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

NCT01788189 | Completed Phase 1

• 1 other identifier: EudraCT No. 2012-001891-13
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

B-cell Lymphoma

Keywords

Lymphoma; CD20; Relapse; Lenalidomide

Outcome Measures

Primary Outcomes (1)

• Dose-limiting toxicity

  Phase I: Dose-limiting toxicity of the combination regimen, determination of the maximum tolerated doses of methotrexate and cytarabine Phase II: Overall response rate (percentage of complete and partial remissions combined)

  Two months

Secondary Outcomes (1)

• Progression-free survival

  1 year

Other Outcomes (10)

• Relapse rate

  1 year

• Event-free survival

  1 year

• Disease-free survival

  1 year

Study Arms (1)

Lenalidomide

EXPERIMENTAL

The LeMLAR protocol: Lenalidomide 25 mg p.o., days 1 - 21; Methotrexate 30 - 60 - 90 - 120 - 150 mg/m² i.v. bolus, days 1, 8, 15; Leucovorin 4 x 45 mg p.o. (every 6 hrs), days 2, 9, 16; Cytarabine (Ara-C) 75 - 150 - 225 - 300 - 375 mg/m² i.v. bolus, days 1, 8, 15; Rituximab 375 mg/m² i.v. infusion, day 1. 28-day cycles, maximum 6 cycles, definition of dose-limiting toxicity in cycles 1 and 2, intra-patient dose escalation after cycles 2 and 4 in case of absence of dose-limiting toxicity in previous cycles

Drug: Lenalidomide

Interventions

Lenalidomide DRUG

Lenalidomide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Essen: lead
• Celgene: collaborator

Study Sites (1)

Klinik für Hämatologie, Universitätsklinikum Essen

Essen, 45147, Germany

Location

MeSH Terms

Conditions

Lymphoma, B-Cell; Lymphoma; Recurrence

Interventions

Lenalidomide

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Ulrich Dührsen, MD

  Klinik für Hämatologie, Universitätsklinikum Essen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med.

Study Record Dates

• First Submitted: February 4, 2013
• First Posted: February 11, 2013
• Study Start: January 1, 2013
• Primary Completion: February 20, 2020
• Study Completion: February 20, 2020
• Last Updated: February 26, 2020

Record last verified: 2020-02

Locations

DE (1)