Status:
TERMINATED
SCH 727965 in Patients With Acute Myelogenous Leukemia and Acute Lymphoblastic Leukemia (P04717AM2)(TERMINATED)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Leukemia, Myeloid, Acute
Lymphoblastic Leukemia, Acute
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 o...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT00798213
Start Date
January 1 2009
End Date
April 1 2010
Last Update
February 4 2015
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