NCT01118234

Brief Summary

The purpose of the study is to evaluate the ability of Rituximab maintenance therapy to prolong progression free survival in patients with chronic lymphocytic leukemia, who responded to a Rituximab induction therapy.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
256

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Dec 2009

Longer than P75 for phase_3

Geographic Reach
3 countries

22 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 3, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 6, 2010

Completed
7.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

January 9, 2020

Status Verified

January 1, 2020

Enrollment Period

8.2 years

First QC Date

May 3, 2010

Last Update Submit

January 6, 2020

Conditions

Chronic Lymphocytic Leukemia

Keywords

CLLRituximabMaintenance

Outcome Measures

Primary Outcomes (1)

  • progression free survival

    Clinical PFS is defined as the period from randomization until disease progression according to the NCI criteria or death due to the underlying disease.

    48 months

Secondary Outcomes (10)

  • MRD (minimal residual disease) progression free survival

    48 months

  • conversion rate to MRD negative

    48 months

  • median MRD levels

    48 months

  • conversation rate to CR

    48 months

  • effect of MRD levels on clinical PFS and OS

    48 months

  • +5 more secondary outcomes

Study Arms (2)

Rituximab

EXPERIMENTAL

Treatment with Rituximab 375 mg/m² every 3 months for 24 months

Drug: Rituximab

Observation

NO INTERVENTION

Observation for 24 months

Interventions

RituximabDRUG

Rituximab (MabThera, F. Hoffmann-La Roche Ltd., Basel, Switzerland) 375 mg/m² every 3 months for 24 months (8 infusions) or observation

Rituximab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • B-CLL
  • Age \>18
  • ECOG performance status 0-2
  • Previous Rituximab containing induction treatment of the CLL in 1st or 2nd line
  • Patient must be in complete remission or partial remission after an induction treatment containing rituximab
  • ANC (absolute neutrophil count) \> 1,0 x 10e9 /L
  • Life expectancy \> 6 months
  • Patient´s written informed consent
  • Patient using a reliable means of contraception for the duration of the treatment including 2 months thereafter

You may not qualify if:

  • Active uncontrolled bacterial, viral or fungal infection
  • Significantly reduced organ functions and bone marrow dysfunction not due to CLL
  • creatinine clearance of below 30mL/min
  • Patients with a history of other malignancies within 2 years prior to study entry
  • Patients with a history of severe cardiac disease
  • Other known comorbidity with the potential to dominate survival
  • Transformation to aggressive B-cell malignancy
  • Hypersensitivity with anaphylactic reaction to humanized monoclonal antibodies or any of the applied drugs
  • Medical condition requiring prolonged (\> 1 month) use of oral corticosteroids
  • Pregnant or breast feeding women
  • Any coexisting medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (22)

Landesklinikum Krems, Hämato-onkologisches Service

Krems, Lower Austria, 3500, Austria

Location

A.ö. Bezirkskrankenhaus Hall in Tirol, Innere Medizin / Hämato - Onkologie

Hall in Tirol, Tyrol, 6060, Austria

Location

Universitätsklinik Innsbruck, Innere MEdizin IV / Hämato-Onkologie

Innsbruck, Tyrol, 6020, Austria

Location

A.ö. Bezirkskrankenhaus Kufstein, Innere Medizin / Hämatologie / Onkologie

Kufstein, Tyrol, 6330, Austria

Location

AKH Linz, Department für Innere Medizin 3

Linz, Upper Austria, 4021, Austria

Location

Landeskrankenhaus Steyr, Innere Medizin, Hämatologie, Onkologie

Steyr, Upper Austria, 4400, Austria

Location

Klinikum Wels-Grieskirchen GmbH, Abteilung für Innere Medizin IV

Wels, Upper Austria, 4600, Austria

Location

LKH Feldkirch, Interne E

Feldkirch, Vorarlberg, 6807, Austria

Location

Universitätsklinik der PMU Salzburg, Univ-Klinik für Innere Medizin

Salzburg, 5020, Austria

Location

AKH Wien, Klinische Abteilung für Hämatologie und Hämostaseologie

Vienna, 1090, Austria

Location

Hanusch Krankenhaus, 3. Med. Abtlg.

Vienna, 1140, Austria

Location

FN Brno

Brno, 62588, Czechia

Location

FN Hradec Kralove

Hradec Králové, 500 05, Czechia

Location

FN Olomouc

Olomouc, Czechia

Location

FN Kralovske Vinohrady

Prague, 10034, Czechia

Location

VFN Praha 2

Prague, 12808, Czechia

Location

F.D. Rossevelt hospital

Banská Bystrica, 97517, Slovakia

Location

Narodny onkologicky ustav

Bratislava, 83310, Slovakia

Location

FNsP sv. Cyrila a Metoda

Bratislava, 85107, Slovakia

Location

FNsP L.Pasteura

Košice, 04190, Slovakia

Location

Martinska fakultna nemocnica

Martin, 03659, Slovakia

Location

FNsP J.A. Reimana

Prešov, 08181, Slovakia

Location

Related Publications (1)

  • Greil R, Obrtlikova P, Smolej L, Kozak T, Steurer M, Andel J, Burgstaller S, Mikuskova E, Gercheva L, Nosslinger T, Papajik T, Ladicka M, Girschikofsky M, Hrubisko M, Jager U, Fridrik M, Pecherstorfer M, Kralikova E, Burcoveanu C, Spasov E, Petzer A, Mihaylov G, Raynov J, Oexle H, Zabernigg A, Flochova E, Palasthy S, Stehlikova O, Doubek M, Altenhofer P, Pleyer L, Melchardt T, Klingler A, Mayer J, Egle A. Rituximab maintenance versus observation alone in patients with chronic lymphocytic leukaemia who respond to first-line or second-line rituximab-containing chemoimmunotherapy: final results of the AGMT CLL-8a Mabtenance randomised trial. Lancet Haematol. 2016 Jul;3(7):e317-29. doi: 10.1016/S2352-3026(16)30045-X. Epub 2016 Jun 16.

    PMID: 27374465DERIVED

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Leukemia, B-CellLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Richard Greil, Prof. Dr.

    Arbeitsgemeinschaft medikamentoese Tumortherapie

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2010

First Posted

May 6, 2010

Study Start

December 1, 2009

Primary Completion

February 1, 2018

Study Completion

July 1, 2019

Last Updated

January 9, 2020

Record last verified: 2020-01

Locations

AU(11)CZ(5)SL(6)