Refractory or Relapsed Chronic Lymphocytic Leukemia (CLL) MedDRA version: 14.1 Level: LLT Classification code 10008976 Term: Chronic lymphocytic leukemia System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Arzerra
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: OFATUMUMAB
CAS Number: 679818-59-8
Concentration unit: mg milligram(s)
Concentration number: 500-
T
Sponsors
G.I.M.E.M.A. GRUPPO ITALIANO MALATTIE EMATOLOGICHE DELL'ADULTO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients with CLL relapsing after an initial response (CR, PR 6 months) following no more than two prior treatment lines; or - Patients with CLL refractory (SD, PD or CR/PR =65 years) yes F.1.3.1 Number of subjects for this age range 16
Exclusion criteria
Exclusion criteria: - Concurrent use of other anti-cancer agents - Use of any other experimental drug or therapy within 28 days of baseline - Positive direct antiglobulin test (DAT) with clinical and laboratory signs of hemolysis and/or autoimmune thrombocytopenia - Known transformation of CLL - Known CNS involvement of CLL - Known positivity for HIV or active HCV and HBV hepatitis. - Active bacterial, viral or fungal infection requiring systemic anti-viral, antibiotic or anti-fungal therapy. - Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form. - Subjects who have current active hepatic or biliary disease (with exception of patients with Gilbert`s syndrome, asymptomatic gallstones or stable chronic liver disease per investigator assessment) - Pregnant or Lactating Females - Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she was to participate in the study or confounds the ability to interpret data from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the trial is to evaluate the Overall Response Rate [ORR, percentage of patients who achieve CR, CRi, MRD negative CR (cytometric and molecular), PR] after BendOfa treatment given in patients with refractory or relapsed CLL.;Secondary Objective: To evaluate: 1) Quality of response: complete remission (CR), CR with incomplete marrow recovery (CRi), MRD negative CR (cytometric, molecular), partial remission (PR). 2) BendOfa therapy in terms of safety. 3) Progression Free Survival (PFS). 4) Time To Progression (TTP). 5) Duration of response. 6) Time To Next Treatment (TTNT). 7) Overall Survival (OS). 8) Response rate, duration of response, OS and TTNT according to the biologic features of CLL. 9) Clinical outcomes of subjects treated with BendOfa on the basis of the pre-treatment Cumulative Illness Rating Scale (CIRS) scores.;Primary end point(s): Overall Response Rate (ORR, percentage of patients who achieve CR, CRi, MRD negative CR [cytometric and molecular], PR).;Timepoint(s) of evaluation of this end point: During and at the end of the treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1.Rate of CR, CRi, MRD negative CR (cytometric and molecular), PR 2.Toxicity according to CTCAE version 4.0 3. TTP, will be calculated from the date of first BendOfa treatment dose - induction phase - until the date of the first documentation of progressive disease using the cumulative incidence method, where death without signs of disease progression will be considered as competing risk. Patients still alive and known to be progression free will be censored at the moment of last follow-up. 4. PFS, will be calculated from the date of first BendOfa treatment dose - induction phase - until the date of the first documentation of progressive disease or until death (whatever the cause), whichever occurs first. Patients still alive and known to be progression free will be censored at the moment of last follow-up. 5. TTNT, will be calculated from the date of last BendOfa treatment dose until date of a new treatment received for CLL, where death occurred before the new treatment will be considered as competing risk. Patients still alive without receiving a new treatment will be censored at the time of the last follow-up. 6. OS, defined as the time interval between the date of first BendOfa treatment dose - induction phase and the date of death for any cause; patients still alive will be censored at the moment of last follow-up. 7. Duration of response, will be defined as the time to achievement ORR to either progression/relapse or death without progression or last follow-up in case of no such failure occurs (censoring). 8. Response rate, duration of response, OS and TTNT according to the following biologic features of CLL: IgVH mutational status, FISH abnormalities (6q-; 11q-; +12; 13q-; 17p-), TP53 mutation, CD38 expression, ZAP70 expression. 9. Assess the relationship between ORR, PFS and CIRS total score at screening.;Timepoint(s) of evaluation of this end point: During and at the end of the treatment | — |
Countries
Italy
Contacts
Public ContactCentro Dati
Fondazione GIMEMA Onlus
Outcome results
None listed