Completed PHASE2 INTERVENTIONAL 2-arm NCT00079482

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

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

Sponsor: Cephalon

Conditions Acute Myeloid Leukemia

Interventions CEP-701 Mitozantrone, Etoposide, Cytarabine (combination Chemotherapy) high-dose cytarabine

Updated 10 times since 2017 Last updated: Jul 19, 2016 Started: Oct 31, 2003 Primary completion: Mar 31, 2009 Completion: Jan 31, 2010

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE2 trial investigates Acute Myeloid Leukemia and is currently completed. Cephalon leads this study, which shows 10 recorded versions since 2003 — indicating substantial longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.

Study Description(click to expand)

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.

Status Flow

Change History

10 versions recorded

Jan 2026 — Present [monthly]

Completed PHASE2
Sep 2025 — Present [monthly]

Completed PHASE2
Sep 2024 — Sep 2025 [monthly]

Completed PHASE2
Jul 2024 — Sep 2024 [monthly]

Completed PHASE2
Apr 2022 — Jul 2024 [monthly]

Completed PHASE2

▶ Show 5 earlier versions

Jan 2022 — Apr 2022 [monthly]

Completed PHASE2
Jan 2021 — Jan 2022 [monthly]

Completed PHASE2
Jun 2018 — Jan 2021 [monthly]

Completed PHASE2
Feb 2017 — Jun 2018 [monthly]

Completed PHASE2
Jan 2017 — Feb 2017 [monthly]

Completed PHASE2

First recorded

Oct 2003

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Cephalon

Data source: Teva Branded Pharmaceutical Products R&D, Inc.

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Adelaide, Australia , Ann Arbor, United States , Atlanta, United States , Auckland, New Zealand , Baltimore, United States , Barcelona, Spain , Beech Grove, United States , Bialystok, Poland , Birmingham, United States , Bologna, Italy and 64 more locations