Mantle-cell lymphoma (MCL) MedDRA version: 9.1 Level: LLT Classification code 10061275
Conditions
Interventions
Trade Name: ribomustin
Pharmaceutical Form: Powder for infusion*
INN or Proposed INN: Ribomustin, Treanda
CAS Number: 16506-27-7
Current Sponsor code: SDX-105
Concentration unit: mg milligram(s)
Conce
Sponsors
ISTITUTO NAZIONALE PER LA CURA TUMORI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age ≥ 60 years. ECOG Performance Status 0-1. Life expectancy of at least 6 months. Histological diagnosis of MCL (morphology, CD5+ /CD20+ /CD23-, t(11:14) and/or cyclin D1 overexpression). disease requiring treatment (patients with bone marrow only disease, who are candidates for a watch-and-wait approach, will be sxcluded) Adequate bone marrow, liver and renal function, unless the abnormality is related to the tumor and is unlikely to affect the safety of bendamustine and ofatumumab use. Adequate marrow and organ function will be assessed by the following laboratory requirements to be conducted within 7 days prior to screening:Hemoglobin ≥ 9.0 g/dL; Absolute neutrophil count (ANC) ≥ 1000/?l;Platelet count ≥ 75000/?l; Total bilirubin ≤ 1.5 times the ULN; AST and ALT ≤ 2.5 x ULN; Alkaline phosphatase ≤ 4 x ULN; Serum creatinine ≤ 2.5 x ULN; PT-INR/PTT =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects who have current active hepatic or biliary disease (with exception of patients with Gilbert`s syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment). History of cardiac disease: congestive heart failure > NYHA class 2; active CAD (MI more than 6 mo prior to study entry is allowed); cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted) or uncontrolled hypertension. History of HIV infection or active chronic hepatitis B or C. Active clinically serious infections (> grade 2 NCI-CTC version 3.0). History of organ allograft. Patients with evidence or history of bleeding diathesis. Patients undergoing renal dyalisis. Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study except cervical carcinoma in situ, trated basal cell carcinoma, superficial bladder tumor or any cancer curatively treated > 3 years prior to study entry. Substance abuse, medical psychological or social conditions that may interfere with the patient s participation in the study or evaluation of the study results. Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - rate of complete or major clinical-hematological response after treatment with dexamethazone, ofatumumab and bendamustine - Safety profile of the combination therapy with dexamethazone, ofatumumab and bendamustine - Safety profile of the maintenance therapy with ofatumumab;Secondary Objective: - response duration - Mobilization of CD34+ cells after DOT - In vivo purging of CD34+ cells after DOT;Primary end point(s): - rate of complete or major clinical-hematological response after treatment with dexamethazone, ofatumumab and bendamustine - Safety profile of the combination therapy with dexamethazone, ofatumumab and bendamustine - Safety profile of the maintenance therapy with ofatumumab | — |
Countries
Italy
Outcome results
None listed