patients with previously untreated CLL MedDRA version: 9.1 Level: SOC Classification code 10005329
Conditions
Interventions
Trade Name: ARZERRA
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: OFATUMUMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration
Sponsors
AZIENDA OSPEDALIERA OSPEDALE NIGUARDA CA` GRANDA (A.O. DI RILIEVO NAZIONALE)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Diagnosis of B-CLL defined by: Circulating lymphocytes of more than or equal to 5_109/L B lymphocytes (5000/_L) in the peripheral blood for the duration of at least 3 months. Flow cytometry confirmation of immunophenotype: CD5, CD19, CD20, CD23, CD79b, and surface Ig Active disease and indication for treatment based on modified NCI-WG guidelines [Hallek et al. 2008] defined by presenting at least any one of the following conditions: Evidence of progressive marrow failure as manifested by development of, or worsening of anemia and/or thrombocytopenia Massive (i.e. > 6 cm below the left costal margin) or progressive or symptomatic splenomegaly Massive nodes (i.e. > 10 cm in longest diameter) or progressive or symptomatic lymphadenopathy Progressive lymphocytosis with an increase of > 50% over a two month period or an lymphocyte doubling time 38.0 ?C for N 2 weeks without evidence of infection c) Night sweats for more than 1 month without evidence of infection Not been previously treated for B-CLL (prior autoimmune hemolytic anemia treatment permitted) ECOG Performance Status of 0-2 Age N 65 years Signed written informed consent prior to performing any studyspecific procedures Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no 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: Prior therapy for B-CLL with any agent except corticosteroids used to treat autoimmune hemolytic anemia • Active autoimmune hemolytic anemia (AIHA) requiring corticosteroid therapy > 100 mg equivalent to hydrocortisone, or chemotherapy PCO Protocol Final Version, 17 August 2010 8 of 65 : • Known Richter transformation • Known CNS involvement of B-CLL • Any radiation therapy R 4 weeks prior to registration; • Any major surgery R 4 weeks prior to registration; • Chronic or current infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment such as, but not limited to, chronic renal infection, chronic chest infection with bronchiectasis, tuberculosis and active Hepatitis C • Past or current malignancy with the exception of basal cell carcinoma of the skin or in situ carcinoma of the cervix or the breast unless the tumor was successfully treated with curative intend at least 2 years prior to trial entry. • Clinically significant cardiac disease including unstable angina, acute myocardial infarction within 6 months prior to Visit 1, congestive heart failure, and arrhythmia requiring therapy, with the exception of extra systoles or minor conduction abnormalities • History of significant cerebrovascular disease • Glucocorticoid unless given in doses R 100 mg/day hydrocortisone (or equivalent dose of other glucocorticoid) if for exacerbations other than B-CLL (e.g. asthma) • Known HIV positive • Positive serology for Hepatitis B (HB), defined as a positive test for HBsAg. In addition if negative for HBsAg but HBcAb positive and HBsAb negative a HB DNA test will be performed and if positive the subject will be excluded. Note: if HBcAb positive and HBsAb positive, which is indicative of a past infection, the subject can be included. • Screening laboratory values: - Creatinine Clearance 2.0 times upper normal limit (unless due to liver involvement of B-CLL) - ALT > 3.0 times upper normal limit (unless due to liver involvement of B-CLL) • Treatment with any non-marketed drug substance or experimental therapy within 4 weeks prior to Visit 1 or currently participating in any other interventional clinical study • Known or suspected inability to comply with a study protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: • To monitor and assess toxicity of pentostatin, cyclophosphamide, and ofatumumab in patients with previously untreated CLL. • To determine the progression-free survival in CLL patients treated with pentostatin, cyclophosphamide, and ofatumumab. • To assess the complete and overall response as well as progression free survival of CLL patients treated with pentostatin, cyclophosphamide, and ofatumumab • To determine if molecular prognostic parameters (ZAP-70, CD38, cytogenetic abnormalities identified by FISH, IgVH mutation status, etc) relate to response to PCO therapy.;Main Objective: To assess the rate of complete and overall response using pentostatin, cyclophosphamide, and ofatumumab in patients with previously untreated CLL requiring therapy and to determine the proportion of patients who achieve a minimal residual disease (MRD) negative state as assessed by flow cytometry.;Primary end point(s): To assess the rate of complete and overall response using pentostatin, cyclophosphamide, and ofatumumab in patients with previously untreated CLL requiring therapy | — |
Countries
Italy
Outcome results
None listed