SCH 727965 in Patients With Acute Myelogenous Leukemia and Acute Lymphoblastic Leukemia (P04717) - Full Text View

Sponsored by:	Schering-Plough
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00798213

Purpose

The study will determine the activity of SCH 727965 treatment in patients with acute myelogenous leukemia (AML) and patients with acute lymphoblastic leukemia (ALL). The study will also determine the activity of SCH 727965 treatment in patients with AML who experience disease progression after standard treatment with gemtuzumab ozogamicin.

Condition	Intervention	Phase
Leukemia, Myeloid, Acute Lymphoblastic Leukemia, Acute	Drug: SCH 727965 Drug: Gemtuzumab ozogamicin	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	A Phase 2 Study of SCH 727965 in Subjects With Relapsed and Refractory Acute Myelogenous Leukemia and Acute Lymphoblastic Leukemia

Resource links provided by NLM:

MedlinePlus related topics: Leukemia, Adult Acute Leukemia, Adult Chronic

Drug Information available for: Gemtuzumab ozogamicin

U.S. FDA Resources

Further study details as provided by Schering-Plough:

Primary Outcome Measures:

Overall response rate of initial treatment with SCH 727965 in subjects with AML or ALL. [ Time Frame: Every 21 days for 6 weeks, and then every 6 weeks until remission or disease progression. ] [ Designated as safety issue: No ]
Overall response rate in subjects with AML treated with SCH 727965 after disease progression on comparator. [ Time Frame: Every 21 days for 6 weeks, and then every 6 weeks until remission or disease progression. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time to disease progression for initial treatment with SCH 727965 in subjects with AML or ALL. [ Time Frame: Every 21 days for 6 weeks, and then every 6 weeks until remission or disease progression. ] [ Designated as safety issue: No ]
Overall response rate and time to progression of treatment with gemtuzumab ozogamicin in subjects with AML. [ Time Frame: Every 21 days for 6 weeks, and then every 6 weeks until remission or disease progression. ] [ Designated as safety issue: No ]
Time to disease progression in subjects with AML treated with SCH 727965 after disease progression on comparator [ Time Frame: Every 21 days for 6 weeks, and then every 6 weeks until remission or disease progression. ] [ Designated as safety issue: No ]
Plasma concentration profiles of SCH 727965. [ Time Frame: Cycle 1, Cycle 2, and Cycle 3. ] [ Designated as safety issue: No ]
Safety and tolerability of SCH 727965. [ Time Frame: Assessed at each visit. ] [ Designated as safety issue: Yes ]
Bromodeoxyuridine incorporation in an ex vivo lymphocyte stimulation assay of peripheral blood lymphocytes from subjects treated with SCH 727965. [ Time Frame: Cycle 1 and Cycle 2. ] [ Designated as safety issue: No ]

Estimated Enrollment:	120
Study Start Date:	January 2009
Estimated Study Completion Date:	February 2011
Estimated Primary Completion Date:	February 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm A: Experimental Subjects with AML randomized to SCH 727965	Drug: SCH 727965 SCH 727965 50 mg/m2 IV on Day 1 of each 21 day cycle until disease progression.
Arm B: Active Comparator Subjects with AML randomized to gemtuzumab ozogamicin	Drug: Gemtuzumab ozogamicin Gemtuzumab ozogamicin 9 mg/m2 IV on Day 1 and Day 15.
Arm C: Experimental Subjects with AML treated with SCH 727965 after disease progression on gemtuzumab ozogamicin.	Drug: SCH 727965 SCH 727965 50 mg/m2 IV on Day 1 of each 21 day cycle until disease progression.
Arm D: Experimental Subjects with ALL treated with SCH 727965	Drug: SCH 727965 SCH 727965 50 mg/m2 IV on Day 1 of each 21 day cycle until disease progression.

Eligibility

Ages Eligible for Study:	60 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age >=60 years, either sex, any race.
Diagnosis of either ALL or CD33-positive AML by World Health Organization criteria.
For subjects with AML:
- Subject must be in first or second relapse, or have refractory disease, and not be considered a candidate for transplant.
- Subject with acute promyelocytic leukemia who has relapsed following treatment with both all trans retinoic acid (tretinoin) and arsenic trioxide-based therapy is eligible.
Subject with ALL must be in first or second relapse, or have refractory disease, and not be considered a candidate for potentially curative therapy.
Eastern Cooperative Oncology group performance status of 0, 1, or 2.
Adequate hematologic, renal, and hepatic organ function and laboratory parameters.
Subject 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00798213

Contacts

Contact: SP Clinical Trial Registry Call Center

1-888-772-8734

Locations

United States, Indiana
Investigational Site 2	Recruiting
Beech Grove, Indiana, United States, 46107
United States, Iowa
Investigational Site 9	Recruiting
Sioux City, Iowa, United States, 51101-1733
United States, Maryland
Investigational Site 16	Recruiting
Baltimore, Maryland, United States, 21201
United States, New York
Investigational Site 13	Recruiting
New York, New York, United States, 10021
United States, Ohio
Investigational Site 25	Recruiting
Canton, Ohio, United States, 44718
United States, Wisconsin
Investigational Site 4	Recruiting
La Crosse, Wisconsin, United States, 54601
Investigational Site 19	Recruiting
Milwaukee, Wisconsin, United States, 53226

Sponsors and Collaborators

Schering-Plough

More Information

No publications provided

Responsible Party:	Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group )
Study ID Numbers:	P04717
Study First Received:	November 25, 2008
Last Updated:	August 17, 2009
ClinicalTrials.gov Identifier:	NCT00798213 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immunoproliferative Disorders
Immunologic Factors
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Gemtuzumab
Antibodies, Monoclonal
Leukemia

Lymphatic Diseases
Antibodies
Acute Myelocytic Leukemia
Acute Myeloid Leukemia, Adult
Lymphoproliferative Disorders
Lymphoma
Acute Lymphoblastic Leukemia
Immunoglobulins

Additional relevant MeSH terms:

Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Immunoproliferative Disorders
Immunologic Factors
Immune System Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Leukemia, Myeloid

Leukemia, Myeloid, Acute
Gemtuzumab
Pharmacologic Actions
Antibodies, Monoclonal
Leukemia
Lymphatic Diseases
Neoplasms
Therapeutic Uses
Lymphoproliferative Disorders

ClinicalTrials.gov processed this record on September 10, 2009