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NCT00941928 · ClinicalTrials.gov registry record · Phase 2

Haploidentical Natural Killer (NK) Cells With Epratuzumab for Relapsed Acute Lymphoblastic Leukemia (ALL)

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

Terminated
Registry status
Phase 2
Development phase
2
Enrollment target

NCT00941928: Clinical Trial Phase 2 study, sponsored by M.D. Anderson Cancer Center.

NCT00941928 is a Phase 2 study that was terminated before completion, run by M.D. Anderson Cancer Center. The registered enrollment target is 2 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00941928, a Phase 2 study, was terminated before completion, sponsored by M.D. Anderson Cancer Center.

TERMINATED
Registry status
Phase 2
Development phase
2 participants
Enrollment target

Study Summary

The goal of this clinical research study is to learn if transferring the donor's NK cells, in combination with an antibody called epratuzumab and low-dose interleukin (IL-2), into your body can be done safely. Researchers want to find out if the infused NK cells will survive after the infusion and if the NK cell infusion helps to destroy cancer cells in the recipient's body and possibly to help control the disease. Primary Objectives: · Evaluate the feasibility of collecting an adequate number of natural killer (NK) cells from a donor and evaluate the safety of a haploidentical donor-derived NK cell infusion, Epratuzumab, and low-dose interleukin-2 (IL-2). Secondary Objectives: * Quantification and persistence of the infused donor NK cell in vivo; * Quantification and persistence of cytokine levels; * Assessment of NK cell immunophenotype and function; * Correlate above with anti-tumor effect.

Primary Outcome

TTP calculated as average time, in months, from baseline to participants disease progression or death, monitored for a minimum of 1 year

Interventions

  • DRUG Cyclophosphamide
  • DRUG Fludarabine
  • DRUG Mesna
  • DRUG Epratuzumab
  • PROCEDURE Infusion of NK cells

Trial Details

FieldValue
Enrollment Target 2 participants
Start Date 2009-07
Est. Completion 2012-05
Phase Phase 2
M.D. Anderson Cancer Center

2,692 total trials

Why NCT00941928 stopped before completion

NCT00941928 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower).

The record links to 0 conditions, and to 5 interventions - of which Cyclophosphamide is the first listed.

NCT00941928 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00941928 about?

NCT00941928 is a clinical study titled "Haploidentical Natural Killer (NK) Cells With Epratuzumab for Relapsed Acute Lymphoblastic Leukemia (ALL)". The goal of this clinical research study is to learn if transferring the donor's NK cells, in combination with an antibody called epratuzumab and low-dose interleukin (IL-2), into your body can be done safely. Researchers want to find out if the infused NK cells will survive after the infusion and i...

What is the current status of trial NCT00941928?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 2 participants. The study started on 2009-07. Estimated completion is 2012-05.

What interventions are being tested in trial NCT00941928?

The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Mesna (DRUG), Epratuzumab (DRUG), Infusion of NK cells (PROCEDURE).

Who is sponsoring clinical trial NCT00941928?

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 NCT00941928's enrollment target sits among peer trials

2 2001st of 2000 the lowest 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 NCT00941928, the US trial registry maintained by the National Library of Medicine. NCT00941928 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.