A research study for patients with acute myeloid leukemia (AML) in first relapse

Phase 3

• Conditions: Acute Myeloid Leukemia; Cancer - Leukaemia - Acute leukaemia

• Registration Number: ACTRN12606000514505
• Lead Sponsor: Vion Pharmaceuticals, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-12-12
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 420

Inclusion Criteria

Patients must have AML (any WHO classification excluding acute promyelocytic leukemia) in first relapse after a first CR (complete response) or CRp (meeting all criteria for CR except recovery of platelet counts to >100,000 uL) determined by bone marrow aspirates and/or biopsies that contain = 10% blasts. The duration of first CR or CRp must have been at least 3 months but less than 24 months, calculated from the day CR or CRp was documented following the initial induction regimen to the day leukemia relapse was confirmed by recurrence of blasts in peripheral blood, bone marrow histopathology and/or histological proven central nervous system (CNS) or extramedullary disease.

Exclusion Criteria

Uncontrolled active infection of any kind. Presence of any other severe medical condition that may compromise the safety of treatment.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint is overall response (CR and CRp) rate (ORR). <br>CRp is defined as meeting all criteria for CR except recovery of platelet counts to >100,000 uL.[After treatment, patients will be seen at least once weekly with at least twice weekly labs until a CR or CRp, or non-response/ progression is documented.]

Secondary Outcome Measures

Name	Time	Method
Time-to-progression or death from any cause; duration of response; survival; and toxicity.[All patients enrolled in the study will enter a follow-up phase after study completion/early withdrawal. For patients who respond, data regarding disease status will be collected until recurrence for up to 3 years. Data regarding survival will also be collected for up to 3 years. Follow-up evaluations are recommended every 3 months. End of study will be defined as 3 years following enrolment of the last study patient.]