Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03320642
Other study ID # INCB 39110-119/GRAVITAS-119
Secondary ID
Status Terminated
Phase Phase 1
First received
Last updated
Start date February 27, 2018
Est. completion date February 17, 2022

Study information

Verified date April 2022
Source Incyte Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to assess the impact and safety of itacitinib in combination with calcineurin inhibitor (CNI)-based interventions for the prophylaxis of graft-versus-host-disease (GVHD).


Recruitment information / eligibility

Status Terminated
Enrollment 84
Est. completion date February 17, 2022
Est. primary completion date February 25, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Subjects with acute leukemia, chronic myelogenous leukemia, or myelodysplasia with no circulating blasts and < 5% blasts in the bone marrow. - Subjects with non-Hodgkin lymphoma, including but not limited to chronic lymphocytic leukemia/small lymphocytic lymphoma, follicular, marginal zone, diffuse large B cell, or mantle cell lymphoma must have chemosensitive disease at time of transplant. Subjects with Hodgkin lymphoma with chemosensitive disease at the 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. Exclusion Criteria: - 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. - History of primary idiopathic myelofibrosis or any severe marrow fibrosis that would prolong neutrophil engraftment to > 28 days after transplant. - Post-transplant maintenance therapy for the hematologic malignancy or plans to initiate maintenance therapy during study treatment.

Study Design


Intervention

Drug:
Itacitinib
Itacitinib administered orally once daily at the protocol-defined dose.
Calcineurin inhibitor
The CNI-based prophylaxis regimen will be identified by the investigator before the subject's enrollment and will consist of the combination of tacrolimus/methotrexate, cyclosporine A/mycophenolate mofetil or tacrolimus plus post-treatment cyclophosphamide. Antithymocyte globulin may be included at the treating investigator's discretion with the tacrolimus/methotrexate or cyclosporine A/mycophenolate mofetil combinations.

Locations

Country Name City State
France Chru de Lille Hopital Claude Huriez Lille
France Centre Hospitalier Universitaire de Nantes (Chu de Nantes) - Hotel-Dieu Nantes
France Chu Vandoeuvre-Les-Nancy, Hopital Brabois Vandoeuvre-les-nancy
Italy Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii (Presidio Papa Giovanni Xxiii) Bergamo
Italy Azienda Ospedaliera San Gerardo Di Monza Monza
Italy Comitato Di Bioetica Della Fondazione Irccs Policlinico San Matteo Pavia
Spain Hospital Puerta de Hierro Majadahonda
Spain Hospital Clinico Universitario de Valencia Valencia
United States Winship Cancer Institute of Emory University Atlanta Georgia
United States Anschutz Cancer Pavilion - University of Colorado Aurora Colorado
United States University of Maryland - Greenebaum Cancer Center Baltimore Maryland
United States The Ohio State University Columbus Ohio
United States John Theurer Cancer Center, Hackensack University Medical Center Hackensack New Jersey
United States Loyola University Medical Center Maywood Illinois
United States Froedtert Hospital and the Medical College of Wisconsin Milwaukee Wisconsin
United States Memorial Sloan Kettering Cancer Center New York New York
United States Washington University School of Medicine Saint Louis Missouri

Sponsors (1)

Lead Sponsor Collaborator
Incyte Corporation

Countries where clinical trial is conducted

United States,  France,  Italy,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of participants with hematologic recovery when itacitinib is added to GVHD prophylaxis treatment 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). Day 28
Secondary GVHD relapse-free survival rate Defined as the proportion of subjects who do not experience Grade III-IV acute GVHD (aGVHD), chronic GVHD (cGVHD) requiring systemic therapy, malignancy relapse or progression, or death due to any cause. Days 100, 180 and 365
Secondary Relapse-free survival Defined as the interval between enrollment and malignancy relapse or progression, or death, whichever occurs first. Up to 1 year
Secondary Transplant-related mortality Defined as the proportion of subjects who die due to causes other than malignancy relapse or progression. Up to 1 year
Secondary Median time to neutrophil and platelet engraftment Defined as the median time to achieve neutrophil and platelet engraftment. Up to Day 28
Secondary Percentage of participants who achieve neutrophil and platelet engraftment Defined as the median time to achieve engraftment and hematologic recovery at prespecified time points. Up to Day 28
Secondary Donor Chimerism Up to Day 28
Secondary Proportion of subjects who are diagnosed with Grade II-IV aGVHD, by each grade and by Grade III/IV Measured to assess the incidence of aGVHD. Days 100 and Days 180
Secondary Proportion of subjects who are diagnosed with cGVHD by grade (mild, moderate, or severe) Measured to assess the incidence of cGVHD. Up to 1 year
Secondary Infection rate Defined as the proportion of subjects who demonstrate an infection and/or cytomegalovirus reactivation. Up to 1 year
Secondary Overall survival Defined as the interval between enrollment and death due to any cause. Up to 1 year
Secondary Participants with Grade 3-5 treatment-emergent adverse events (TEAEs) TEAE is defined as either an adverse event (AE) reported for the first time or worsening of a pre-existing condition after the first dose of study treatment. Up to approximately 200 days
See also
  Status Clinical Trial Phase
Recruiting NCT05433090 - An Inpatient Advance Care Planning Intervention for Older Patients With Hematologic Malignancies N/A
Completed NCT00061620 - Phase I Study of Continuous Infusion Schedule of FMdC in Hematologic Malignancies Phase 1
Enrolling by invitation NCT02473757 - Gene Therapy Follow-up Protocol for People Previously Enrolled in CAR-T Cell Studies
Not yet recruiting NCT06296368 - DISCOVERY: Evaluating a Decision Support Tool for Adults Seen in Hematology/Oncology Clinics N/A
Recruiting NCT02032446 - Umbilical Cord Derived Mesenchymal Stromal Cells For The Treatment of Severe Steroid-resistant Graft Versus Host Disease Phase 1/Phase 2
Recruiting NCT01203722 - Reduced Intensity, Partially HLA Mismatched BMT to Treat Hematologic Malignancies Phase 1/Phase 2
Recruiting NCT02884375 - Elderly CAncer Patient N/A
Completed NCT00780052 - Infusional C-myb ASODN in Advanced Hematologic Malignancies Phase 1
Recruiting NCT04098393 - Giving Chemotherapy for a Shortened Amount of Time Before a Stem Cell Transplantation Phase 1
Recruiting NCT06028828 - Risk-ADAPTed Conditioning Regimen for Allogeneic Hematopoietic Stem Cell Transplantation Phase 2
Completed NCT04538599 - RD13-01 for Patients With r/r CD7+ T/NK Cell Hematologic Malignancies Phase 1
Completed NCT03609827 - Study of Melphalan Drug Exposure in Pediatric Hematopoietic Stem Cell Transplant Patients
Completed NCT01380756 - Study Evaluating Orally Administered AMG 900 in Adult Subjects With Acute Myeloid Leukemia Phase 1
Recruiting NCT05849207 - Post-Transplant Cyclophosphamide in Patients Aged >/= 70 Years Undergoing Haploidentical Transplant Phase 1
Not yet recruiting NCT05028478 - A Study of CN202 in Adult Subjects With Locally Advanced or Metastatic Solid Tumors or Hematologic Malignancies Phase 1/Phase 2
Active, not recruiting NCT02494258 - A Study to Evaluate Long-term Safety of CC-486 (Oral Azacitidine) in Subjects With Hematological Disorders Phase 2
Completed NCT03212560 - Exercise Capacity and Physical Activity Levels in Newly Diagnosed Hematologic Malignant Patients
Active, not recruiting NCT02600208 - Peripheral Blood Stem Cell Transplantation for Hematologic Malignancies With Alpha Beta TCell and B Cell Depletion Using the CliniMACS Device Phase 2/Phase 3
Completed NCT02145403 - Phase 1/2 Study of Carfilzomib for the Prevention of Relapse and GVHD in Allo-HCT for Hematologic Malignancies Phase 1/Phase 2
Completed NCT01949545 - Study of the Pharmacokinetics and Safety of Carfilzomib in Patients With Advanced Malignancies and Hepatic Impairment Phase 1