Trial · NCT03862833
Zoledronic Acid in Combination With Interleukin-2 to Expand Vγ9Vδ2 T Cells After T-replete Haplo-identical Allotransplant
NCT03862833, Phase 1, Completed, Nantes University Hospital
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Zoledronic Acid in Combination With Interleukin-2 to Expand Vγ9Vδ2 T Cells After T-replete Haplo-identical Allotransplant. Trials, record NCT03862833. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03862833
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Zoledronic Acid in Combination With Interleukin-2 to Expand Vγ9Vδ2 T Cells After T-replete Haplo-identical Allotransplant
- NCT number
- NCT03862833
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 30 participants, actual
- Lead sponsor
- Nantes University Hospital
- Conditions
- Hematopoietic Stem Cell Transplantation
- Interventions
- IL2, Zoledronic Acid
- First posted
- 2019-03-05
- Last updated
- 2026-09-14
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 38165016 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03862833
GET https://conductscience.org/api/trials/v1/NCT03862833/registered