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GRAVITAS-119: A Single-Arm, Open-Label, Phase 1 Study of Itacitinib in Combination With Calcineurin Inhibitor-Based Interventions for the Prophylaxis of Graft-Versus Host Disease - INCB39110-119

Studio Clinico

Patologia: Linfomi, Altre neoplasie

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: No

Fase di studio: I,

Richiesta mandatoria di tessuto: No

Linee di trattamento: Non applicabile

Criteri di inclusione: 

- Subjects with acute leukemia, chronic myelogenous leukemia, or myelodysplasia must have no circulating blasts and < 5% blasts of the bone marrow.
- Subjects with chronic lymphocytic leukemia/small lymphocytic lymphoma, follicular, marginal zone, diffuse large B cell, Hodgkin's lymphoma, or mantle cell lymphoma must have chemosensitive disease at time of transplant.
- Must be candidates for reduced-intensity conditioning regimens.
- Must be candidates for peripheral blood stem cell transplants.
- Karnofsky Performance Status score ≥ 70% or Eastern Cooperative Oncology Group Performance Status score of 0 to 2.
- Serum creatinine ≤ 2.0 mg/dL or creatinine clearance ≥ 40 mL/min measured or calculated by Cockcroft-Gault equation.
- Be willing to avoid pregnancy or fathering children

Criteri di esclusione: 

- Has previously received an allogenic hematopoietic stem cell transplant.
- Presence of an active uncontrolled infection.
- Known HIV infection.
- Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection that requires treatment or at risk for HBV reactivation.
- Prior malignancies.
- Severe organ dysfunction.
- Prior treatment with a JAK inhibitor or with an investigational agent, device, or procedure within 21 days of enrollment.
- Currently breastfeeding.
- Known allergies, hypersensitivity, or intolerance to any of the study medications.
- Receipt of live (including attenuated) vaccines during the study, or anticipation of need for such a vaccine during the study.

Trattamento sperimentale: 

Itacitinib+Calcineurin inhibitor-Based Interventions
 

Trattamento di controllo: 

NA

Obiettivi primari dello studio: 

Proportion of participants with hematologic recovery when itacitinib is added to GVHD prophylaxis treatment [Time Frame: Day 28]
Hematologic recovery defined as demonstrating both neutrophil recovery (ANC ≥ 500/mm^3 for 3 consecutive measurements) and platelet recovery (platelet count ≥ 20,000/mm^3 with no requirement for platelet transfusion in the preceding 3 days).

Centri partecipanti

Nord Italia

Ospedale Papa Giovanni XXIII Bergamo
Piazza OMS 1 - 24127 Bergamo - BG

Riferimento: Prof. Alessandro Rambaldi
Telefono: 0352673684
Email: arambaldi@asst-pg23.it

 

A.O. San Gerardo
Via Pergolesi 33 - 20900 Monza - MB

Riferimento: Prof. Carlo Gambacorti Passerini
Email: info_ematologia@asst-monza.it

 

IRCCS Policlinico San Matteo
Viale Golgi 19 - 27100 Pavia - PV

Riferimento: Prof. Paolo Bernasconi

Informazioni Generali

Protocollo

Numero di iscrizione a registro: NCT03320642

Data di inserimento: 20.06.2018

Data di aggiornamento: 20.03.2019

Promotore

CRO

NA

Principal Investigator ITALIA

ASST Papa Giovanni XXIII, Bergamo

Riferimento: Prof. Alessandro Rambaldi

Telefono: 0352673684

Email: arambaldi@asst-pg23.it

Localita: Bergamo

 

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