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NCT00427791 · ClinicalTrials.gov registry record · Phase 2

Rituximab to the Preparative Regimen of Etoposide and Total Body Irradiation in Acute Lymphoblastic Leukemia

A Phase 2 study, sponsored by M.D. Anderson Cancer Center.

Completed
Registry status
Phase 2
Development phase
23
Enrollment target

NCT00427791: Completed Phase 2 study, sponsored by M.D. Anderson Cancer Center.

NCT00427791 is a Phase 2 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 23 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

NCT00427791, a Phase 2 study, has completed, sponsored by M.D. Anderson Cancer Center.

COMPLETED
Registry status
Phase 2
Development phase
23 participants
Enrollment target

Study Summary

Primary Objective: * To determine the progression free survival (PFS) of the preparative regimen rituximab, etoposide and total body irradiation (TBI), in patients with acute lymphoblastic leukemia (ALL) receiving allogeneic hematopoietic stem cell transplantation (SCT). Secondary Objectives: * To determine the effect of rituximab on the incidence of acute graft vs. host disease (GVHD). * To determine the efficacy of adding imatinib mesylate post transplant in ALL patients with the t(9;22)(q34;q11) cytogenetic abnormality. * To estimate the probability of molecular complete remission at one year for the described treatment approach as determined by serial minimal residual disease (MRD) monitoring. * To determine the rate of GVHD, engraftment, toxicity, and overall survival (OS) for this treatment regimen.

Primary Outcome

Time from randomization to first progression or death, whichever comes first, measured in months.

Interventions

  • DRUG Rituximab
  • DRUG Etoposide
  • RADIATION Total Body Irradiation

Trial Details

FieldValue
Enrollment Target 23 participants
Start Date 2005-07
Est. Completion 2009-10
Phase Phase 2
M.D. Anderson Cancer Center

2,692 total trials

What the finished NCT00427791 record still lists

NCT00427791 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 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 Rituximab is the first listed.

NCT00427791 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00427791 about?

NCT00427791 is a clinical study titled "Rituximab to the Preparative Regimen of Etoposide and Total Body Irradiation in Acute Lymphoblastic Leukemia". Primary Objective: * To determine the progression free survival (PFS) of the preparative regimen rituximab, etoposide and total body irradiation (TBI), in patients with acute lymphoblastic leukemia (ALL) receiving allogeneic hematopoietic stem cell transplantation (SCT). Secondary Objectives: * T...

What is the current status of trial NCT00427791?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 23 participants. The study started on 2005-07. Estimated completion is 2009-10.

What interventions are being tested in trial NCT00427791?

The interventions under investigation include: Rituximab (DRUG), Etoposide (DRUG), Total Body Irradiation (RADIATION).

Who is sponsoring clinical trial NCT00427791?

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 NCT00427791's enrollment target sits among peer trials

23 1784th of 2000 higher than 211 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 NCT00427791, the US trial registry maintained by the National Library of Medicine. NCT00427791 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.