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NCT02996773 · ClinicalTrials.gov registry record · Phase 1

Haploidentical BMT With Post-Transplant Cyclophosphamide and Bendamustine

A Phase 1 study, sponsored by University of Arizona.

Completed
Registry status
Phase 1
Development phase
50
Enrollment target

NCT02996773 is a Phase 1 study that has completed, run by University of Arizona. The registered enrollment target is 50 participants.

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The verdict

NCT02996773, a Phase 1 study, has completed, sponsored by University of Arizona.

COMPLETED
Registry status
Phase 1
Development phase
50 participants
Enrollment target

Study Summary

The purpose of this study is to evaluate the safety of progressively substituting day +3 and +4 post-transplant cyclophosphamide (PT-CY) with post-transplant bendamustine (PT-BEN) in myeloablative (MAC) haploidentical hematopoietic cell transplantation (HHCT) for patients with hematological malignancies. The goal of the Phase 1 component of the study is to evaluate the safety of progressively substituting post-transplant cyclophosphamide (PT-CY) given on Days +3 and +4 with bendamustine (PT-BEN). The Phase I component of the study has been completed. The Phase Ib component of the study will continue to evaluate the safety and efficacy of subjects who receive PT-BEN on Days +3 and +4 at the maximum tolerated dose determined by Phase I. The Phase Ib component of the study has been completed. Approximately, 18-36 subjects will be treated as part of Phase I and 15 as part of Phase Ib. Approximately 18 subjects will be used as controls, subjects that receive no PET-BEN, for direct comparison. Total, approximately 38-56 treatment and control patients and 38-56 donor subjects will be enrolled.

Interventions

  • DRUG Cyclophosphamide
  • DRUG Bendamustine

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2016-11-29
Est. Completion 2025-08-01
Phase Phase 1

Sponsor

University of Arizona

349 total trials

What the Registry Record Tells You About NCT02996773

The ClinicalTrials.gov registry entry for NCT02996773 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Arizona, which has 349 total studies on file at ClinicalTrials.gov.

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

NCT02996773 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02996773 about?

NCT02996773 is a clinical study titled "Haploidentical BMT With Post-Transplant Cyclophosphamide and Bendamustine". The purpose of this study is to evaluate the safety of progressively substituting day +3 and +4 post-transplant cyclophosphamide (PT-CY) with post-transplant bendamustine (PT-BEN) in myeloablative (MAC) haploidentical hematopoietic cell transplantation (HHCT) for patients with hematological malignan...

What is the current status of trial NCT02996773?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2016-11-29. Estimated completion is 2025-08-01.

What interventions are being tested in trial NCT02996773?

The interventions under investigation include: Cyclophosphamide (DRUG), Bendamustine (DRUG).

Who is sponsoring clinical trial NCT02996773?

This trial is sponsored by University of Arizona, which has 349 total clinical trials registered on ClinicalTrials.gov.

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.