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Phase I/II Study of Treg/Tcon Addback to Partially Matched Related Donor Stem Cells With Myeloablative Conditioning and Post-transplant Cyclophosphamide for High Risk Hematologic Malignancies

NCT01818479 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2020-08-11

No results posted yet for this study

Summary

Open label, dose finding trial to assess the efficacy of Treg/Tcon addback to partially matched related donor stem cells. The maximum tolerated dose will be established using 3 subjects per dose level, with an expansion cohort at the maximum tolerated dose.

Conditions

  • High Risk Hematologic Malignancies

Interventions

BIOLOGICAL

stem cell transplant

Open label, dose finding trial with two treatment regimens, Busulfan and Total Body Irradiation (TBI) with four dose escalation cohorts, to assess the efficacy of Treg/Tcon addback to partially matched related donor stem cells.

PROCEDURE

Stem cell transplant

Sponsors & Collaborators

Principal Investigators

  • Michael Boyer, MD · Huntsman Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-12
Primary Completion
2019-04-01
Completion
2019-04-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01818479 on ClinicalTrials.gov