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NCT00880815 · ClinicalTrials.gov registry record · Phase 1

Fludarabine, Bendamustine, and Rituximab in Treating Participants With Lymphoid Cancers Undergoing Stem Cell Transplant

A Phase 1 study of Chronic Lymphocytic Leukemia and Mantle Cell Lymphoma, sponsored by M.D. Anderson Cancer Center.

Completed
Registry status
Phase 1
Development phase
60
Enrollment target
1
Study location

NCT00880815 is a Phase 1 study of Chronic Lymphocytic Leukemia and Mantle Cell Lymphoma that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 60 participants, below the 182-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (67% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00880815, a Phase 1 study of Chronic Lymphocytic Leukemia and Mantle Cell Lymphoma, has completed, sponsored by M.D. Anderson Cancer Center.

COMPLETED
Registry status
Phase 1
Development phase
60 participants
Enrollment target
1
Study location

Study Summary

This phase I trial studies the best dose and how well bendamustine works with standard chemotherapy (fludarabine, rituximab) in treating participants with lymphoid cancers undergoing stem cell transplant. Drugs used in chemotherapy, such as fludarabine, bendamustine, and rituximab, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy before a stem cell transplant helps stop the growth of cancer cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. When the healthy stem cells from a donor are infused into the participant, they may help the participant's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes, the transplanted cells from a donor can make an immune response against the body's normal cells called graft versus host disease. Giving rituximab and methotrexate after the transplant may stop this from happening.

Interventions

  • DRUG Fludarabine
  • BIOLOGICAL Anti-Thymocyte Globulin
  • BIOLOGICAL Filgrastim
  • DRUG Bendamustine
  • PROCEDURE Allogeneic Hematopoietic Stem Cell Transplantation

Study Locations (1)

Texas

  • M D Anderson Cancer Center - Houston

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2009-02-17
Est. Completion 2019-05-28
Phase Phase 1

Sponsor

M.D. Anderson Cancer Center

2,692 total trials

What the Registry Record Tells You About NCT00880815

The ClinicalTrials.gov registry entry for NCT00880815 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 182-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (67% lower). The listed sponsor is M.D. Anderson Cancer Center, which has 2,692 total studies on file at ClinicalTrials.gov.

The record links to 7 conditions, with Chronic Lymphocytic Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Fludarabine is the first listed.

NCT00880815 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.

Frequently Asked Questions

What is clinical trial NCT00880815 about?

NCT00880815 is a clinical study titled "Fludarabine, Bendamustine, and Rituximab in Treating Participants With Lymphoid Cancers Undergoing Stem Cell Transplant". This phase I trial studies the best dose and how well bendamustine works with standard chemotherapy (fludarabine, rituximab) in treating participants with lymphoid cancers undergoing stem cell transplant. Drugs used in chemotherapy, such as fludarabine, bendamustine, and rituximab, work in different...

What is the current status of trial NCT00880815?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2009-02-17. Estimated completion is 2019-05-28.

What conditions does trial NCT00880815 study?

This clinical trial studies the following conditions: Chronic Lymphocytic Leukemia, Mantle Cell Lymphoma, Follicular Lymphoma, Marginal Zone Lymphoma, Recurrent Diffuse Large B-Cell Lymphoma.

What interventions are being tested in trial NCT00880815?

The interventions under investigation include: Fludarabine (DRUG), Anti-Thymocyte Globulin (BIOLOGICAL), Filgrastim (BIOLOGICAL), Bendamustine (DRUG), Allogeneic Hematopoietic Stem Cell Transplantation (PROCEDURE).

Who is sponsoring clinical trial NCT00880815?

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

Where is trial NCT00880815 being conducted?

This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.