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NCT04022239 · ClinicalTrials.gov registry record · Phase 1

Bendamustine With or Without Cyclophosphamide in Preventing GVHD in Patients Undergoing Stem Cell Transplant

A Phase 1 study of Hematopoietic and Lymphoid System Neoplasm, sponsored by M.D. Anderson Cancer Center.

Recruiting
Registry status
Phase 1
Development phase
25
Enrollment target
1
Study location

NCT04022239 is a Phase 1 study of Hematopoietic and Lymphoid System Neoplasm that is actively recruiting participants, run by M.D. Anderson Cancer Center. The registered enrollment target is 25 participants, below the 1,358-participant average among 31 other Hematopoietic and Lymphoid System Neoplasm trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT04022239, a Phase 1 study of Hematopoietic and Lymphoid System Neoplasm, is actively recruiting participants, sponsored by M.D. Anderson Cancer Center.

RECRUITING
Registry status
Phase 1
Development phase
25 participants
Enrollment target
1
Study location

Study Summary

This phase I/II trial studies the side effects and best dose of bendamustine when given with or without cyclophosphamide in preventing graft versus host disease (GVHD) in patients undergoing stem cell transplant. Drugs used in chemotherapy, such as bendamustine and cyclophosphamide, 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 and total body irradiation before or after a stem cell transplant helps kills cancer cells that are in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. Sometimes, the transplanted cells from a donor can attack the body's normal cells called GVHD. Giving tacrolimus, mycophenolate mofetil, and filgrastim after the transplant may stop this from happening.

Conditions Studied

Hematopoietic and Lymphoid System Neoplasm

Interventions

  • DRUG Cyclophosphamide
  • DRUG Fludarabine
  • DRUG Bendamustine
  • PROCEDURE Allogeneic Hematopoietic Stem Cell Transplantation
  • BIOLOGICAL Filgrastim-sndz

Study Locations (1)

Texas

  • M D Anderson Cancer Center - Houston

Trial Details

FieldValue
Enrollment Target 25 participants
Start Date 2020-03-13
Est. Completion 2027-07-31
Phase Phase 1

Sponsor

M.D. Anderson Cancer Center

2,692 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04022239

The ClinicalTrials.gov registry entry for NCT04022239 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,358-participant average among 31 other Hematopoietic and Lymphoid System Neoplasm trials with a reported enrollment target (98% 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 1 condition, with Hematopoietic and Lymphoid System Neoplasm appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.

NCT04022239 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.

Frequently Asked Questions

What is clinical trial NCT04022239 about?

NCT04022239 is a clinical study titled "Bendamustine With or Without Cyclophosphamide in Preventing GVHD in Patients Undergoing Stem Cell Transplant". This phase I/II trial studies the side effects and best dose of bendamustine when given with or without cyclophosphamide in preventing graft versus host disease (GVHD) in patients undergoing stem cell transplant. Drugs used in chemotherapy, such as bendamustine and cyclophosphamide, work in differen...

What is the current status of trial NCT04022239?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2020-03-13. Estimated completion is 2027-07-31.

What conditions does trial NCT04022239 study?

This clinical trial studies the following conditions: Hematopoietic and Lymphoid System Neoplasm.

What interventions are being tested in trial NCT04022239?

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

Who is sponsoring clinical trial NCT04022239?

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

Where is trial NCT04022239 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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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.