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CLL12

AcronymISRCTNEudraCTClinicaltrials.govDRKS
CLL122013-003211-22

A placebo-controlled, double-blind, randomized, multicenter, three arm phase III study to compare the efficacy and safety of ibrutinib vs placebo in previously untreated early Binet stage A CLL patients with risk of early disease progression

Status: Active (Recruitment Closed)

Purpose / Objectives

Primary Outcome

EFS based on an internal medical review according to iwCLL guidelines

Secondary Outcomes

  • Progression-free survival defined by the time between randomization until active progressive disease with treatment indication according to iwCLL-Guidelines or death.
  • Treatment-free survival defined as the time between randomization until the date of initiation of subsequent treatment for CLL. The accepted indications to initiate treatment are based on the updated iwCLL-guidelines and will be determined by an internal medical review. In addition a sensitivity analysis for TFS will be performed using the time between first CLL diagnosis and the date of initiation of subsequent treatment.
  • Type, response and duration of response to subsequent treatment for CLL
  • To evaluate and compare in the treatment arm: overall response rate, complete response and partial response, best ORR achieved during treatment or within 6 month of end of treatment and duration of response in CR and PR patients
  • To evaluate and compare the safety profile of patients treated with ibrutinib second malignancies
  • Moriskey 8

For low risk patients:

  • Time to first CLL treatment for subjects with low risk will be calculated from completed screening to the date starting the first CLL treatment or death

For all study arms:

  • To determine and compare OS in each study arm defined as the time between randomization for intermediate/(very) high risk patients or completed screening for low risk patients and death due to any cause.
  • To evaluate the relationship between various baseline markers and clinical outcome parameters in patients from all study arms
  • Health-related quality of life by EORTC QLQ C30 and EQ-5D

Diagnosis

Patient attributes

Stage

Binet A without need for treatment

Age

18-99

Inclusion criteria

  • Confirmed diagnosis of previously untreated CLL according to the updated iwCLL guidelines
  • Stage Binet A without need fot treatment
  • Age > 18 years
  • Life expectancy > 6 month
  • ECOG performance status 0 -2
  • Signed written informed consent
  • All parameters for risk stratification present
  • FCBP in the experimental treatment arm must have  one negative medically supervised pregnancy test prior to staring the study therapy (Either commit to contiued abstinence from heterosexual intercourse or agree to use, and be able to comply with , two reliable forms of effective contraception)
  • Male subjects in the experimental treatment arm must agree to use a condom during sexual contact with a FCBP throughout study drug therapy, during any dose interruption and after cessation of study therapy
  • All subjects must have an understanding the the study drug could have a potential teratogenic risk
  • Be counseled about pregnancy precautions and risk of fetal exposure
  • Willingness to inform the genral practicioner

Exclusion criteria

  • Any prior CLL specific therapy
  • Chronic use of steroids in excess of prednisone 20mg/day or its equivalent
  • Active infections requiring systemic antibiotics
  • Pregnant or lactating females
  • CNS involvement as documented by spinal fluid cytology or imaging.
  • Known second malignancy that limits survival to less than 2 years
  • Known HIV, active Hepatitis B Virus and/or active Hepatitis C infection
  • Any of the following laboratory abnormalities: AST, SGOT or ALT > 3.0 x ULN / Serum total bilirubin > 2.0 mg/dl
  • Requires anticoagulant with warfarin or phenoprocoumon
  • History of stroke or intracranial hemorrhage within 6 month prior t randomization
  • Patients with uncontrolled autoimmune hemolytic anemia or autoimmune thrombocytopenia

Trial design

  • Phase III
  • Multicenter
  • Prospective
  • Randomized
  • Double-blind
  • Placebo-controlled

Intervention

Placebo or ibrutinib 420 mg will be administered daily up to active progressive disease with treatment indication according to iwCLL-Guidelines.

The double-blind treatment phase will extend from randomization until study drug discontinuation. Subjects will receive ibrutinib or placebo. A cycle is defined as 28 calender days.

Staging procedures will be done every 3 cycles. Ibrutinib or placebo will continue until active progression disease with treatment indication according  to iwCLL guidelines or unacceptable toxicity.

Documents (password protected)

Responsibilities in overall trial

Universität zu Köln

  • Tel. +49 (0)221 478 0

National Coordinating Investigator

Dr. med. Petra Langerbeins, geb. Jenke

Study Sites

Klinik I für Innere Medizin

Study office

  • Klinisches Studienzentrum der Klinik I für Innere Medizin Köln

Status

Active (Recruitment Closed)

Principal Investigator

Dr. med. Petra Langerbeins, geb. Jenke

Deputy of Principal Investigator

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

Subinvestigator

  • Dr. med. Paula Cramer
  • Dr. med. Nadine Kutsch
  • Priv.-Doz. Dr. med. Bastian von Tresckow
  • PD Dr. med. Thomas Elter
  • Prof. Dr. med. Hans Christian Reinhardt
  • PD Dr. med. Stephanie Sasse
  • PD Dr. med. Thomas Zander
  • Dr. med. Birgit Cremer
  • Prof. Dr. med. Christian Pallasch
  • Dr. med. Armin Tuchscherer
  • Dr. med. Othman Al-Sawaf
  • Univ.-Prof. Dr. med. Dr. rer.-nat. Roland Ullrich
  • Dr. med. Julia von Tresckow, geb. Kilp
  • Dr. med. Janine Böll, geb. Schwamb
  • Dr. med. Anja Jühling
  • Dr. med. Moritz Fürstenau
  • Florian Simon
  • Johanna Prinz
  • Dr. Stefanie Kreissl
  • Dr. med. Carmen Diana Herling
  • Carolin Groß-Ophoff-Müller
  • Dr. med. Ron Jachimowicz
  • Dr. med. Paul Bröckelmann

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