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NCT00081874 · ClinicalTrials.gov registry record · Phase 1

RAD001 in Relapsed or Refractory AML, ALL, CML in Blastic-Phase, Agnogenic Myeloid Metaplasia, CLL, T-Cell Leukemia, or Mantle Cell Lymphoma

A Phase 1 study, sponsored by M.D. Anderson Cancer Center.

Completed
Registry status
Phase 1
Development phase
29
Enrollment target

NCT00081874: Completed Phase 1 study, sponsored by M.D. Anderson Cancer Center.

NCT00081874 is a Phase 1 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 29 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (52% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00081874, a Phase 1 study, has completed, sponsored by M.D. Anderson Cancer Center.

COMPLETED
Registry status
Phase 1
Development phase
29 participants
Enrollment target

Study Summary

The goal of this clinical research study is to find the highest safe dose of RAD001 that can be given as a treatment for leukemia, mantle cell lymphoma, or myelofibrosis. Another goal is to learn how effective the dose that is found is as a treatment.

Primary Outcome

If either 0 of 3 or 1 of 6 patients assigned to receive dose of 10 mg experiences grade 3 or 4 drug related toxicities, then this dose is the MTD. If greater than 2 patients experience grade 3 or 4 toxicities, either in the first 3 patients or in the first 6 patients, then the MTD is 5 mg.

Interventions

  • DRUG RAD001

Trial Details

FieldValue
Enrollment Target 29 participants
Start Date 2004-04
Est. Completion 2006-09
Phase Phase 1
M.D. Anderson Cancer Center

2,692 total trials

What the finished NCT00081874 record still lists

NCT00081874 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (52% lower).

The record links to 0 conditions, and to 1 intervention - of which RAD001 is the first listed.

NCT00081874 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00081874 about?

NCT00081874 is a clinical study titled "RAD001 in Relapsed or Refractory AML, ALL, CML in Blastic-Phase, Agnogenic Myeloid Metaplasia, CLL, T-Cell Leukemia, or Mantle Cell Lymphoma". The goal of this clinical research study is to find the highest safe dose of RAD001 that can be given as a treatment for leukemia, mantle cell lymphoma, or myelofibrosis. Another goal is to learn how effective the dose that is found is as a treatment.

What is the current status of trial NCT00081874?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 29 participants. The study started on 2004-04. Estimated completion is 2006-09.

What interventions are being tested in trial NCT00081874?

The interventions under investigation include: RAD001 (DRUG).

Who is sponsoring clinical trial NCT00081874?

This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00081874's enrollment target sits among peer trials

29 1440th of 2000 higher than 554 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 NCT00081874, the US trial registry maintained by the National Library of Medicine. NCT00081874 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.