Treatment of Chronic Graft Versus Host Disease With Arsenic Trioxide (GvHD-ATO)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02966301|
Recruitment Status : Active, not recruiting
First Posted : November 17, 2016
Last Update Posted : August 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Chronic Graft-Versus-Host Disease Immune System Diseases||Drug: Arsenic Trioxide Injectable Solution||Phase 2|
Graft-versus-host disease (GvHD) is the most common long-term complication in patients who underwent allogeneic transplantation.
First-line therapy for chronic GVHD is based on immunosuppressive agents (corticosteroids with or without cyclosporine) achieving satisfactory response in around 30% of patients.
This is a prospective, national, multicenter, non-randomized Phase II study that will include a total number of 24 patients in which, trioxide d'arsenic will be administrated at 0,15mg/kg/day.
Clinical response will be evaluated based on the Working Group Report 2015, published by the National Institute of Health Consensus.
Follow-up visits will be weekly for four weeks (ATO cycle), every two weeks from second to third month of ATO treatment, every month from the fourth to sixth month of ATO treatment and every 3 months, at 9 months and 12 months (final visit).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of First Line Treatment of Chronic Graft Versus Host Disease With Arsenic Trioxide|
|Actual Study Start Date :||December 2016|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||December 2020|
Single arm : Arsenic trioxide Injectable Solution
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).
Other Name: Trisenox / Arscimed
- Number of participants with complete or partial remission of Chronic Graft versus Host Disease after a first line treatment with Arsenic Trioxide [ Time Frame: six months ]Clinical response will be evaluated based on the Working Group Report 2015, published by the National Institute of Health Consensus : Lee SJ et al. Biol Blood Marrow Transplant, 2015 (cGvHD activity assessment Clinician Form A & cGvHD assessment patient self-report Form B)
- Steroid dose reduction (mg/kg/day of prednisone) [ Time Frame: 2 weeks and 3, 6, 9 & 12 months after ATO cycle treatment ]
- Quality of life self-reported by patient using the Lee Symptom Scale (LSS) [ Time Frame: 6 & 14 week, 6, 9 & 12 months ]
- Quality of life self-reported by patient using the Functional Assessment of Chronic Illness : Therapy with Bone Marrow Transplantation subscale (FACT-BMT) [ Time Frame: 6 & 14 week, 6, 9 & 12 months ]
- Time without relapse in case of positive response [ Time Frame: 12 months ]
- Progression-free survival rates [ Time Frame: 12 months ]
- Adverse events [ Time Frame: 12 months ]Follow-up throughout the study
- Blood test of immunoglobulins [ Time Frame: Inclusion, 6 & 14 week, 6, 9 & 12 months ]
- Blood test of arsenic [ Time Frame: D2, D3, D4, D5, D8, D12, D17 and D24, during arsenic trioxide treatment period ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02966301
|CHU de Caen - Institut d'Hématologie de Basse Normandie|
|Caen, France, 14033|
|Institut Paoli Calmettes - Département d'hématologie - Centre de Recherche en Cancérologie de Marseille|
|Marseille, France, 13273|
|CHU Hôtel Dieu - Service Hématologie Clinique|
|Nantes, France, 44093|
|Hôpital Saint Antoine - Hématologie et thérapie cellulaire - AP-HP|
|Paris, France, 75012|
|Institut Universitaire du Cancer - Oncopole - Service d'Hématologie|
|Toulouse, France, 31059|
|Principal Investigator:||Mohamad Mohty, Pr||Hôpital Saint-Antoine, AP-HP - Paris|
|Principal Investigator:||Anne Huyhn, Dr||Institut Universitaire du Cancer - Oncopole - Toulouse|
|Principal Investigator:||Sylvain Chantepie, Dr||Institut d'Hématologie de Basse Normandie - CHU de Caen|
|Principal Investigator:||Patrice Chevallier, Dr||Hôtel Dieu - CHU Nantes|
|Principal Investigator:||Didier Blaise, Pr||Institut Paoli Calmettes - Centre de Recherche en Cancérologie de Marseille|
|Principal Investigator:||Patrice Ceballos, Dr||Hôpital St Eloi - Montpellier|
|Principal Investigator:||Patrice Turlure, Dr||University Hospital, Limoges|
|Principal Investigator:||Edouard Forcade, Dr||University Hospital, Bordeaux|