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NCT01842139 · ClinicalTrials.gov registry record · Phase 1

Vaccine Therapy and Basiliximab in Treating Patients With Acute Myeloid Leukemia in Complete Remission

A Phase 1 study, sponsored by University of Chicago.

Completed
Registry status
Phase 1
Development phase
7
Enrollment target

NCT01842139: Completed Phase 1 study, sponsored by University of Chicago.

NCT01842139 is a Phase 1 study that has completed, run by University of Chicago. The registered enrollment target is 7 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01842139, a Phase 1 study, has completed, sponsored by University of Chicago.

COMPLETED
Registry status
Phase 1
Development phase
7 participants
Enrollment target

Study Summary

This randomized phase I trial studies the side effects and best way to give vaccine therapy together with basiliximab in treating patients with acute myeloid leukemia (AML) in complete remission. Vaccines made from the WT1 peptide may help the body build an effective immune response to kill cancer cells. Montanide ISA 51 VG and poly-ICLC may enhance this response. Monoclonal antibodies, such as basiliximab, can block cancer growth in different ways. Some block the ability of cancer to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. It is not yet known whether WT1 126-134 peptide vaccine with Montanide ISA 51 VG is more effective than with poly-ICLC when given together with basiliximab in treating AML

Primary Outcome

Evaluated by flow cytometry and using IFN-gamma ELISPOT as the primary measures. Compared using a two-sample t test.

Interventions

  • OTHER laboratory biomarker analysis
  • DRUG Montanide ISA 51 VG
  • BIOLOGICAL basiliximab
  • BIOLOGICAL WT1 126-134 peptide vaccine
  • DRUG poly ICLC

Trial Details

FieldValue
Enrollment Target 7 participants
Start Date 2011-12-05
Est. Completion 2018-03
Phase Phase 1
University of Chicago

796 total trials

What the finished NCT01842139 record still lists

NCT01842139 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (88% lower).

The record links to 0 conditions, and to 5 interventions - of which laboratory biomarker analysis is the first listed.

NCT01842139 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01842139 about?

NCT01842139 is a clinical study titled "Vaccine Therapy and Basiliximab in Treating Patients With Acute Myeloid Leukemia in Complete Remission". This randomized phase I trial studies the side effects and best way to give vaccine therapy together with basiliximab in treating patients with acute myeloid leukemia (AML) in complete remission. Vaccines made from the WT1 peptide may help the body build an effective immune response to kill cancer c...

What is the current status of trial NCT01842139?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 7 participants. The study started on 2011-12-05. Estimated completion is 2018-03.

What interventions are being tested in trial NCT01842139?

The interventions under investigation include: laboratory biomarker analysis (OTHER), Montanide ISA 51 VG (DRUG), basiliximab (BIOLOGICAL), WT1 126-134 peptide vaccine (BIOLOGICAL), poly ICLC (DRUG).

Who is sponsoring clinical trial NCT01842139?

This trial is sponsored by University of Chicago, which has 796 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01842139's enrollment target sits among peer trials

7 1972nd of 2000 higher than 27 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01842139, the US trial registry maintained by the National Library of Medicine. NCT01842139 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.