Patients aged >55 years with a diagnosis of CLL according to WHO criteria confirmed by flow cytometry of peripheral blood or bone marrow and a poor-risk disease according to the EBMT CLL Transplant Consensus MedDRA version: 18.0 Level: LLT Classification code 10009310 Term: CLL System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Arzerra
Product Name: Arzerra
Product Code: GSK1841157
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Ofatumumab
CAS Number: 679818-59-8
Current Sponsor co
Sponsors
Technische Universität Dresen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Diagnosis of CLL according to WHO criteria confirmed by flow cytometry of peripheral blood or bone marrow - Age > 55 years - Poor-risk disease according to the EBMT CLL Transplant Consensus: =>Non-response or early relapse (within 12 months) after purine analogue-containing therapy =>Relapse (within 24 months) after purine analogue combination therapy or treatment of similar efficacy (ie, autologous stem cell transplantation) =>p53 deletion/mutation (del 17p-) requiring treatment - Measurable disease in the peripheral blood defined by a minimum clonal lymphocyte count of 0.5 GPT/L at the time of study inclusion - Medically fit patients eligible for allogeneic HCT - Informed consent for related and unrelated donor search and the goal to perform allogeneic HCT -Sexually mature males must agree to use adequate and medically accepted method of contraception throughout the study if their sexual partners are woman of child bearing potential (WOCBP) -WOCBP must be using an adequate and medically accepted method of contraception to avoid pregnancy throughout the study and for at least 3 months after the study. WOCBP includes any female that has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal (defined as amenorrhea >12 consecutive months); or woman on hormone replacement therapy (HRT) with documented serum follicle stimulating hormone (FSH) level >35mlU/mL. -WOCBP must have a negative serum or urin pregnancy test prior to the start of the study. 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 71 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 71
Exclusion criteria
Exclusion criteria: - Richter’s transformation in current relapse or active disease - Prior allogeneic HCT - Treatment with any known non-marketed drug substance or experimental therapy within 5 terminal half lives or 4 weeks prior to enrollment, whichever is longer, or participation in any other interventional clinical study - Non-response to monotherapy with ofatumumab prior to study inclusion - Clinically significant cardiac disease including unstable angina, acute myocardial infarction within six months prior to randomization, congestive heart failure (left ventricular ejection fraction total bilirubin >1.5 times upper normal limit (unless due to AIHA or a known history of Gilbert’s disease) =>ALT or AST >2.5 times upper normal limit =>Gamma glutamyl transpeptidase (GGT) >2.5 times upper normal limit (unless due to disease involvement of the liver) - Other past or current hematologic or solid organ malignancy. Subjects who have been free of malignancy for at least 3 years, or have a history of completely resected non-melanoma skin cancer, or successfully treated in situ carcinoma are eligible. - Male subjects unable or unwilling to use adequate contraception methods from study start to one year after the last dose of protocol therapy. - Pregnant or lactating woman - Significant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease which in the opinion of the investigator may represent a risk for the patient
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To study the safety and efficacy of anti-CD20 blockade with ofatumumab in the context of allogeneic HCT in CLL. ;Secondary Objective: - rate of patients who reach allogeneic HCT - rates of grade III/IV adverse drug reactions - Overall and event and progression-free survival - relapse incidence - non-relapse mortality for the ITT population and transplanted patients - Incidences of acute and chronic GVHD;Primary end point(s): Response rate after induction therapy and rate of MRD-negative patients who did not experience relapse, progression or death within the first 14 months after study enrollment;Timepoint(s) of evaluation of this end point: overall remission rate (CR and PR): immediately after induction therapy MRD-negativity: at 14 months after study inclusion | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - rate of patients who reach allogeneic HCT - rates of grade III/IV adverse drug reactions - Overall, event and progression-free survival - relapse incidence - non-relapse mortality for the ITT population and transplanted patients - Incidences of acute and chronic GVHD;Timepoint(s) of evaluation of this end point: at end of follow-up (month 14) | — |
Countries
Germany
Contacts
Public Contactcoordinating investigator
Johannes Schetelig
Outcome results
None listed