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Treatment of Chronic Graft Versus Host Disease With Arsenic Trioxide

NCT02966301 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2022-05-09

Study results available
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Summary

This study aims to evaluate the early chronic GvHD events (first line therapy), if the addition of arsenic trioxide to standard therapy with corticosteroids, with or without cyclosporine, will be effective in controlling chronic GvHD and to reduce the duration of corticosteroid therapy

Conditions

  • Chronic Graft-Versus-Host Disease
  • Immune System Diseases

Interventions

DRUG

Arsenic Trioxide Injectable Solution

Each patient will receive eleven perfusions of arsenic trioxide (0,15 mg/kg/Day - IV administration) over a 4 weeks period (one cycle). Patients in partial response after the 1st cycle of ATO will be eligible to receive a second cycle of ATO as consolidation therapy. A delay of 8 weeks (from the first infusion of ATO) will be observed between the two cycles of ATO therapy. The study duration will be 2 years (12 months recruitment + 12 months follow-up).

Sponsors & Collaborators

  • Medsenic

    lead INDUSTRY

Principal Investigators

  • Mohamad Mohty, Pr · Hôpital Saint-Antoine, AP-HP - Paris

  • Anne Huyhn, Dr · Institut Universitaire du Cancer - Oncopole - Toulouse

  • Sylvain Chantepie, Dr · Institut d'Hématologie de Basse Normandie - CHU de Caen

  • Patrice Chevallier, Dr · Hôtel Dieu - CHU Nantes

  • Didier Blaise, Pr · Institut Paoli Calmettes - Centre de Recherche en Cancérologie de Marseille

  • Patrice Ceballos, Dr · Hôpital St Eloi - Montpellier

  • Patrice Turlure, Dr · University Hospital, Limoges

  • Edouard Forcade, Dr · University Hospital, Bordeaux

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-31
Primary Completion
2020-06-30
Completion
2020-06-30

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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 NCT02966301 on ClinicalTrials.gov