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Clinical Trials/EUCTR2017-002290-19-DE
EUCTR2017-002290-19-DE
Active, not recruiting
Phase 1

A Phase 3b randomized study of lenalidomide (CC-5013) plus rituximab maintenance therapy followed by lenalidomide single-agent maintenance versus rituximab maintenance in subjects with relapsed/refractory follicular, marginal zone or mantle cell lymphoma.

Celgene Corporation0 sites450 target enrollmentStarted: July 25, 2017Last updated:
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Conditionsrelapsed/refractory follicular, marginal zone or mantle cell lymphomaTherapeutic area: Diseases [C] - Cancer [C04]
DrugsRevlimid 2.5mg, hard capsulesRevlimid 5mg, hard capsulesRevlimid 10mg, hard capsulesRevlimid 15mg, hard capsulesRevlimid 20.0 mg, hard capsules

Overview

Phase
Phase 1
Status
Active, not recruiting
Enrollment
450
OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •Age \=18 years
  • •Histologically confirmed Follicular Lymphoma (Grade 1, 2 or 3a), Marginal Zone Lymphoma, or Mantle Cell Lymphoma
  • •Must have documented relapsed, refractory or Progressive Disease after last treatment with systemic therapy
  • •Bi\-dimensionally measurable disease
  • •Eastern Cooperative Oncology Group (ECOG) Performance status \= 2
  • •Adequate bone marrow function
  • •Willingness to follow pregnancy precautions
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes

Exclusion Criteria

  • •Histology other than follicular or marginal zone lymphoma or clinical evidence of transformation or Grade 3b follicular lymphoma
  • •Any medical condition (other than the underlying lymphoma) that requires chronic steroid use
  • •Subjects taking corticosteroids during the last 1 week prior treatment, unless administered at a dose equivalent to \< 20 mg/day of prednisone
  • •Systemic anti\-lymphoma therapy within 28 days or use of antibody agents within 8 weeks use of radioimmunotherapy within 3 months
  • •Known seropositive for or active viral infection with hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV)
  • •Known sensitivity or allergy to murine products
  • •Presence or history of central nervous system involvement by lymphoma. Subjects who are at a risk for a thromboembolic event and are not willing to take prophylaxis for it.
  • •Any condition that places the subject at unacceptable risk if he/she were to participate in the study or that confounds the ability to interpret data from the study.

Investigators

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