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NCT01266083 · ClinicalTrials.gov registry record · Phase 2

WT1 Vaccine Treatment of Patients in Remission From Acute Myeloid Leukemia (AML) or Acute Lymphoblastic Leukemia (ALL)

A Phase 2 study, sponsored by Sellas Life Sciences Group.

Completed
Registry status
Phase 2
Development phase
22
Enrollment target

NCT01266083: Completed Phase 2 study, sponsored by Sellas Life Sciences Group.

NCT01266083 is a Phase 2 study that has completed, run by Sellas Life Sciences Group. The registered enrollment target is 22 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01266083, a Phase 2 study, has completed, sponsored by Sellas Life Sciences Group.

COMPLETED
Registry status
Phase 2
Development phase
22 participants
Enrollment target

Study Summary

This trial will assess the safety and efficacy of vaccination with galinpepimut-S (GPS), a WT1 peptide vaccine, in patients who are in complete remission from leukemia. Participants will receive vaccinations with GPS every 2 weeks for 10 weeks (a total of 6 vaccinations). In the absence of disease recurrence at Week 12 and if clinically stable after the first 6 vaccinations, participants may continue to receive up to six more vaccinations every month.

Primary Outcome

OS at 3 years, measured from first treatment with GPS to patient's survival status at 3 years or more

Interventions

  • BIOLOGICAL GM-CSF
  • BIOLOGICAL Galinpepimut-S
  • OTHER Montanide

Trial Details

FieldValue
Enrollment Target 22 participants
Start Date 2011-01-14
Est. Completion 2016-09-30
Phase Phase 2
Sellas Life Sciences Group

6 total trials

What the finished NCT01266083 record still lists

NCT01266083 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower).

The record links to 0 conditions, and to 3 interventions - of which GM-CSF is the first listed.

NCT01266083 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01266083 about?

NCT01266083 is a clinical study titled "WT1 Vaccine Treatment of Patients in Remission From Acute Myeloid Leukemia (AML) or Acute Lymphoblastic Leukemia (ALL)". This trial will assess the safety and efficacy of vaccination with galinpepimut-S (GPS), a WT1 peptide vaccine, in patients who are in complete remission from leukemia. Participants will receive vaccinations with GPS every 2 weeks for 10 weeks (a total of 6 vaccinations). In the absence of disease ...

What is the current status of trial NCT01266083?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 22 participants. The study started on 2011-01-14. Estimated completion is 2016-09-30.

What interventions are being tested in trial NCT01266083?

The interventions under investigation include: GM-CSF (BIOLOGICAL), Galinpepimut-S (BIOLOGICAL), Montanide (OTHER).

Who is sponsoring clinical trial NCT01266083?

This trial is sponsored by Sellas Life Sciences Group, which has 6 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01266083's enrollment target sits among peer trials

22 1790th of 2000 higher than 207 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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 NCT01266083, the US trial registry maintained by the National Library of Medicine. NCT01266083 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.