Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Cephalon |
---|---|
Information provided by: | Cephalon |
ClinicalTrials.gov Identifier: | NCT00079482 |
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).
Condition | Intervention | Phase |
---|---|---|
Acute Myeloid Leukemia |
Drug: lestaurtinib |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 220 |
Study Start Date: | October 2003 |
Estimated Study Completion Date: | April 2009 |
Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
Induction chemotherapy with or without sequential treatment with oral CEP-701 at 80 mg bid. For patients with duration of first CR of 1 to 6 months, the induction regimen will be MEC.
|
Drug: lestaurtinib
lestaurtinib with induction regimen of MEC
|
2: Active Comparator
Induction chemotherapy with or without sequential treatment with oral CEP-701 at 80 mg bid. For patients with duration of first CR of more than 6 months to 24 months, the induction regimen will be HiDAC.
|
Drug: lestaurtinib
lestaurtinib with induction regimen of HiDAC
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
Responsible Party: | Cephalon ( Sponsor's Medical Expert ) |
Study ID Numbers: | C701a/204/ON/US |
Study First Received: | March 8, 2004 |
Last Updated: | February 11, 2009 |
ClinicalTrials.gov Identifier: | NCT00079482 History of Changes |
Health Authority: | United States: Food and Drug Administration |
AML |
Leukemia Acute Myelocytic Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute |
Leukemia Neoplasms Neoplasms by Histologic Type Leukemia, Myeloid Leukemia, Myeloid, Acute |