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SCH 727965 in Patients With Acute Myelogenous Leukemia and Acute Lymphoblastic Leukemia (P04717AM2)(TERMINATED)

NCT00798213 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2015-02-04

No results posted yet for this study

Summary

Participants with acute myelogenous leukemia (AML) will be randomized to SCH 727965 or gemtuzumab ozogamicin. All participants with acute lymphoblastic leukemia (ALL) will receive SCH 727965. Part 1 of the study will determine the activity of SCH 727965 treatment in participants with AML and participants with ALL. Part 2 of the study will determine the activity of SCH 727965 treatment in participants with AML who experienced disease progression after standard treatment with gemtuzumab ozogamicin during Part 1.

Conditions

  • Leukemia, Myeloid, Acute
  • Lymphoblastic Leukemia, Acute

Interventions

DRUG

SCH 727965

SCH 727965 50 mg/m2 IV on Day 1 of each 21 day cycle until disease progression.

DRUG

Gemtuzumab ozogamicin

Gemtuzumab ozogamicin 9 mg/m2 IV on Day 1 and Day 15.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2010-04-30
Completion
2010-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00798213 on ClinicalTrials.gov