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LeukemiaNCT00900380

Studying Tissue Samples to Learn More About Drug Resistance in Patients With Acute Myeloid Leukemia

An observational study of Leukemia, run by ECOG-ACRIN Cancer Research 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 samples of tissue from patients with cancer in the laboratory may help doctors learn more about cancer and the development of drug resistance in patients. PURPOSE: This laboratory study is examining tissue samples from patients with acute myeloid leukemia to learn more about drug resistance in… Read more about this study

Who is it for?
Ages 18 to 120 years
Conditions the study is for
Leukemia
What is being tested?
flow cytometry, immunological diagnostic method and laboratory biomarker analysis
How many people
40 participants
Where
No sites listed yet
Study dates
28 Mar 2006to 30 Dec 2013
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 18 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Samples submitted for research from patients participating in E3999

DISEASE CHARACTERISTICS:

  • Cryopreserved bone marrow specimens collected from patients with acute myeloid leukemia enrolled on clinical trial ECOG-E3999 meeting the following criteria:
  • Appreciable levels of either CD34+ OR CD117+ blasts
  • Appreciable staining with anti-P-gp antibodies
  • 30 specimens must exhibit low to moderate dye loading for the Rh123 efflux assay
  • 10 specimens must exhibit positive Rh123 efflux activities

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • Not specified

About this study

Official title: Comparison of P-gp Efflux and Accumulation Assay Results With ECOG 3999 Leukemia Samples

RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about cancer and the development of drug resistance in patients.

PURPOSE: This laboratory study is examining tissue samples from patients with acute myeloid leukemia to learn more about drug resistance in these patients.

Read the detailed description

OBJECTIVES:

  • Ascertain whether assessments of P-glycoprotein (P-gp) status using the accumulation assay find greater than 10% positive specimens among 30 specimens (collected from patients with acute myeloid leukemia enrolled on clinical trial ECOG-E3999) found to be negative using only the efflux assay.

OUTLINE: This is a multicenter study.

Cryopreserved bone marrow specimens are examined for P-glycoprotein (P-gp) by the accumulation assay and the efflux assay using DiOC_2 dye. Flow cytometry is used for measuring activity in both assays.

PROJECTED ACCRUAL: A total of 40 specimens will be accrued for this study.

Conditions
Leukemia
Being tested
flow cytometry, immunological diagnostic method, laboratory biomarker analysis
Keywords
adult acute monocytic leukemia (M5b), adult acute megakaryoblastic leukemia (M7), adult acute myeloblastic leukemia with maturation (M2), adult acute myeloblastic leukemia without maturation (M1), adult acute myelomonocytic leukemia (M4), adult acute monoblastic leukemia (M5a), secondary acute myeloid leukemia, untreated adult acute myeloid leukemia, adult acute minimally differentiated myeloid leukemia (M0), adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with t(8;21)(q22;q22), adult erythroleukemia (M6a), adult pure erythroid leukemia (M6b)
Medical subject headings
Leukemia, Leukemia, Monocytic, Acute, Leukemia, Megakaryoblastic, Acute, Leukemia, Myeloid, Acute, Leukemia, Myelomonocytic, Acute, Congenital Abnormalities, Leukemia, Erythroblastic, Acute

What participants receive

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

  • flow cytometryOther

  • immunological diagnostic methodOther

  • laboratory biomarker analysisOther

What is being measured

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

  1. Percentage of specimens collected from patients that are found to be P-glycoprotein (P-gp)-positive by accumulation assay that were found to be negative using efflux assay

    Measured: 1 day

Timeline

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

  1. First posted12 May 2009 (estimated)
  2. Study start28 Mar 2006
  3. Primary completion30 Dec 2013
  4. Study completion30 Dec 2013

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
Other
Time perspective
Retrospective
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00900380
Sponsor's protocol ID
CDR0000478869
Other IDs
ECOG-E3999T1
Status last verified
May 2017
First submitted
9 May 2009
Last updated
19 May 2017
Results posted
No

Questions about this trial

What is this clinical trial studying?

An observational study of Leukemia, run by ECOG-ACRIN Cancer Research 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 19 May 2017. 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?

Percentage of specimens collected from patients that are found to be P-glycoprotein (P-gp)-positive by accumulation assay that were found to be negative using efflux assay (time frame: 1 day). 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 NCT00900380.

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 19 May 2017.

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