Feasibility and dose-finding study of fixed-dose lenalidomide in conjunction with increasing doses of methotrexate, leucovorin, cytarabine and rituximab in relapsed or refractory CD20-positive aggressive lymphomas
- Conditions
- Relapsed or refractory CD20-positive aggressive B-cell lymphomasTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2012-001891-13-DE
- Lead Sponsor
- niversity Hospital Essen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 56
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method