Cell Samples From Patients With Leukemia | NCT01395628

Studies
Cell Samples From Patients With Leukemia

NCT01395628

Sponsor

Children's Oncology Group

Status

Completed

Last Update Posted

May 19, 2016Estimated

Enrollment

10Estimated

Phase

Not provided

Conditions

Leukemia

Interventions

in vitro sensitivity-directed chemotherapy
cell proliferation assay
fluorescence activated cell sorting
laboratory biomarker analysis
microscopy

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description
COG-AAML11B13	Other Identifier	Children's Oncology Group
AAML11B13	Other Identifier	Children's Oncology Group
NCI-2011-02863	Registry Identifier	CTRP (Clinical Trial Reporting Program)

Status Module

Record Verification Date

May 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2011

Primary Completion Date

May 2016Actual

Completion Date

Not provided

First Submitted Date

Jul 14, 2011

First Submission Date that Met QC Criteria

Jul 14, 2011

First Posted Date

Jul 15, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 17, 2016

Last Update Posted Date

May 19, 2016Estimated

Name	Class
National Cancer Institute (NCI)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory may help doctors learn more about cancer and the development of drug resistance in patients. It may also help doctors find better ways to treat cancer.

PURPOSE: This research trial is studying samples from patients with leukemia.

Detailed Description

OBJECTIVES:

Demonstrate the capability of primary human leukemia samples to survive and proliferate in the zebrafish embryo.
Confirm the anti-proliferative or toxic effects of known chemotherapeutics on the transplanted cells in vivo.
Evaluate the effect of novel anticancer drugs and/or their combinations on individual samples.

OUTLINE: This is a multicenter study.

Cryopreserved specimens are injected into the yolk sac of zebrafish embryos under anesthesia. After 1 hour of recovery at 28° C, embryos are maintained at 38° C and screened for fluorescence at the injection site. Within 48 hours post-injection, some embryos are treated with various chemotherapeutic drugs or dimethyl sulfoxide and incubated in protease solution. Proliferation of leukemia cells are monitored by live-cell microscopy. Cells with or without drug treatment are then extracted at 24 and 72 hours post-injection. Leukemia cells are counted and tested with imatinib mesylate, all-trans retinoic acid (tretinoin), cytosine arabinose, and known bioactive chemical compounds from promising drug families, such as tyrosine kinase inhibitors, antiapoptotic agents, channel modulators, and prostaglandin agonists.

Conditions Module

Conditions

Leukemia

Keywords

chronic phase chronic myelogenous leukemia
childhood acute promyelocytic leukemia (M3)
childhood acute myeloid leukemia/other myeloid malignancies
adult acute myeloid leukemia with t(8;21)(q22;q22)
adult acute myeloid leukemia with del(5q)
adult acute promyelocytic leukemia (M3)

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

10Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
in vitro sensitivity-directed chemotherapy	Drug
cell proliferation assay	Other
fluorescence activated cell sorting	Other
laboratory biomarker analysis	Other
microscopy	Other

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Primary human leukemia samples capable to survive and proliferate in the zebrafish embryo
In vivo confirmation of anti-proliferative or toxic effects of known chemotherapeutic agents on the transplanted cells
Effects of novel anticancer drugs and/or their combinations on individual samples

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

DISEASE CHARACTERISTICS:

Samples of blood and tissue cells from patients diagnosed with myeloid disease including the following subtypes:
- Chronic phase chronic myeloid leukemia (CML), to complement initial studies in the K562 CML cell line
- Acute promyelocytic leukemia (APL), to complement initial studies in the NB4 APL cell line
- Acute myeloid leukemia (AML) expressing the t(8;21)(q22;q22) translocation, which occurs in approximately 12% of pediatric AML and is associated with good prognosis
- AML expressing 5q- or monosomy 7, associated with a poor prognosis
- AML expressing the fms-like tyrosine kinase 3 internal tandem duplication (FLT3-ITD), associated with a poor prognosis

PATIENT CHARACTERISTICS:

Not specified

PRIOR CONCURRENT THERAPY:

Not specified

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

30 Years

Standard Ages

ChildAdult

Study Population

Patients diagnosed with myeloid disease.

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Jason N. Berman, MD	IWK Health Centre	Principal Investigator

Condition Browse Module

MeSH Terms

ID	Term
D007938	Leukemia
D015466	Leukemia, Myeloid, Chronic-Phase
D015473	Leukemia, Promyelocytic, Acute

Ancestor Terms

ID	Term
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D005434	Flow Cytometry
D008853	Microscopy

Ancestor Terms

ID	Term
D002469	Cell Separation
D003584	Cytological Techniques
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures

Browse Leaves

Not provided

Browse Branches

Not provided