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NCT02538965 · ClinicalTrials.gov registry record · Phase 2

A Study of Lenalidomide in Pediatric Subjects With Relapsed or Refractory Acute Myeloid Leukemia

A Phase 2 study, sponsored by Celgene.

Completed
Registry status
Phase 2
Development phase
17
Enrollment target

NCT02538965: Completed Phase 2 study, sponsored by Celgene.

NCT02538965 is a Phase 2 study that has completed, run by Celgene. The registered enrollment target is 17 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02538965, a Phase 2 study, has completed, sponsored by Celgene.

COMPLETED
Registry status
Phase 2
Development phase
17 participants
Enrollment target

Study Summary

To determine the activity of lenalidomide in the treatment of pediatric subjects with relapsed/refractory acute myeloid leukemia (AML) (with second or greater relapse or refractory to at least 2 prior induction attempts) measured by morphological complete response defined as either a CR or CRi within the first 4 cycles of treatment.

Primary Outcome

The morphological complete response rate was defined as the total number of participants with morphological CR observed within the first 4 cycles of lenalidomide (regardless of whether the CR/CRi was observed at the end of Cycle 1, 2, 3 or 4) over the total number of participants evaluable for this endpoint. According to Modified IWG criteria, morphologic CR was defined as: 1. Absolute neutrophil count (ANC) ≥ 1000/μL and platelets ≥ 100,000 without transfusions and/or exogenous growth factor s

Interventions

  • DRUG Lenalidomide

Trial Details

FieldValue
Enrollment Target 17 participants
Start Date 2015-11-19
Est. Completion 2019-01-11
Phase Phase 2
Celgene

308 total trials

What the finished NCT02538965 record still lists

NCT02538965 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (87% lower).

The record links to 0 conditions, and to 1 intervention - of which Lenalidomide is the first listed.

NCT02538965 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02538965 about?

NCT02538965 is a clinical study titled "A Study of Lenalidomide in Pediatric Subjects With Relapsed or Refractory Acute Myeloid Leukemia". To determine the activity of lenalidomide in the treatment of pediatric subjects with relapsed/refractory acute myeloid leukemia (AML) (with second or greater relapse or refractory to at least 2 prior induction attempts) measured by morphological complete response defined as either a CR or CRi withi...

What is the current status of trial NCT02538965?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 17 participants. The study started on 2015-11-19. Estimated completion is 2019-01-11.

What interventions are being tested in trial NCT02538965?

The interventions under investigation include: Lenalidomide (DRUG).

Who is sponsoring clinical trial NCT02538965?

This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02538965's enrollment target sits among peer trials

17 1903rd of 2000 higher than 93 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 NCT02538965, the US trial registry maintained by the National Library of Medicine. NCT02538965 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.