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LeukemiaNCT01150656

Obatoclax Mesylate in Samples From Young Patients With Acute Myeloid Leukemia

An observational study of Leukemia, run by Children's Oncology Group.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages Up to 2 years
Conditions the study is for
Leukemia
What is being tested?
gene expression analysis, microarray analysis and protein expression analysis
How many people
50 participants
Where
No sites listed yet
Study dates
Jun 2010to May 2016
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 2 years
  • All sexes
  • No healthy volunteers
  • Child

Study population: Patients With Acute Myeloid Leukemia

DISEASE CHARACTERISTICS:

  • Diagnosis of acute myeloid leukemia (AML)
  • Cryopreserved samples from infants with AML available

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • Not specified

About this study

Official title: 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.

Read the 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.

Conditions
Leukemia
Being tested
gene expression analysis, microarray analysis, protein expression analysis, reverse transcriptase-polymerase chain reaction, western blotting
Keywords
childhood acute myeloid leukemia/other myeloid malignancies
Medical subject headings
Leukemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • gene expression analysisGenetic

  • microarray analysisGenetic

  • protein expression analysisGenetic

  • reverse transcriptase-polymerase chain reactionGenetic

  • western blottingGenetic

  • laboratory biomarker analysisOther

  • pharmacological studyOther

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Obatoclax mesylate activity

  2. Optimum in vitro combinations of obatoclax mesylate

  3. Pharmacodynamic (PD) biomarkers of activity

  4. Cell death mechanism in multiple-lineage leukemia (MLL) acute myeloid leukemia (AML)

  5. Disease progression in a xenograft model of MLL-rearranged infant AML

Secondary outcomes (4)

  1. Physical assessment (in xenograft model)

  2. Peripheral blast count reduction

  3. Apoptosis and/or ATG induction

  4. Modulation of relevant PD biomarkers

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jun 2010 (estimated)
  2. Study startJun 2010
  3. Primary completionMay 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Retrospective
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01150656
Sponsor's protocol ID
AAML10B17
Other IDs
COG-AAML10B17, NCI-2011-02239, AAML10B17
Status last verified
May 2016
First submitted
24 Jun 2010
Last updated
18 May 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Leukemia, run by Children's Oncology Group.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 May 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Obatoclax mesylate activity. The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01150656.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2016.

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