Study of CEP-701 (Lestaurtinib) in Patients With Acute Myeloid Leukemia (AML)

Acute Myeloid Leukemia Clinical Trial

Official title:

A Randomized, Open-Label Study of Oral CEP-701 Administered in Sequence With Standard Chemotherapy to Patients With Relapsed Acute Myeloid Leukemia (AML) Expressing FLT-3 Activating Mutations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00079482
• Other study ID #: C701a/204/ON/US
• Status: Completed
• Phase: Phase 2
• First received: March 8, 2004
• Last updated: July 19, 2016
• Start date: October 2003
• Est. completion date: January 2010

Study information

• Verified date: July 2016
• Source: Teva Pharmaceutical Industries
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to determine whether CEP-701 given in sequence with induction chemotherapy increases the proportion of patients with relapsed acute myeloid leukemia (AML) who achieve a second complete remission (CR).

Description:

Patients randomly assigned to chemotherapy alone received the second course of induction chemotherapy as soon as clinically indicated; patients randomly assigned to receive chemotherapy plus sequential lestaurtinib had lestaurtinib withheld for 3 days (72 hours) before the start of the second 5-day course of chemotherapy and resumed lestaurtinib treatment 2 days (48 hours) after the final administration of the second course of chemotherapy.

Other known NCT identifiers

• NCT00483340

Recruitment information / eligibility

• Status: Completed
• Enrollment: 224
• Est. completion date: January 2010
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• cytological confirmation of AML;

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

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

• aged 18 years or older;

• written informed consent;

• ability to understand and comply with study restrictions;

• no comorbid conditions that would limit life expectancy to less than 3 months;

• ECOG Performance Score of 0, 1,or 2;

• women must be neither pregnant nor lactating, and either of non-childbearing potential or using adequate contraception with a negative pregnancy test at study entry

Exclusion criteria:

• bilirubin > 2x ULN;

• ALT/AST > 3x ULN;

• serum creatinine > 1.5 mg/dL;

• resting ejection fraction of left ventricle l < 45%(applies only to patients scheduled to receive mitoxantrone, etoposide, and cytarabine [MEC];

• untreated or progressive infection;

• any physical or psychiatric cdtn that may compromise participation in the study;

• known CNS involvement with AML;

• any previous treatment with a FLT-3 inhibitor;

• requires current treatment for HIV with protease inhibitors;

• active GI ulceration or bleeding;

• use of an investigational drug that is not expected to be cleared by the start of CEP-701 treatment

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Drug:
• CEP-701

• high-dose cytarabine
Chemotherapy
• Mitozantrone, Etoposide, Cytarabine (combination Chemotherapy)
Chemotherapy

Locations

Country	Name	City	State
Australia	Call For Information	Adelaide	South Australia
Australia	Call For Information	Fitzroy	Victoria
Australia	Call for Information	Herston	Queensland
Australia	Call For Information	Melbourne	Victoria
Australia	Call For Information	Perth	Western Australia
Australia	Call For Information	South Brisbane	Queensland
Australia	Call For Information	Sydney	New South Wales
Canada	CHA Hospital Enfant-Jesus	Quebec
Canada	Princess Margaret Hospital	Toronto	Ontario
Germany	Call For Information	Chemnitz
Germany	Call For Information	Dresden
Germany	Call For Information	Frankfurt
Germany	Call For Information	Heidelberg
Germany	Call For Information	Munster
Germany	Call For Information	Stuttgart
Israel	Call For Information	Haifa
Israel	Call For Information	Petah-Tiqwa
Israel	Call For Information	Tel Hashomer
Italy	Call For Information	Bologna
Italy	Call For Information	Roma
Italy	Call For Information	Roma
Italy	Call For Information	Turin
New Zealand	Call For Information	Auckland
Poland	Call For Information	Bialystok
Poland	Call For Information	Gdansk
Poland	Call For Information	Katowice
Poland	Call For Information	Krakow
Poland	Call For Information	Lodz
Poland	Call For Information	Lublin
Poland	Call For Information	Poznan
Poland	Call For Information	Warszawa
Poland	Call For Information	Warszawa
Poland	Call For Information	Wroclaw
Romania	Call For Information	Bucharest
Romania	Call For Information	Iasi
Russian Federation	Call For Information	Moscow
Russian Federation	Call For Information	Novosibirsk
Russian Federation	Call For Information	St. Petersburg
Russian Federation	Call For Information	St. Petersburg
Spain	Call For Information	Barcelona
Spain	Call For Information	Valencia
Sweden	Call For Information	Lund
Sweden	Call For Information	Stockholm
Ukraine	Call For Information	Cherkassy
Ukraine	Call For Information	Kiev
Ukraine	Call For Information	Kiev
Ukraine	Call For Information	Lvov
United States	University of Michigan	Ann Arbor	Michigan
United States	Emory University School of Medicine	Atlanta	Georgia
United States	Johns Hopkins	Baltimore	Maryland
United States	Univeristy of Maryland Medicine - Greenebaum Cancer Center	Baltimore	Maryland
United States	St. Francis Cancer Care Services	Beech Grove	Indiana
United States	University of Alabama	Birmingham	Alabama
United States	Beth Israel Hospital	Boston	Massachusetts
United States	Tufts New England Medical Center	Boston	Massachusetts
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Northwestern University	Chicago	Illinois
United States	University of Chicago	Chicago	Illinois
United States	The Cleveland Clinic Foundation	Cleveland	Ohio
United States	Karmanos Cancer Institute Wayne State University	Detroit	Michigan
United States	Duke University Medical Center	Durham	North Carolina
United States	MD Anderson Cancer Center	Houston	Texas
United States	Indiana Cancer Pavillion	Indianapolis	Indiana
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas
United States	USC/Norris Cancer Center	Los Angeles	California
United States	ACORN-Central Georgia Hematology/Oncology	Macon	Georgia
United States	ACORN-The West Clinic	Memphis	Tennessee
United States	University of Minnesota	Minneapolis	Minnesota
United States	New York Presbyterian	New York	New York
United States	University of Nebraska	Omaha	Nebraska
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	The Mayo Clinic	Rochester	Minnesota
United States	Mayo-Scottsdale	Scottsdale	Arizona
United States	University of Washington Medical Center	Seattle	Washington
United States	LSU Shreveport	Shreveport	Louisiana
United States	Washington University	St. Louis	Missouri
United States	Stanford Medical Center	Stanford	California
United States	Moffitt Cancer Center	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Cephalon

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Germany,  Israel,  Italy,  New Zealand,  Poland,  Romania,  Russian Federation,  Spain,  Sweden,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine whether CEP-701 given in sequence with induction chemotherapy increases the proportion of patients with relapsed AML who achieve a second complete remission or a complete remission with incomplete platelet count recovery.		113 days	No
Secondary	- overall survival - event-free survival - remission duration - safety and tolerability of CEP-701 - pharmacokinetics of CEP-701 - CEP-701 inhibitory activity		113 days	Yes