Advanced non Hodgkin's or Hodgkin's lymphoma
Conditions
Interventions
Product Name: HCD122
Product Code: HCD122
Pharmaceutical Form: Solution for infusion
Current Sponsor code: HCD122
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentrat
Sponsors
Novartis Pharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Patients must have confirmed diagnosis, according to the Revised European American Lymphoma/World Health Organization [REAL/WHO] classification, of the following B-cell lymphomas: 1.Follicular lymphoma (FL) 2.Marginal zone lymphoma (MZL)/mucosa-associated lymphoid tissue (MALT) 3.Diffuse large B-cell lymphoma (DLBCL) 4.Mantle cell lymphoma (MCL), OR 5.Hodgkin lymphoma (HL) •Patients must have progressed after at least 2 prior therapies (autologous stem cell transplantation is considered as 1 therapy): 1.Patient must receive at least one prior therapy with a rituximab containing regimen if it is indicated as the standard of care. 2.If patient received autologous stem cell transplantation, patient must have received at least 1 prior systemic therapy 3.If patient did not receive autologous stem cell transplantation, patient must have received at least 2 prior systemic therapies •Patients who received autologous stem cell transplantation: 1.Must be at least 12 weeks post-transplant prior to study drug, AND 2.Must have recovered fully from the side effects of such treatment prior to beginning study treatment. •Patients who have NOT received autologous stem cell transplantation: 1.Must be ineligible for the autologous stem cell transplantation, OR 2.If eligible, patients chose not to receive stem cell transplant •Patients must have discontinued any previous anticancer and investigational therapy including radiation therapy for at least 21 days prior to study drug, and must have recovered fully from the side effects of such treatment prior to beginning study drug. •Patients must have discontinued any previous monoclonal antibody (except rituximab) or radioimmunotherapy administration for at least 60 days prior to study drug, and are confirmed either have no response to that therapy or have disease progression after the treatment. Patients must have recovered fully from the side effects of that treatment prior to beginning study treatment. For patients who received rituximab containing regimen, rituximab should be discontinued for at least 28 days prior to study drug, are confirmed to either have no response or have disease progression after rituximab treatment, and must have recovered fully from the side effects of such treatment prior to beginning study drug. •Patients must not have undergone major surgery within 30 days prior to study drug, and must have recovered fully from the side effects of any major or minor surgical procedures prior to study treatment. •Patients must be ? 18 years Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: •Patients who have been treated with any anti-CD40 antibody •Patients who have received prior allogeneic stem cell transplant •Patients who have had a prior anaphylactic or other severe infusion reaction such that the patient is unable to tolerate human immunoglobulin or monoclonal antibody administration •Patients who are taking systemic corticosteroids, except for a dose up to 100 mg of hydrocortisone or equivalent as premedication administered prior to certain medications or blood products •Patients who have current drug or alcohol abuse •Patients who have history or clinical evidence of central nervous system, meningeal, or epidural disease including brain metastasis •Impaired cardiac function or clinically significant cardiac disease, including any one of the following: 1.New York Heart Association Class III or IV cardiac disease, including preexisting clinically significant arrhythmia, congestive heart failure, or cardiomyopathy 2.Angina pectoris = 3 months prior to starting study drug 3.Acute MI = 3 months prior to starting study drug 4.Other clinically significant heart disease (e.g., uncontrolled hypertension, history of labile hypertension, or history of poor compliance with an antihypertensive regimen) •Patients who have history of pancreatic disease (e.g., acute or chronic pancreatitis, etc.) or any surgery of the pancreas •Patients who have gallbladder stone, cystic fibrosis, or any other risk factors that may increase the risk of pancreatitis •Patients who have history of active infection (viral, bacterial, or fungal) requiring systemic therapy within 4 weeks prior to enrollment. Prophylactic antibiotics and anti-viral therapies are permitted
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Dose escalation phase Primary objective: 1.To determine the maximum tolerated dose (MTD) or the recommended Phase II dose of HCD122 when administered as a single agent intravenously (IV) once weekly for 4 weeks to adult patients with advanced non-Hodgkin’s or Hodgkin’s lymphoma who have progressed after at least two prior therapies Dose expansion phase Primary objective: 1.To assess clinical response at the MTD or the recommended phase II dose in adult patients with advanced non-Hodgkin’s or Hodgkin’s lymphoma who have progressed after at least two prior therapies ;Primary end point(s): Dose escalation phase: Incidence rate of DLT Dose expansion phase: Response rate according to the 2007 Cheson criteria;Secondary Objective: Dose escalation phase: Main Secondary objective: 1.To characterize safety and tolerability of single agent HCD122, including acute and chronic toxicities 2.To characterize the pharmacokinetic (PK) profile after single and repeated doses of single agent HCD122 on a once weekly dosing schedule for 4 weeks 3.To assess the immunogenicity of HCD122 4.To characterize the CD40 occupancy profile of HCD122 on peripheral CD19(+) B cells after single and repeated doses Dose expansion phase: Main Secondary objectives: 1.To characterize safety and tolerability of single agent HCD122, including acute and chronic toxicities 2.To characterize the pharmacokinetic (PK) profile after single and repeated doses of single agent HCD122 on a once weekly dosing schedule for 4 weeks for the first 40 patients in dose expansion phase 3.To assess the immunogenicity of HCD122 4.To characterize the CD40 occupancy profile of HCD122 on peripheral CD19(+) B cells after single and repeated doses | — |
Countries
Belgium, France, Germany, United Kingdom
Outcome results
None listed