Relapsed or refractory CD20-positive aggressive B-cell lymphomas
Conditions
Interventions
Trade Name: Revlimid
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: LENALIDOMIDE
CAS Number: 191732-72-6
Concentration unit: mg
Sponsors
University Hospital Essen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects must satisfy the following criteria to be enrolled in the study: Age = 18 years Performance status ECOG 1 - 3 First or subsequent relapse or refractoriness of a biopsy-proven CD20-positive aggressive B cell lymphoma (excluding mantle cell lymphoma) Measurable disease Ineligibility or unwillingness to undergo high-dose chemotherapy with autologous stem cell transplantation Ability to understand the aim of the study and act accordingly Subjects should be instructed never to give lenamidomide to another person and to return any unused capsules to the study doctor at the end of treatment. Females of childbearing potential enrolled in this protocol must agree to use two reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual contact during the following time periods related to this study: 1) for at least 28 days before starting study drug; 2) while participating in the study; 3) during dose interruptions; and 4) for at least 28 days after study treatment discontinuation. Signed informed consent 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 28 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 28
Exclusion criteria
Exclusion criteria: The presence of any of the following will exclude a subject from enrolment: Central nervous system relapse of aggressive lymphoma Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study Any condition including the presence of laboratory abnormalities which places the subject at unacceptable risk if he/she were to participate in the study Any condition that confounds the ability to interpret data from the study Inadequate organ function not related to aggressive lymphoma: - neutrophils < 1.0/nl - platelets < 75/nl - creatinine = 2,0 mg/dl - bilirubine = 2,5 mg/dl - serum AST/GOT or ALT/GPT = 4 x upper limit of normal Active viral hepatitis (HBV, HCV), HIV infection, any other uncontrolled infection Pregnancy and nursing period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Phase I: Evaluation of the feasibility, safety and dose-limiting toxicity of the LeMLAR regimen Phase II: Evaluation of the efficacy of the LeMLAR regimen at the maximum tolerated dose ;Secondary Objective: Evaluation of the types of treatment response, their durability, the pattern of relapse, long-term toxicities, secondary malignancies, overall survival; Primary end point(s): Phase I: Dose-limiting toxicity of the combination regimen, determination of the maximum tolerated doses of methotrexate and cytarabine Dose-limiting toxicities: - any of the following on the day of methotrexate/cytarabine injection (day 8 + = 3 days / day 15 + = 6 days of the first or second treatment cycle; day 1 of the second or third cycle which is equivalent to day 29 + = 7 days of the previous cycle): - neutrophils < 500/µl - platelets < 25.000/µl - creatinine = 2,0 mg/dl - bilirubine = 3,0 mg/dl - serum AST/GOT or ALT/GPT = 6 x upper limit of normal - mucositis grade 3 or 4 - requirement for dose reduction of methotrexate/cytarabine in the first or second treatment cycle - fewer than 21 days of lenalidomide in the first or second treatment cycle - toxicity-related delay of second or third treatment cycle by more than 7 days - any other toxicity preventing continuation of therapy according to protocol in the first or second treatment cycle (except allergic reactions) Phase II: Overall response rate (percentage of complete and partial remissions combined) ; Timepoint(s) of evaluation of this end point: Phase I Dose-limiting toxicity will be evaluated during and after the first two treatment cycles | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Rates of stable disease and progressive disease, relapse rate, progression-free survival, event-free survival, disease-free survival, overall survival, toxicity (type, onset, duration), secondary malignancies;Timepoint(s) of evaluation of this end point: The secondary endpoints will be evaluated at the end of treatment (after a minimum of two and a maximum of six cycles) and, in case of time-dependent variables, during the subsequent follow-up period. | — |
Countries
Germany
Contacts
Public ContactHans-Peter Tappe
University Hospital Essen
Outcome results
None listed