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Klinische Studien

CLLM1

AcronymISRCTNEudraCTClinicaltrials.govDRKS
CLLM12011-004698-98NCT01556776

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

Status: Active

Purpose / Objectives

Primary Outcome

  • progression free survival

Secondary Outcomes

  • Overall survival
  • MRD levels after 12 and 24 months
  • Duration of remission
  • QoL

 

Diagnosis

after firstline therapy

Patient attributes

Inclusion criteria

  • Treatment with one of the firstline induction therapies: fludarabine/cyclophosphamide, fludarabine/rituximab, fludarabine/cyclophosphamide/rituximab or bendamustine/rituximab
  • Response of at least PR (IWCLL guidelines for the diagnosis and treatment of chronic lymphocytic leukemia [Hallek, 2008])
  • MRD levels in the peripheral blood at final restaging of  >10-2 or ≥10-4 - <10-2 combined with at least one of the following factors: an unmutated IGHV-status, 17p-deletion or, TP53 mutation

Exclusion criteria

  • A CIRS > 6 or a single score of 4 for an organ system
  • Active infections requiring systemic antibiotics.
  • Autologous or allogeneic bone marrow transplant as first line therapy
  • History of renal failure requiring dialysis
  • Positive serological Hepatitis B test, positive testing of Hepatitis C RNA, positive HIV test within 6 weeks prior to registration
  • Prior therapy with lenalidomide
  • Any of the following laboratory abnormalities: Calculated (method of Cockroft-Gault) creatinine clearance of <60 mL/min, ANC < 1,000/μL, Platelet count < 50,000/μL, AST/SGOT or ALT/SGPT > 3.0 x ULN, Serum total bilirubin > 2.0 mg/dL (with the exception of Gilbert’s Syndrome)
  • Uncontrolled hyperthyroidism or hypothyroidism
  • Venous thromboembolism within one year
  • ≥ Grade-2 neuropathy
  • Uncontrolled autoimmune hemolytic anemia or thrombocytopenia
  • Disease transformation (active) (i.e. Richter’s Syndrome, prolymphocytic leukemia)
  • Known allergy to allopurinol and bulky disease

Trial design

  • Phase III
  • Multicenter
  • Randomized
  • Two-arm
  • Double-blind
  • Placebo-controlled

Documents (password protected)

Responsibilities in overall trial

Universität zu Köln

  • Tel. +49 (0)221 478 0

National Coordinating Investigator

Prof. Dr. med. Barbara Eichhorst

Study Sites

Sozialstiftung Bamberg Klinikum am Bruderwald

Address
Sozialstiftung Bamberg Klinikum am Bruderwald
Sozialstiftung Bamberg
Klinikum am Bruderwald
Buger Str. 80
96049 Bamberg

Study office

Status

Active

Principal Investigator

Prof. Dr. med. Roland Repp

Subinvestigator

  • Dr. med. Christoph Schweizer

Contact at Site