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NCT00955916 · ClinicalTrials.gov registry record · Phase 2

CLAG Gleevec in Relapsed or Refractory Acute Myeloid Leukemia (AML)

A Phase 2 study of Leukemia, sponsored by H. Lee Moffitt Cancer Center and Research Institute.

Completed
Registry status
Phase 2
Development phase
38
Enrollment target
1
Study location

NCT00955916: Completed Phase 2 study of Leukemia, sponsored by H. Lee Moffitt Cancer Center and Research Institute.

NCT00955916 is a Phase 2 study of Leukemia that has completed, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 38 participants, below the 487-participant average among 233 other Leukemia trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00955916, a Phase 2 study of Leukemia, has completed, sponsored by H. Lee Moffitt Cancer Center and Research Institute.

COMPLETED
Registry status
Phase 2
Development phase
38 participants
Enrollment target
1
Study location

Study Summary

The purpose of the study is to find out what effects (good and bad) Gleevec® (Imatinib mesylate) combined with chemotherapy has on participants and their acute myeloid leukemia.

Primary Outcome

Overall Response Rate: Morphologic Complete Remission (CR) + Morphologic Complete Remission with incomplete blood count recovery (CRi) for evaluable participants. CR - Bone Marrow: \< 5% blasts without Auer rods with at least 20% cellularity with maturation of all cell lines, No presence of unique phenotype by flow cytometry identical to what was found in the pretreatment specimen, No persistent dysplasia; Peripheral: normal blood counts, absolute neutrophil count (ANC) \> 1.0 k/μl and platelets

Conditions Studied

Interventions

  • DRUG CLAG Regimen
  • DRUG Gleevec®

Study Locations (1)

Florida

  • H. Lee Moffitt Cancer Center and Research Institute - Tampa

Trial Details

FieldValue
Enrollment Target 38 participants
Start Date 2009-08
Est. Completion 2014-05
Phase Phase 2

What the finished NCT00955916 record still lists

NCT00955916 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 487-participant average among 233 other Leukemia trials with a reported enrollment target (92% lower).

The record links to 1 condition, with Leukemia appearing as the primary indexed condition, and to 2 interventions - of which CLAG Regimen is the first listed.

NCT00955916 reports a single indexed study location in Florida.

Frequently Asked Questions

What is clinical trial NCT00955916 about?

NCT00955916 is a clinical study titled "CLAG Gleevec in Relapsed or Refractory Acute Myeloid Leukemia (AML)". The purpose of the study is to find out what effects (good and bad) Gleevec® (Imatinib mesylate) combined with chemotherapy has on participants and their acute myeloid leukemia.

What is the current status of trial NCT00955916?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 38 participants. The study started on 2009-08. Estimated completion is 2014-05.

What conditions does trial NCT00955916 study?

This clinical trial studies the following conditions: Leukemia.

What interventions are being tested in trial NCT00955916?

The interventions under investigation include: CLAG Regimen (DRUG), Gleevec® (DRUG).

Who is sponsoring clinical trial NCT00955916?

This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00955916 being conducted?

This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Leukemia

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00955916's enrollment target sits among peer trials

38 143rd of 233 higher than 90 of 233 other Leukemia trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Leukemia 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 NCT00955916, the US trial registry maintained by the National Library of Medicine. NCT00955916 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.