Mantle Cell Lymphoma Clinical Trial
— CITADEL-310Official title:
A Phase 3, Randomized, Double-Blind Study Comparing Parsaclisib, a PI3Kδ Inhibitor, in Combination With Bendamustine and Rituximab (BR), With Placebo and BR for the Treatment of Newly Diagnosed Mantle Cell Lymphoma
Verified date | April 2022 |
Source | Incyte Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a Phase 3, double-blind, randomized, placebo-controlled, multicenter study of parsaclisib plus BR versus placebo plus BR as first-line treatment of participants with newly diagnosed MCL.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | July 7, 2034 |
Est. primary completion date | August 15, 2030 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Male and female participants aged 18 years or older. (Japan aged 20 years or older.) - Have received no previous systemic anti-lymphoma therapies. - Pathologically confirmed MCL by local laboratory. - Histologically confirmed CD20 expression (by flow cytometry or immunohistochemistry) of the MCL cells as assessed by pathology. - Ineligible for high-dose chemotherapy and autologous stem cell transplantation. - Radiographically (CT, MRI) measurable lymphadenopathy per the Lugano criteria for response assessment (Cheson et al 2014). - ECOG PS of 0 to 2. - Willingness to avoid pregnancy or fathering children. Exclusion Criteria: - Presence of any lymphoma other than MCL. - Presence of CNS lymphoma (either primary or secondary) or leptomeningeal disease. - Requires treatment with potent inducers and inhibitors of CYP3A4 - Inadequate organ functions including hematopoiesis, liver, and kidney significant concurrent, uncontrolled medical condition, including, but not limited to, renal, hepatic, hematological, GI, endocrine, pulmonary, neurological, cerebral, or psychiatric disease. - History of other malignancy within 2 years of study entry. - Known HIV infection, HBV or HCV. - HBV or HCV infection: Participants positive for HBsAg or anti-HBc will be eligible if they are negative for HBV-DNA; these participants must receive prophylactic antiviral therapy. Participant's positive for HCV antibody will be eligible if they are negative for HCV-RNA. - Clinically significant cardiac disease, congestive heart failure, including unstable angina, acute myocardial infarction, or cardiac conduction issues, within 6 months of randomization. - Abnormal ECG findings that are clinically meaningful per investigator's assessment. - Women who are pregnant or breastfeeding - Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study treatment and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Incyte Corporation |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression Free Survival | Defined as the time from the date of randomization until the date of first-documented disease progression, as determined by an Independent Review Committee (IRC) based on the Lugano criteria, or death from any cause, whichever happens first. | 7 years | |
Secondary | Overall Survival | Defined as the time from the date of randomization until death from any cause. | 10 years | |
Secondary | Objective Response Rate | Defined as the proportion of participants with a Complete Response (CR) or Partial Response (PR) as determined by an IRC- provided radiographic disease assessment of response according to response criteria for lymphomas. | 7 Years | |
Secondary | Complete Response Rate | Defined as the proportion of participants with a CR as determined by an IRC- provided radiographic disease assessment of response according to response criteria for lymphomas. | 7 Years | |
Secondary | Duration of Response | Defined as the time from first-documented evidence of CR or PR until first documented disease progression or death from any cause, whichever happens first, among participants who achieve an objective response, as determined by radiographic disease assessment provided by an IRC. | 7 Years | |
Secondary | Duration Of Complete Response | Defined as the time from the first evidence of CR to the date of first documented disease progression or death from any cause, whichever happens first, among participants who achieve a CR, as determined by radiographic disease assessment provided by an IRC. | 7 Years | |
Secondary | Disease Control Rate | Defined as the proportion of participants who achieved a response of CR, PR, or Stable Disease (SD) assessed by an IRC. | 7 Years | |
Secondary | Event Free Survival | Defined as the time from date of randomization to date of first documented progression, as determined by radiographic disease assessment provided by an IRC, administration of a new anti lymphoma treatment, or death from any cause, whichever happens first. | 7 Years | |
Secondary | Time To Next anti-Lymphoma Treatment | Defined as the time from date of randomization to date of first documented administration of a new anti-lymphoma treatment. | 7 Years | |
Secondary | Progression-Free Survival on next anti-lymphoma treatment | Defined as the time from the date of randomization to the date of first documented disease progression as reported by investigator after next anti-lymphoma treatment or death from any cause, or start of a third anti-lymphoma treatment since randomization, whichever happens first. | 7 Years | |
Secondary | Treatment Emergent Adverse Events | Adverse events reported for the first time or worsening of a pre-existing event after the first dose of study drug/treatment. | 7 Years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Enrolling by invitation |
NCT01804686 -
A Long-term Extension Study of PCI-32765 (Ibrutinib)
|
Phase 3 | |
Recruiting |
NCT05976763 -
Testing Continuous Versus Intermittent Treatment With the Study Drug Zanubrutinib for Older Patients With Previously Untreated Mantle Cell Lymphoma
|
Phase 3 | |
Recruiting |
NCT03676504 -
Treatment of Patients With Relapsed or Refractory CD19+ Lymphoid Disease With T Cells Expressing a Third-generation CAR
|
Phase 1/Phase 2 | |
Recruiting |
NCT05365659 -
IKS03 in Patients With Advanced B Cell Non-Hodgkin Lymphomas
|
Phase 1 | |
Recruiting |
NCT05471843 -
Study of BGB-11417 Monotherapy in Participants With Relapsed or Refractory Mantle Cell Lymphoma
|
Phase 1/Phase 2 | |
Recruiting |
NCT05076097 -
A Study of OLR in First-line Treatment of Mantle Cell Lymphoma
|
Phase 2 | |
Active, not recruiting |
NCT04082936 -
A Study of Imvotamab Monotherapy and in Combination in Subjects With Relapsed/Refractory Non-Hodgkin Lymphoma
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT03891355 -
Carfilzomib + Lenalidomide and Dexamethasone for BTK Inhibitors Relapsed-refractory or Intolerant MCL
|
Phase 2 | |
Recruiting |
NCT04883437 -
Acalabrutinib and Obinutuzumab for the Treatment of Previously Untreated Follicular Lymphoma or Other Indolent Non-Hodgkin Lymphomas
|
Phase 2 | |
Terminated |
NCT03585725 -
A Pilot Investigator-Initiated Study of Ribavirin in Indolent Follicular Lymphoma and Mantle Cell Lymphoma
|
Early Phase 1 | |
Recruiting |
NCT02892695 -
PCAR-119 Bridge Immunotherapy Prior to Stem Cell Transplant in Treating Patients With CD19 Positive Leukemia and Lymphoma
|
Phase 1/Phase 2 | |
Terminated |
NCT02877082 -
Tacrolimus, Bortezomib, & Thymoglobulin in Preventing Low Toxicity GVHD in Donor Blood Stem Cell Transplant Patients
|
Phase 2 | |
Completed |
NCT01665768 -
Maintenance Rituximab With mTor Inhibition After High-dose Consolidative Therapy in Lymphoma
|
Phase 2 | |
Completed |
NCT01437709 -
Ofatumumab With or Without Bendamustine for Patients With Mantle Cell Lymphoma Ineligible for Autologous Stem Cell Transplant
|
Phase 2 | |
Completed |
NCT00963534 -
Lenalidomide, Bendamustine and Rituximab as First-line Therapy for Patients Over 65 Years With Mantle Cell Lymphoma.
|
Phase 1/Phase 2 | |
Completed |
NCT00921414 -
Mantel Cell Lymphoma Efficacy of Rituximab Maintenance
|
Phase 3 | |
Withdrawn |
NCT00541424 -
Combined CT Colonography and PET Imaging in Mantle Cell Lymphoma
|
N/A | |
Completed |
NCT01456351 -
Bendamustine Plus Rituximab Versus Fludarabine Plus Rituximab
|
Phase 3 | |
Completed |
NCT01851551 -
Phase 1/2 Study of VSLI Plus Rituximab in Patients With Relapsed and/or Refractory NHL
|
Phase 1/Phase 2 | |
Completed |
NCT03295240 -
The Study of Bendamustine, Rituximab, Ibrutinib, and Venetoclax in Relapsed, Refractory Mantle Cell Lymphoma
|
Early Phase 1 |