Trial · NCT03862833
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | determine the maximum tolerated dose (MTD) of early administration of increasing doses of low-dose IL-2 in combination with a fixed dose of Zoledronic acid after haplo-SCT | 28 days after the last injection of IL2 | A dose-limiting toxicity (DLT) will be defined as: * non-hematological toxicity of grade 4, including grade 4 acute GVHD 4. * non-hematological toxicity of grade 3 non-reversible for \> 7 days or reappearance of the same grade 3 after reintroduction of IL2 in case of return to at least one grade 1. * an acute GVHD grade 2-3 for \> 7 days or reappearance of GVHD grade 2-3 acute GVHD after reintroduction of IL2 if at least grade 1 acute GVHD is restored. * a reappearance of a grade 3/4 IL2 allergic reaction after reintroduction of IL2 in the event of a return to at least grade 1 after the occurrence of an allergic reaction of grade 3/4 IL2 when of the administration. * grade 4 pancytopenia with hypocellular bone marrow (no disease detection) for \> 4 weeks after the last administration of IL2. |
| Secondary | Engraftment | day 30, 60,90/100, 6 months and 1 year post-transplant | Concentration of sustained neutrophil recovery (\>500 Giga/L) with full or mixed donor chimerism documentation |
| Secondary | Chimerism (mixed, full or uncompleted) | day 30, 60,90/100, 6 months and 1 year post-transplant | Evaluation of CD3+ T-cell chimerism |
| Secondary | overall survival | last patient follow up : 36 months | the time from day 0 of allo-SCT to death or last follow-up for surviving patients |
| Secondary | disease-free survival | last patient follow up : 36 months | time from day 0 of allo-SCT to time without evidence of relapse or disease progression censored at the date of death or last follow-up. |
| Secondary | relapse rate | last patient follow up : 36 months | any event related to re-occurrence of the disease. |
| Secondary | Non relapse mortality | day 100 post transplant and one year post-transplant | death from any cause without previous relapse or progression |
| Secondary | Incidence of acute GVHD | day 100 post transplant one year post-transplant | Acute GVHD: Harris AC, Young R, Devine S, Hogan WJ, Ayuk F, Bunworasate U, et al. International, Multicenter Standardization of Acute Graft-versus-Host Disease Clinical Data Collection: A Report from the Mount Sinai Acute GVHD International Consortium. Biol Blood Marrow Transplant. 2016 Jan;22(1):4-10. |
| Secondary | Hematologic and immune reconstitutions post-transplant | before the graft and at days 15, 22, 29, 36, 45, 70 | median time for neutrophils recovery (first day with \>0.5 Giga/L for three consecutive days) and platelets recovery \>20, 50 and 100 Giga/L; T CD3, CD4, CD8, NK, B, Tregs, g/d T cells |
| Secondary | Complete remission (CR) rate for lymphoma patients | day 100 post transplant | Cheson criteria |
| Secondary | g/d T cells detection after haplo-SCT | before the graft and at days 15, 22, 29, 36, 45, 70 | Evaluation of T CD3, CD4, CD8, NK, B, Tregs, g/d T cells |
| Secondary | Perturbation of ionic metabolism | before the graft and at days 15, 22, 29, 36, 45, 70 | Evaluation of Vitamin D, Ca, Ph, Na, K, serum creatinine, bilirubin (direct and total), alkaline phosphatase, gammaGT, ALAT, ASAT |
| Secondary | Detection of dysthyroid disease | before the graft and at day 70 | Dosage of T3 T4 TSH |
| Secondary | Incidence of acute and chronic GVHD | one year post-transplant | Chronic GVHD: Filipovich AH, Weisdorf D, Pavletic S, Socie G, Wingard JR, Lee SJ, et al. National Institutes of Health consensus development project on criteria for clinical trials in chronic graft-versus-host disease: I. Diagnosis and staging working group report. Biol Blood Marrow Transplant. 2005 Dec;11(12):945-56. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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