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NCT00947388 · ClinicalTrials.gov registry record · Phase 1

Bendamustine Plus Alemtuzumab for Refractory Chronic Lymphocytic Leukemia (CLL)

A Phase 1 study, sponsored by Case Comprehensive Cancer Center.

Terminated
Registry status
Phase 1
Development phase
9
Enrollment target

NCT00947388: Clinical Trial Phase 1 study, sponsored by Case Comprehensive Cancer Center.

NCT00947388 is a Phase 1 study that was terminated before completion, run by Case Comprehensive Cancer Center. The registered enrollment target is 9 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00947388, a Phase 1 study, was terminated before completion, sponsored by Case Comprehensive Cancer Center.

TERMINATED
Registry status
Phase 1
Development phase
9 participants
Enrollment target

Study Summary

This phase I trial is studying the side effects and best dose of alemtuzumab when given together with bendamustine hydrochloride in treating patients with relapsed chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) that did not respond to fludarabine phosphate. Drugs used in chemotherapy, such as bendamustine hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as alemtuzumab, can also block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving bendamustine hydrochloride together with alemtuzumab may kill more cancer cells.

Primary Outcome

AEs will be graded according to the NCI CTCAE, Version 3.0.

Interventions

  • BIOLOGICAL Alemtuzumab
  • DRUG Bendamustine Hydrochloride

Trial Details

FieldValue
Enrollment Target 9 participants
Start Date 2008-11
Est. Completion 2013-03
Phase Phase 1
Case Comprehensive Cancer Center

407 total trials

Why NCT00947388 stopped before completion

NCT00947388 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower).

The record links to 0 conditions, and to 2 interventions - of which Alemtuzumab is the first listed.

NCT00947388 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00947388 about?

NCT00947388 is a clinical study titled "Bendamustine Plus Alemtuzumab for Refractory Chronic Lymphocytic Leukemia (CLL)". This phase I trial is studying the side effects and best dose of alemtuzumab when given together with bendamustine hydrochloride in treating patients with relapsed chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) that did not respond to fludarabine phosphate. Drugs used in chem...

What is the current status of trial NCT00947388?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2008-11. Estimated completion is 2013-03.

What interventions are being tested in trial NCT00947388?

The interventions under investigation include: Alemtuzumab (BIOLOGICAL), Bendamustine Hydrochloride (DRUG).

Who is sponsoring clinical trial NCT00947388?

This trial is sponsored by Case Comprehensive Cancer Center, which has 407 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00947388's enrollment target sits among peer trials

9 1955th of 2000 higher than 42 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 NCT00947388, the US trial registry maintained by the National Library of Medicine. NCT00947388 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.