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Study Summary
No. 2003-0719:.......Leukemia......Farhad Ravandi-Kashani......Leukemia
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Study Summary Title
Study Summary
Number:		2003-0719
Study Title:A Randomized Study of Oral CEP-701 Administered in Sequence with Standard Chemotherapy to Patients with Relapsed Acute Myeloid Leukemia (AML) Expressing FLT-3 Mutations
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Physician New Patient Referral
Name:Farhad Ravandi-KashaniPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:LeukemiaReferring MD
Call:		800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-792-7305
Contact us about clinical trials
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General Information
Disease Group:LeukemiaSupported By:N/A
Phase of Study:Phase IIReturn
Visit:		Weekly during first 8 weeks, then every two weeks up to 18 weeks.
Treatment
Agents:		CEP-701
Cytarabine
Etoposide
Mitoxantrone		Home Care:CEP-701 may be given at home.
Treatment Loc:Independent Multicenter Arrangements
Estimated
Length of Stay
in Houston:		The total length of study is 16 weeks plus 2 weeks follow-up, with additional
follow-up every two months via phone or visit for up to two years.
Description/
Intervention:		The goal of this clinical research study is to learn if CEP -701 given after
chemotherapy can help to control AML.The safety of giving CEP-701 following
chemotherapy will be studied. The level of CEP-701 in the blood and the
activity of the drug will also be studied.
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Study Objectives / Outcomes
The primary objective of the study is to determine whether CEP-701 treatment given in
sequence with induction chemotherapy increases the proportion of patients with relapsed
AML who achieve a second CR or a CR with incomplete platelet count recovery (CRp).
The secondary objectives of the study are to determine the following:
  • overall survival
  • event-free survival
  • remission duration (for patients who achieve a CR or a CRp [CR/CRp])
  • the proportion of patients who achieve an outcome of CR, CRp, or partial remission (PR)
  • the proportion of patients who maintain an outcome of CR/CRp up to day 113
  • the proportion of patients who achieve an outcome of CR/CRp after crossing over to treatment with CEP-701
  • the safety and tolerability of CEP-701 treatment administered in sequence with chemotherapy throughout the study
  • the pharmacokinetics of CEP-701 treatment at specified time points
  • CEP-701 inhibitory activity in plasma by means of a FLT-3 ex vivo bioassay and cell assay at specified time points
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Study Status Information
Study Activation / Registration Date:12/31/2003
IRB Review and Approval Date:11/05/2003
Study Type:Therapeutic
Recruitment Status:Terminated
Projected Accrual:220
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.
Inclusion Criteria:1) cytological confirmation of AML

2) relapsed disease following first CR of duration 1 month (30 days) to 24 months (730 days). The time from first relapse to study entry (start of first course of induction chemotherapy) must be no longer than 30 days.

3) confirmation of FLT-3 activating mutation positive status after point of initial relapse

4) aged 18 years and older

5) written informed consent

6) ability to understand and comply with study restrictions

7) no co-morbid conditions that would limit life expectancy to less than 3 months

8) Eastern Cooperative Oncology Group (ECOG) performance score of 0, 1, or 2

9) women must be neither pregnant or lactating, and either of non-childbearing potential or using adequate contraception with a negative pregnancy test at study entry
Exclusion Criteria:1) bilirubin levels greater than 2 times ULN, alanine transaminase or aspartate transaminase levels greater than 3 times ULN

2) serum creatinine concentrations greater than 1.5 mg/dL

3) resting ejection fraction of left ventricle less than 45% (applies only to patients scheduled to receive mitoxantrone, etoposide, and cytarabine [MEC])

4) untreated or progressive infection

5) any physical or psychiatric condition that may compromise participation in the study

6) known central nervous system involvement with AML

7) any prior treatment with a FLT-3 inhibitor

8) patient requires current treatment for the human immunodeficiency virus (HIV) with protease inhibitors

9) active gastrointestinal ulceration or bleeding

10) use of an investigational drug that is not expected to be cleared by the start of CEP-701 treatment
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Links
Registration Number: NCT00079482
Study Information on Clinical Trials Registry (clinicaltrials.gov)
Other Links:
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Results

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