Leukemia, Myeloid, Acute, Lymphoblastic Leukemia, Acute
Conditions
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 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.
Interventions
DRUGSCH 727965
SCH 727965 50 mg/m2 IV on Day 1 of each 21 day cycle until disease progression.
DRUGGemtuzumab ozogamicin
Gemtuzumab ozogamicin 9 mg/m2 IV on Day 1 and Day 15.
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate in participants with AML treated with SCH 727965 after disease progression on comparator. | Time to identified response or disease progression on SCH 727965 in Part 2 (approx. 5 months). |
| Overall response rate of initial treatment with SCH 727965 in subjects with AML or ALL. | Time to identified response or disease progression on SCH 727965 in Part 1 (approx. 5 months). |
Secondary
| Measure | Time frame |
|---|---|
| Time to disease progression for initial treatment with SCH 727965 in subjects with AML or ALL. | Time to identified disease progression on SCH 727965 in Part 1 (approx. 5 months). |
| Overall response rate and time to progression of treatment with gemtuzumab ozogamicin in subjects with AML. | Time to identified response or disease progression on gemtuzumab ozogamicin (approx. 5 months). |
| Time to disease progression for treatment with gemtuzumab ozogamicin in participants with AML. | Time to identified disease progression on gemtuzumab ozogamicin (approx. 5 months). |
| Time to disease progression in participants with AML treated with SCH 727965 after disease progression on gemtuzumab ozogamicin | Time to identified disease progression on SCH 727965 in Part 2 (approx. 5 months). |
Outcome results
None listed