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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2010-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Leukemia, Myeloid, Acute Lymphoblastic Leukemia, Acute

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Participants with AML randomized to SCH 727965

Group Type EXPERIMENTAL

SCH 727965

Intervention Type DRUG

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

Participants with AML randomized to gemtuzumab ozogamicin

Group Type ACTIVE_COMPARATOR

Gemtuzumab ozogamicin

Intervention Type DRUG

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

AML treated w/ SCH 727965 after prog. on gemtuzumab ozogamicin

Group Type EXPERIMENTAL

SCH 727965

Intervention Type DRUG

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

Participants with ALL treated with SCH 727965

Group Type EXPERIMENTAL

SCH 727965

Intervention Type DRUG

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

Interventions

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SCH 727965

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

Intervention Type DRUG

Gemtuzumab ozogamicin

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

Intervention Type DRUG

Other Intervention Names

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Mylotarg

Eligibility Criteria

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Inclusion Criteria

* For participants with AML:

* Age \>=60 years, either sex, any race.
* Diagnosis of CD33-positive AML by World Health Organization criteria.
* Must be in first or second relapse, or have primary refractory or refractory disease at first salvage, and not be considered a candidate for transplant.
* Acute promyelocytic leukemia who has relapsed following treatment with both all trans retinoic acid (tretinoin) and arsenic trioxide-based therapy is eligible.
* For participants with ALL:

* Age \>=18 years, either sex, any race.
* Diagnosis of ALL by World Health Organization criteria.
* Must be in first or second relapse, or have primary refractory or refractory disease at first salvage, and not be considered a candidate for potentially curative therapy.
* Eastern Cooperative Oncology group performance status of 0 or 1.
* Adequate hematologic, renal, and hepatic organ function and laboratory parameters.
* Receiving treatment with hydroxyurea or leukapheresis to reduce elevated white blood cell count to \<=30 x 10\^9 is eligible, provided hydroxyurea and leukapheresis are discontinued at least 24 hours before initiation of study drug.

Exclusion Criteria

* Known central nervous system leukemia.
* Previous hematopoietic stem cell transplantation.
* Previous treatment with SCH 727965 or other cyclin-dependent kinase inhibitors.
* For AML, previous treatment with gemtuzumab ozogamicin.
* Known HIV infection.
* Known active hepatitis B or C.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No