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Clinical Trials/NL-OMON44081
NL-OMON44081
Completed
Phase 3

A phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study of the efficacy and safety of lenalidomide (Revlimid®) as maintenance therapy for high-risk patients with chronic lymphocytic leukemia following first-line therapy - HOVON 121 CLLM1/GCLLSG

HOVO0 sites5 target enrollmentTBD
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Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Not specified
Sponsor
HOVO
Enrollment
5
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

Trial ended prematurely

Registry
who.int
Start Date
TBD
End Date
October 2, 2020
Last Updated
2 years ago
Study Type
Interventional

Investigators

Sponsor
HOVO

Eligibility Criteria

Inclusion Criteria

  • •1\. Must understand and voluntarily sign an informed consent form.
  • •2\. Age \>\= 18 years at the time of signing the informed consent form.
  • •3\. Must be able to adhere to the study visit schedule and other protocol
  • •requirements.
  • •4\. Must have a documented diagnosis of CLL (IWCLL guidelines for the
  • •diagnosis and treatment of chronic lymphocytic leukemia1\).
  • •5\. Must have been treated with one of the first line induction therapies:
  • •fludarabine/cyclophosphamide/rituximab, or bendamustine/rituximab or
  • •fludarabine/rituximab or fludarabine/cyclophosphamide,(in case of
  • •hypersensitivity reactions to Rituximab).

Exclusion Criteria

  • •1\. A CIRS Score of more than 6 or a single score of 4 for an organ system limiting the ability to receive an intensive therapy for CLL
  • •2\. Active infections requiring systemic antibiotics.
  • •3\. Systemic infection CTC grade 3 or 4 that has not resolved \> 2 months prior to randomization in spite of adequate anti\-infective therapy.
  • •4\. Autologous or allogeneic bone marrow transplant as first line therapy.
  • •5\. Pregnant or lactating females.
  • •6\. Systemic treatment for CLL in the interval between completing the last cycle of first\-line induction therapy and randomization.
  • •7\. Participation in any clinical study or having taken any investigational therapy which would interfere with the study drug for a disease other than CLL within 28 days prior to initiating maintenance therapy.
  • •8\. Known presence of alcohol and/or drug abuse.
  • •9\. Central nervous system (CNS) involvement as documented by spinal fluid cytology or imaging. Subjects who have signs or symptoms suggestive of leukemic meningitis or a history of leukemic meningitis must have a lumbar puncture procedure performed within two weeks prior to randomization.
  • •10\. Prior history of malignancies, other than CLL, unless the subject has been free of the disease for \>\=5 years. Exceptions include the folowing:

Outcomes

Primary Outcomes

Not specified

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