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NCT00899431 · ClinicalTrials.gov registry record · Phase 2

Nonmyeloablative Stem Cell Transplantation for Chronic Lymphocytic Leukemia (CLL)

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

Terminated
Registry status
Phase 2
Development phase
39
Enrollment target

NCT00899431: Clinical Trial Phase 2 study, sponsored by M.D. Anderson Cancer Center.

NCT00899431 is a Phase 2 study that was terminated before completion, run by M.D. Anderson Cancer Center. The registered enrollment target is 39 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (71% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00899431, a Phase 2 study, was terminated before completion, sponsored by M.D. Anderson Cancer Center.

TERMINATED
Registry status
Phase 2
Development phase
39 participants
Enrollment target

Study Summary

The goal of this clinical research study is to learn if lenalidomide, when given with a stem cell transplant and chemotherapy (bendamustine, fludarabine, and rituximab), can help to control CLL. The safety of this treatment combination will also be studied.

Primary Outcome

To compare the need for immunomanipulation within 18 months after non-myeloablative allogeneic transplantation for CLL between the two combination therapies with or without lenalidomide maintenance. For this purpose, "immunomanipulation" is defined as any one of the following events: 1) Cessation of administering tacrolimus treatment with in the first 6 months after allotransplant due to persistent disease or progression. 2) Boost of donor lymphocytic infusion (DLI) administered anytime between

Interventions

  • DRUG Fludarabine
  • DRUG Rituximab
  • DRUG Lenalidomide
  • DRUG Thymoglobulin
  • PROCEDURE Stem Cell Transplantation

Trial Details

FieldValue
Enrollment Target 39 participants
Start Date 2009-05-06
Est. Completion 2018-10-07
Phase Phase 2
M.D. Anderson Cancer Center

2,692 total trials

Why NCT00899431 stopped before completion

NCT00899431 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (71% lower).

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

NCT00899431 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00899431 about?

NCT00899431 is a clinical study titled "Nonmyeloablative Stem Cell Transplantation for Chronic Lymphocytic Leukemia (CLL)". The goal of this clinical research study is to learn if lenalidomide, when given with a stem cell transplant and chemotherapy (bendamustine, fludarabine, and rituximab), can help to control CLL. The safety of this treatment combination will also be studied.

What is the current status of trial NCT00899431?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 39 participants. The study started on 2009-05-06. Estimated completion is 2018-10-07.

What interventions are being tested in trial NCT00899431?

The interventions under investigation include: Fludarabine (DRUG), Rituximab (DRUG), Lenalidomide (DRUG), Thymoglobulin (DRUG), Stem Cell Transplantation (PROCEDURE).

Who is sponsoring clinical trial NCT00899431?

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 NCT00899431's enrollment target sits among peer trials

39 1459th of 2000 higher than 534 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 NCT00899431, the US trial registry maintained by the National Library of Medicine. NCT00899431 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.