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Irradiation-based Myeloablative Conditioning Followed by Treg/Tcon Immunotherapy in HSCT

NCT03977103 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2020-01-13

No results posted yet for this study

Summary

To evaluate if hyper-fractionated TBI or TMLI followed by Treg/Tcon adoptive immunotherapy improve cGvHD/disease free survival after allogeneic HSCT in patients affected by high-risk acute leukemias or other hematologic malignancy where HSCT is indicated.

Conditions

Interventions

BIOLOGICAL

High dose irradiation conditioning + Treg/Tcon

High dose irradiation based conditioning regimens followed by infusion of donor regulatory and conventional T cells and purified CD34+ hematopoietic stem cell transplantation

Sponsors & Collaborators

  • University Of Perugia

    lead OTHER

Principal Investigators

  • Andrea Velardi, MD, PhD · University Of Perugia

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2023-02-28
Completion
2023-02-28

Countries

  • Italy

Study Locations

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Entities

Diseases

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 NCT03977103 on ClinicalTrials.gov