UCLA Division of Hematology-Oncology
  • Stanford Hospitals and Clinics
  • Winship Cancer Institute
  • Northwestern University Feinberg School of Medicine
  • Rush University Medical Center
  • University of Chicago Cancer Research Center
  • University of Nebraska Medical Center
  • The Cancer Center at Hackensack University Medical Center
  • Roswell Park Cancer Institiute
  • New York Medical College
  • Penn State Milton S. Hershey Medical Center
  • Hospital of the University of Pennsylvania
  • Vanderbilt U Medical Center
  • The University of Texas MD Anderson Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

A sapacitabine

B sapacitabine

C sapacitabine

D sapacitabine

E sapacitabine

F sapacitabine

G sapacitabine

H sapacitabine

I sapacitabine

Arm Description

200 mg b.i.d. x 7 days every 3-4 weeks

300 mg b.i.d. x 7 days every 3 - 4 weeks

400 mg b.i.d. x 3 days/week x 2 weeks every 3 - 4 weeks

200 mg b.i.d. x 7 consecutive days every 4 weeks

300 mg q.d. x 7 consecutive days every 4 weeks

300 mg b.i.d. x 3 consecutive days per week for 2 weeks every 4 weeks

200 mg b.i.d. x 7 consecutive days every 4 weeks

300 mg q.d. x 7 consecutive days every 4 weeks

100 mg q.d. x 5 consecutive days per week for 2 weeks every 4 weeks

Outcomes

Primary Outcome Measures

Survival
Percentage of patients alive for one year measured from the date of randomization

Secondary Outcome Measures

CR and CRi
Complete remission and complete remission without blood count recovery, transfusion requirements, hospitalized days and safety

Full Information

First Posted
December 23, 2007
Last Updated
March 23, 2022
Sponsor
Cyclacel Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00590187
Brief Title
Efficacy Study of Oral Sapacitabine to Treat Acute Myeloid Leukemia in Elderly Patients
Official Title
A Randomized Phase 2 Study of Oral Sapacitabine in Elderly Patients With Acute Myeloid Leukemia Previously Untreated or in First Relapse, or Previously Treated Myelodysplastic Syndromes
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
December 2007 (Actual)
Primary Completion Date
December 1, 2018 (Actual)
Study Completion Date
December 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cyclacel Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The objective is to treat elderly AML and MDS patients with sapacitabine.
Detailed Description
The main objective of this study is to learn which sapacitabine treatment is more likely to keep the cancer in check for at least one year in AML patients who are at least 70 years of age or older and in MDS patients who are at least 60 years of age.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
408 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A sapacitabine
Arm Type
Experimental
Arm Description
200 mg b.i.d. x 7 days every 3-4 weeks
Arm Title
B sapacitabine
Arm Type
Experimental
Arm Description
300 mg b.i.d. x 7 days every 3 - 4 weeks
Arm Title
C sapacitabine
Arm Type
Experimental
Arm Description
400 mg b.i.d. x 3 days/week x 2 weeks every 3 - 4 weeks
Arm Title
D sapacitabine
Arm Type
Experimental
Arm Description
200 mg b.i.d. x 7 consecutive days every 4 weeks
Arm Title
E sapacitabine
Arm Type
Experimental
Arm Description
300 mg q.d. x 7 consecutive days every 4 weeks
Arm Title
F sapacitabine
Arm Type
Experimental
Arm Description
300 mg b.i.d. x 3 consecutive days per week for 2 weeks every 4 weeks
Arm Title
G sapacitabine
Arm Type
Experimental
Arm Description
200 mg b.i.d. x 7 consecutive days every 4 weeks
Arm Title
H sapacitabine
Arm Type
Experimental
Arm Description
300 mg q.d. x 7 consecutive days every 4 weeks
Arm Title
I sapacitabine
Arm Type
Experimental
Arm Description
100 mg q.d. x 5 consecutive days per week for 2 weeks every 4 weeks
Intervention Type
Drug
Intervention Name(s)
Sapacitabine, Arm A
Other Intervention Name(s)
CYC682
Intervention Description
200 mg b.i.d. x 7 days every 3-4 weeks
Intervention Type
Drug
Intervention Name(s)
Sapacitabine, Arm B
Other Intervention Name(s)
CYC682
Intervention Description
300 mg b.i.d. x 7 days every 3 - 4 weeks
Intervention Type
Drug
Intervention Name(s)
Sapacitabine, Arm C
Other Intervention Name(s)
CYC682
Intervention Description
400 mg b.i.d. x 3 days/week x 2 weeks every 3 - 4 weeks
Intervention Type
Drug
Intervention Name(s)
Sapacitabine, Arm D
Other Intervention Name(s)
CYC682
Intervention Description
200 mg b.i.d. x 7 consecutive days every 4 weeks
Intervention Type
Drug
Intervention Name(s)
sapacitabine, Arm E
Other Intervention Name(s)
CYC682
Intervention Description
300 mg q.d. x 7 consecutive days every 4 weeks
Intervention Type
Drug
Intervention Name(s)
sapacitabine, Arm F
Other Intervention Name(s)
CYC682
Intervention Description
300 mg b.i.d. x 3 consecutive days per week for 2 weeks every 4 weeks
Intervention Type
Drug
Intervention Name(s)
Sapacitabine, Arm G
Other Intervention Name(s)
CYC682
Intervention Description
200 mg b.i.d. x 7 consecutive days every 4 weeks
Intervention Type
Drug
Intervention Name(s)
Sapacitabine, Arm H
Other Intervention Name(s)
CYC682
Intervention Description
300 mg q.d. x 7 consecutive days every 4 weeks
Intervention Type
Drug
Intervention Name(s)
Sapacitabine, Arm I
Other Intervention Name(s)
CYC682
Intervention Description
100 mg q.d. x 5 consecutive days per week for 2 weeks every 4 weeks
Primary Outcome Measure Information:
Title
Survival
Description
Percentage of patients alive for one year measured from the date of randomization
Time Frame
up to 24 months
Secondary Outcome Measure Information:
Title
CR and CRi
Description
Complete remission and complete remission without blood count recovery, transfusion requirements, hospitalized days and safety
Time Frame
From date of randomization until study withdrawal or death assessed up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: A histologically or pathologically confirmed diagnosis of AML based on WHO classification which is previously untreated by systemic therapy or is in first relapse after achieving a complete remission to initial induction, consolidation and/or maintenance therapy or MDS with IPSS scores of intermediate -2 or higher risk risk which has been previously treated with hypomethylating agents Age 70 years or older for AML and 60 years or older for MDS Eastern Cooperative Oncology Group (ECOG) performance status 0-2 Adequate renal function defined as serum creatinine equal to or less than 1.5 x upper limit of normal (ULN) Adequate liver function defined as total bilirubin or direct bilirubin equal to or less than 1.5 x ULN; alanine aminotransferase (ALT or SGPT) equal to or less than 2.5 x ULN (5 x ULN if tumor has affected the liver) Life expectancy reasonably adequate for evaluating the treatment effect Patient must be able to swallow capsules Patients must be at least 2 weeks from prior systemic therapy, radiation therapy, major surgery, or other investigational therapy, and have recovered from clinically significant toxicities of these prior treatments All men and women of reproductive potential must agree to practice effective contraception for 4 weeks prior to study entry, during the entire study period and for one month after the study unless documentation of infertility exists Ability to understand and willingness to sign the informed consent form Exclusion Criteria: AML is of the sub-type of acute promyelocytic leukemia Having received more than one induction systemic therapy for AML or having received a standard dose or high dose ara-C containing regimen for MDS Patients with known central nervous system (CNS) involvement by leukemia Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, active cancer(s) other than AML, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. Patients receiving intravenous antibiotics for infections that are under control may be included in this study Known to be HIV-positive
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hagop M Kantarjian, MD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
UCLA Division of Hematology-Oncology
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Stanford Hospitals and Clinics
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Winship Cancer Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Northwestern University Feinberg School of Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
University of Chicago Cancer Research Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Facility Name
The Cancer Center at Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Roswell Park Cancer Institiute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
New York Medical College
City
Hawthorne
State/Province
New York
ZIP/Postal Code
10532
Country
United States
Facility Name
Penn State Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Vanderbilt U Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
The University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23075701
Citation
Kantarjian H, Faderl S, Garcia-Manero G, Luger S, Venugopal P, Maness L, Wetzler M, Coutre S, Stock W, Claxton D, Goldberg SL, Arellano M, Strickland SA, Seiter K, Schiller G, Jabbour E, Chiao J, Plunkett W. Oral sapacitabine for the treatment of acute myeloid leukaemia in elderly patients: a randomised phase 2 study. Lancet Oncol. 2012 Nov;13(11):1096-104. doi: 10.1016/S1470-2045(12)70436-9. Epub 2012 Oct 15.
Results Reference
result

Learn more about this trial

Efficacy Study of Oral Sapacitabine to Treat Acute Myeloid Leukemia in Elderly Patients

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