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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Acute Myeloid Leukemia	Drug: sapacitabine; Drug: Sapacitabine	Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	300 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
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 Start Date :	December 2007
Estimated Primary Completion Date :	November 2011

Arms and Interventions

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Arm	Intervention/treatment
Experimental: A	Drug: sapacitabine; 200 mg b.i.d. x 7 days every 3-4 weeks
Experimental: B	Drug: sapacitabine; 300 mg b.i.d. x 7 days every 3 - 4 weeks
Experimental: C	Drug: sapacitabine; 400 mg b.i.d. x 3 days/week x 2 weeks every 3 - 4 weeks
Experimental: Arm D	Drug: sapacitabine; 200 mg b.i.d. x 7 consecutive days every 4 weeks
Experimental: Arm E	Drug: sapacitabine; 300 mg q.d. x 7 consecutive days every 4 weeks
Experimental: Arm F	Drug: sapacitabine; 300 mg b.i.d. x 3 consecutive days per week for 2 weeks every 4 weeks
Experimental: Arm G	Drug: sapacitabine; 200 mg b.i.d. x 7 consecutive days every 4 weeks
Experimental: Arm H	Drug: Sapacitabine; 300 mg q.d. x 7 consecutive days every 4 weeks
Experimental: Arm I	Drug: sapacitabine; 100 mg q.d. x 5 consecutive days per week for 2 weeks every 4 weeks

Outcome Measures

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Primary Outcome Measures :

1. Survival [ Time Frame: one year ]

Secondary Outcome Measures :

1. Rate and duration of complete remission and complete remission without blood count recovery, transfusion requirements, hospitalized days and safety [ Time Frame: during study ]

Eligibility Criteria

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Ages Eligible for Study:	60 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Locations

United States, Alabama
University of Alabama at Birmingham	Recruiting
Birmingham, Alabama, United States, 35294
Contact: Amy Valdmanis 205-975-9481
Principal Investigator: James Foran, M.D.
United States, California
UCLA Division of Hematology-Oncology	Recruiting
Los Angeles, California, United States, 90095
Contact: Rose Malone 310-794-0242
Principal Investigator: Gary Schiller, M.D.
Stanford Hospitals and Clinics	Completed
Stanford, California, United States, 94305
United States, Connecticut
Nowalk Hospital	Withdrawn
Norwalk, Connecticut, United States, 06856
United States, Georgia
Winship Cancer Institute	Recruiting
Atlanta, Georgia, United States, 30322
Contact: Christine Hergert 404-778-1822
Principal Investigator: Martha Arellano, M.D.
United States, Illinois
Northwestern University Feinberg School of Medicine	Recruiting
Chicago, Illinois, United States, 60611
Contact: Mary Beth Riley 312-695-1379
Principal Investigator: Jessica Altman, M.D.
Rush University Medical Center	Recruiting
Chicago, Illinois, United States, 60612
Contact: Jodi Palonis 312-942-3327
Principal Investigator: Parameswaran Venugopal, M.D.
University of Chicago Cancer Research Center	Recruiting
Chicago, Illinois, United States, 60637
Contact: Margaret Green, RN 773-702-0267
Principal Investigator: Wendy Stock, M.D.
United States, Nebraska
University of Nebraska Medical Center	Recruiting
Omaha, Nebraska, United States, 68198
Contact: Rose Solberg, RN 402-559-4810
Principal Investigator: Lori Maness, M.D.
United States, New Jersey
The Cancer Center at Hackensack University Medical Center	Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Sora Limor 201-336-8598
Principal Investigator: Stuart Goldberg, M.D.
United States, New York
Roswell Park Cancer Institiute	Recruiting
Buffalo, New York, United States, 14263
Contact: Laurie Forde, RN 716-845-8360
Principal Investigator: Meir Wetzler, M.D.
New York Medical College	Recruiting
Hawthorne, New York, United States, 10532
Contact: Muhammad Rasul 914-594-4400 ext 110
Principal Investigator: Karen Seiter, M.D.
United States, Pennsylvania
Penn State Milton S. Hershey Medical Center	Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Tara Nisbet 717-531-0003 ext 285453
Principal Investigator: David Claxton, M.D.
Hospital of the University of Pennsylvania	Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Melissa Potuzak 215-662-7383
Principal Investigator: Selina Luger, M.D.
United States, Tennessee
Vanderbilt U Medical Center	Recruiting
Nashville, Tennessee, United States, 37232
Contact: Violeta Vartic 615-343-1467
Principal Investigator: Madan Jagasia, M.D.
United States, Texas
The University of Texas MD Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030-4009
Contact: Patricia Boone, RN 713-792-9191
Principal Investigator: Hagop Kantarjian, M.D.

Sponsors and Collaborators

Cyclacel Pharmaceuticals, Inc.

Investigators

Study Director:	Judy H. Chiao, M.D.	Cyclacel Pharmaceuticals, Inc.

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Cyclacel Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00590187 History of Changes
Other Study ID Numbers:	CYC682-06
First Posted:	January 10, 2008
Last Update Posted:	November 9, 2011
Last Verified:	November 2011

Additional relevant MeSH terms:

Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Neoplasms by Histologic Type; Neoplasms