- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01150656
Obatoclax Mesylate in Samples From Young Patients With Acute Myeloid Leukemia
SCOR in Targeted Therapies for Infant Leukemias Project 2: Targeting Apoptosis in Leukemia in Infants
RATIONALE: Studying the effects of obatoclax mesylate in cell samples from patients with cancer in the laboratory may help doctors learn more about the effects of obatoclax mesylate on cancer cells. It may also help doctors identify biomarkers related to cancer.
PURPOSE: This research study is studying obatoclax mesylate in samples from young patients with acute myeloid leukemia.
Study Overview
Status
Conditions
Detailed Description
OBJECTIVES:
- Determine comprehensive gene and protein expression profiles of in vitro sensitivity and resistance to obatoclax mesylate in multiple-lineage leukemia (MLL)-rearranged cell lines and primary infant acute myeloid leukemia (AML) samples.
- Define optimum in vitro combinations of obatoclax mesylate targeting pro-survival BCL-2 family proteins with cytotoxic drugs in MLL-rearranged leukemia cell lines and primary infant AML samples.
- Identify synergistic combinations based on a pharmacodynamic modeling and simulation construct.
- Determine whether combinations of obatoclax mesylate targeting pro-survival BCL-2 family proteins with cytotoxic drugs improves survival in a xenograft model of MLL-rearranged infant AML.
OUTLINE: This is a multicenter study.
Obatoclax mesylate activity is assessed via the MTT assay. A priori features of acute myeloid leukemia (AML) blasts relating to the apoptosis and ATG cell death pathways and their execution are characterized using microarray analysis and quantitative real-time (Q-RT) PCR. Gene and protein expression is described and quantified using Q-RT PCR and western blot analysis at specific time points after obatoclax mesylate exposure to identify pharmacodynamic biomarkers of activity and characterize the cell death mechanism in multiple-lineage leukemia (MLL)+ AML. The MTT assay is performed using obatoclax mesylate-cytotoxic chemotherapy combinations to determine synergy focusing on common cytotoxic drugs employed in AML treatment regimens.
Obatoclax mesylate efficacy is tested in a therapeutic NOG xenograft model of primary MLL+ infant AML.
Study Type
Enrollment (Anticipated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
DISEASE CHARACTERISTICS:
- Diagnosis of acute myeloid leukemia (AML)
- Cryopreserved samples from infants with AML available
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- Not specified
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Obatoclax mesylate activity
|
Optimum in vitro combinations of obatoclax mesylate
|
Pharmacodynamic (PD) biomarkers of activity
|
Cell death mechanism in multiple-lineage leukemia (MLL) acute myeloid leukemia (AML)
|
Disease progression in a xenograft model of MLL-rearranged infant AML
|
Secondary Outcome Measures
Outcome Measure |
---|
Physical assessment (in xenograft model)
|
Peripheral blast count reduction
|
Apoptosis and/or ATG induction
|
Modulation of relevant PD biomarkers
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Carolyn A. Felix, MD, Children's Hospital of Philadelphia
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AAML10B17 (Other Identifier: Children's Oncology Group)
- COG-AAML10B17 (Other Identifier: Children's Oncology Group)
- NCI-2011-02239 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Leukemia
-
Stanford UniversityTerminatedLeukemia | Leukemia, Lymphocytic, Acute | Leukemia Acute Promyelocytic Leukemia (APL) | Leukemia Acute Lymphoid Leukemia (ALL) | Leukemia Chronic Myelogenous Leukemia (CML) | Leukemia Acute Myeloid Leukemia (AML) | Leukemia Chronic Lymphocytic Leukemia (CLL)United States
-
Massachusetts General HospitalCelgene CorporationTerminatedAcute Myelogenous Leukemia | Acute Myeloid Leukemia (AML) | Acute Myelocytic Leukemia | Acute Granulocytic Leukemia | Acute Non-Lymphocytic LeukemiaUnited States
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedChildhood Acute Monoblastic Leukemia (M5a) | Childhood Acute Monocytic Leukemia (M5b) | Childhood Acute Myeloblastic Leukemia Without Maturation (M1) | Childhood Acute Myelomonocytic Leukemia (M4) | Childhood Acute Myeloid Leukemia/Other Myeloid MalignanciesUnited States
-
Institute of Hematology & Blood Diseases HospitalBejing Institute for Stem Cell and Regenerative Medicine; Institute for Stem...RecruitingRefractory Leukemia | Relapsed Leukemia | Acute Myeloid Leukemia, ChildhoodChina
-
Hybrigenics CorporationUnknownAcute Myelogenous LeukemiaUnited States, France
-
Betta Pharmaceuticals Co., Ltd.Not yet recruitingAcute Myeloid Leukemia LeukemiaChina
-
Beijing Boren HospitalRecruitingAcute Myeloid Leukemia | Refractory Acute Myeloid Leukemia | Relapse LeukemiaChina
-
Center for International Blood and Marrow Transplant...National Marrow Donor Program; St. Baldrick's FoundationActive, not recruitingAcute Myelogenous LeukemiaUnited States
-
Massachusetts General HospitalCompleted
-
Kinex Pharmaceuticals Inc.CompletedAcute Myelogenous LeukemiaUnited States
Clinical Trials on gene expression analysis
-
Southwest Oncology GroupNational Cancer Institute (NCI); Eastern Cooperative Oncology GroupCompleted
-
Renmin Hospital of Wuhan UniversityNot yet recruitingStage III Colorectal CancerChina
-
Children's Oncology GroupNational Cancer Institute (NCI)Completed
-
Children's Oncology GroupNational Cancer Institute (NCI)Completed
-
Children's Oncology GroupNational Cancer Institute (NCI)Completed
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)UnknownOvarian Cancer | Fallopian Tube Cancer | Peritoneal Cavity Cancer
-
Children's Oncology GroupNational Cancer Institute (NCI)Completed
-
The Christie NHS Foundation TrustUnknownSarcoma | Cervical Cancer | Breast Cancer | Ovarian Cancer | Fallopian Tube Cancer | Prostate Cancer | Vulvar Cancer | Endometrial Cancer | Vaginal Cancer | Primary Peritoneal Cavity CancerUnited Kingdom
-
Children's Oncology GroupNational Cancer Institute (NCI)Completed
-
Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI)Active, not recruiting