Lenalidomide, MTX, Ara-C and Rituximab in Relapsed Aggressive B-cell Lymphomas

• Status: Completed
• Trial end date: 2020-02-20
• Target enrollment: 0
• Participant gender: All

Summary

Multicenter prospective open-label non-randomised phase I/II study in patients with relapsed or refractory CD20-positive aggressive lymphomas

Phase I:

Dose escalation of methotrexate and cytarabine (days 1, 8 and 15 of each 28-day cycle) in a 3 + 3 design with fixed doses of lenalidomide (days 1 - 21) and rituximab (day 1), maximum 6 cycles

Phase II:

Treatment of 20 patients at maximum tolerated doses of phase I

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Essen
• Collaborator: Celgene
• Treatments: Cytarabine; Lenalidomide; Methotrexate; Rituximab; Thalidomide

Criteria

Inclusion Criteria:

• Age ≥ 18 years

• Performance status ECOG 0 - 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

• Effective contraception

• Signed informed consent

Exclusion Criteria:

• 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 clearance < 60 ml/min

• bilirubin ≥ 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