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

NCT01788189 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2020-02-26

No results posted yet for this study

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

Interventions

DRUG

Lenalidomide

Sponsors & Collaborators

  • Celgene

    collaborator INDUSTRY

  • University Hospital, Essen

    lead OTHER

Principal Investigators

  • Ulrich Dührsen, MD · Klinik für Hämatologie, Universitätsklinikum Essen

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2020-02-20
Completion
2020-02-20

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01788189 on ClinicalTrials.gov