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Ixazomib in the Prophylaxis of Chronic Graft-versus-host Disease.

StatusUnknown
PhasePhase 1/2
Started2017-05-16
View on ClinicalTrials.gov ↗

Amendment history

2026-09-06
Trial status changed: Active, Not Recruiting → Unknown
2024-08-28
Study Status, Sponsor/Collaborators v8
Trial statusActive, Not Recruiting→Unknown
Collaborators+41 characters
Spanish Clinical Research Network - SCReN
2024-03-18
Study Status v7
Primary completion dateestimated 2023-08-04→confirmed 2024-01-11
Completion date2023-12-31→2024-12-31
2023-05-02
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v6
Trial statusRecruiting→Active, Not Recruiting
Study sitesdetails revised at 8 of 8 sites
2022-05-20
Study Status, Arms and Interventions, Outcome Measures, IPDSharing v5
Primary completion date2022-04-16→2023-08-04
Completion date2022-10-31→2023-12-31
Secondary endpoints7 to 8 entries
Event immune recovery for the phase I study Overall disease free survival for phase II study. Serious adverse event for phase II study. Risk of moderate or severe GVHD for phase II study.
Primary endpoints3 to 2 entries
EvaluateMaximun the immune recovery for the phase I study To identify the optimaltolerated dose and evaluate ixazomib tolerance used after transplantation for the phase I study
Show 4 earlier versions
2021-01-08
Study Status v4
Re-verified, no change to tracked fields
2019-11-04
Study Identification, Study Status, Study Description, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v3
Primary completion date2021-05-16→2022-04-16
Completion date2022-11-16→2022-10-31
Study sites7→8
InterventionsIxazomib (Drug), Sirolimus (Drug), Tacrolimus (Drug)→Any prophylaxis for GVHD (Drug), Ixazomib (Drug), Sirolimus (Drug), Tacrolimus (Drug)
Eligibility criteria+93 characters
Inclusion Criteria: Male or female patients 18 years or older. Patients havingon the day +100 +/- 20 days who have received an allogeneic transplant with myeloablative or reduced intensity conditioning peripheral blood allogeneic stem cell transplantation. Patients undergoingwho have received a hematopoietic stembone cellmarrow transplant hematopoietic progenitors of peripheral blood from ahisto matched/ or a single mismatched related or unrelatedcompatible donor as definition accepted by protocol. Patients receiving Graft-versus-host Diseaseany prophylaxis withfor sirolimusGVHD, andexcept tac [...] [...]
Secondary endpoints6 to 7 entries
Event free survival for phase II study. Event immune recovery for phase II study. Exposure to immunosuppressive treatment for phase II study. Overall disease free survival for phase II study. Serious adverse event for phase II study. Risk of moderate or severe GVHD for phase II study. Differences among patients receiving a reduced-intensity and myeloablative conditioning regimen for phase II study.
Primary endpoints3 entries, revised
Evaluate the immune recovery for the phase I study
Study description+183 characters
The study design is based on a phase I / II trial in seveneight Spanish hospitals. In the phase I, a number of 3 to 12 pati [...] ndation added in order to evaluate the efficacy of ixazomib. This patients who will receive any prophylaxis for GVHD, except those patients who received antithymocyte globulin , cyclophosphamide or any T depletion protocol in vitro or in vivo.
Study title-45 characters
Ixazomib in Combination With Sirolimus and Tacrolimus in the Prophylaxis of Chronic Graft-versus-host Disease.
2019-07-25
Study Status, Study Description, Study Design, Outcome Measures, Eligibility, Contacts/Locations v2
Primary completion date2020-06-27→2021-05-16
Completion date2023-05-27→2022-11-16
Enrollment target154→142
Eligibility criteria+126 characters
[...] reatment of active proven, probable or possible infections. Ability to understand the nature of this study and give written informed consent. Exclusion Criteria: Female patients who are lactating or hav [...] they have undergone complete resection. Patient has Grade 1 with pain or ≥ grade 2 with or without pain peripheral neuropathy. Participation in other clinical trial [...]
Secondary endpoints4 to 6 entries
Serious adverse event Risk of moderate or severe GVHD
Primary endpoints2 to 3 entries
Evaluate the immune recovery
Study descriptionrevised
The study design is based on a phase I / II trial in seven Spanish hospitals. In the phase I, a number of 3 to 2412 patients will be included to evaluate the optimal dose of i [...]
Study sitescontacts updated at 1 of 7 sites
2019-05-03
Study Status v1
Re-verified, no change to tracked fields
2017-07-18
Original filing
Allogeneic hematopoietic stem cell transplantation (HTC) is the only curative option for many patients with hematologic malignancies but \>50% of this patients will develop extensive chronic graft-versus-host disease (cGVHD), which remains the most important complication after HTC. Classically, the most effective strategies to prevent GVHD have not improved survival; therefore, the new strategies are being sought. This study is designed in two phases: the main objective for phase I study is the more suitable dose for ixazomib search. Phase II study is designed to evaluate the efficacy of ixazomib at the doses stablished in phase I.
Trial Details
NCT Number NCT03225417
Lead Sponsor Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Collaborators: Spanish Clinical Research Network - SCReN
Conditions Hematopoietic Stem Cell Transplantation, Multiple Myeloma
Enrollment 142 participants
Start Date 2017-05-16
Primary Completion 2024-01-11 (estimated)
Study Completion 2024-12-31 (estimated)
Updated on ClinicalTrials.gov 2024-08-30