Untreated chronic lymphocytic leukaemia (CLL) MedDRA version: 14.1 Level: LLT Classification code 10003946 Term: B-Lymphocytic, CLL (Kiel Classification) System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Revlimid 5 mg
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: LENALIDOMIDE
CAS Number: 191732-72-6
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration numbe
Sponsors
Arbeitsgemeinschaft medikamentöse Tumortherapie gemeinnützige GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Signed written informed consent • Male or female = 18 years of age • CLL (as determined by CD23+, CD5+, CD19+) • Treatment indication as defined by the NCI Workshop criteria (see appendix 5 and reference 10) • ECOG = 2 • No previous treatment of the CLL by chemotherapy, radiotherapy (except localized radiotherapy of 1 lymphatic area) or immunotherapy • Life expectancy > 6 months (except prognosis due to high risk CLL) 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 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: Active bacterial, viral or fungal infection Positivity for HIV, Hepatitis B or C Reduced organ functions and bone marrow dysfunction not due to CLL Creatinine clearance of below 30 ml/min Patients with a history of other malignancies within 2 years prior to study entry (except for adequately treated carcinoma in situ of the cervix; basal or squamous cell skin cancer; low grade, early stage localized prostate cancer treated surgically with curative intent; good prognosis DCIS of the breast treated with lumpectomy alone with curative intent) Patients with medical co-morbid conditions that would require long term use (> 1 month) of systemic corticosteroids during study treatment Patients with a history of severe cardiac disease; e.g. NYHA Functional Class III or IV heart failure, myocardial infarction within 6 months, ventricular tachyarrhythmias requiring ongoing treatment, or unstable angina Other known co-morbidity with the potential to dominate survival Transformation to aggressive B-cell malignancy (e.g., large B-cell lymphoma, Richter'ssyndrome, or prolymphocytic leukemia (PLL)) Hypersensitivity with anaphylactic reaction to humanised monoclonal antibodies or any of the applied drugs Concurrent chronic systemic immune therapy, chemotherapy, or hormone therapynot indicated in the study protocol Administration of any investigational agent(s) within 4 weeks prior to entry Pregnancy or lactation Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Tolerability of escalated starting dose ;Secondary Objective: • Establishment of maximal tolerated dose (MTD) of lenalidomide in combination with FR • Time to MTD Safety profile of the FRL combination Response rates in all phases by 4-colour flow cytrometric MRD analysis Risk factor analysis (FISH cytogenetics, CD38/ZAP-70 expression, mutation status) Longitudinal definition of T cell subsets (including prognostic EM T cells and Treg cells) +/- PD1 ;Primary end point(s): Tolerability of escalated starting dose ;Timepoint(s) of evaluation of this end point: - after the first 5 patients finished the first treatment cycle - after LVLS | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Establishment of maximal tolerated dose (MTD) of lenalidomide in combination with FR Time to MTD Safety profile of the FRL combination Response rates in all phases by 4-colour flow cytrometric MRD analysis Risk factor analysis (FISH cytogenetics, CD38/ZAP-70 expression, mutation status) Longitudinal definition of T cell subsets (including prognostic EM T cells and Treg cells) +/- PD1 ;Timepoint(s) of evaluation of this end point: after LVLS | — |
Countries
Austria
Contacts
Public ContactDaniela Wolkersdorfer
Arbeitsgemeinschaft medikamentöse Tumortherapie gemeinnützige GmbH
Outcome results
None listed