Direkt zum Inhalt | Direkt zur Navigation

Benutzerspezifische Werkzeuge

Sektionen
Studienregister
Sie sind hier: Startseite / Klinische Studien / Studienregister

Studienregister

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 (Recruitment Closed)

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

Klinik I für Innere Medizin

Study office

  • Klinisches Studienzentrum der Klinik I für Innere Medizin Köln

Status

Active (Recruitment Closed)

Principal Investigator

Prof. Dr. med. Barbara Eichhorst

Deputy of Principal Investigator

  • Univ.-Prof. Dr. med. Michael Hallek

Subinvestigator

  • Dr. med. Armin Tuchscherer
  • Dr. med. Julia von Tresckow, geb. Kilp
  • PD Dr. med. Thomas Zander
  • PD Dr. med. Stephanie Sasse
  • Priv.-Doz. Dr. med. Bastian von Tresckow
  • Dr. med. Nadine Kutsch
  • Dr. med. Birgit Cremer
  • Dr. med. Moritz Fürstenau

Contact at Site