Clinical trial NCT02080884: An Observational Study Examining the Effect of Added MabThera Therapy in Patients With Untreated Chronic Lymphocytic Leukemia
Official title: A MULTICENTER NON-INTERVENTIONAL STUDY EVALUATING THE BENEFIT OF THE COMBINATION OF MABTHERA (RITUXIMAB) WITH STANDARD CHEMOTHERAPEUTIC REGIMENS IN PATIENTS WITH PREVIOUSLY UNTREATED CHRONIC LYMPHOCYTIC LEUKEMIA IN HUNGARY
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Lymphocytic Leukemia
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2014-03-06
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with untreated chronic lymphocytic leukemia (CLL)

Brief summary: This study will examine the effectiveness of MabThera therapy added to a standard chemotherapy regimen for the treatment of previously untreated chronic lymphocytic leukemia (CLL). Patients who have received a single prior MabThera plus chemotherapy treatment are eligible. The overall response rate of patients treated for approximately 5 months (as per current label guidelines) will be analysed according to various factors (i.e., age, concurrent treatment, and chromosomal abnormalities).


Eligibility criteria: Inclusion Criteria:

* Diagnosed with first-line CLL having received only 1 cycle of MabThera chemotherapy
* aged \>/= 18 years

Exclusion Criteria:

* Pregnant or breast-feeding
* Receipt of an investigational drug within 30 days prior to entering the study

Primary outcomes:
measure: Overall response rate (ORR) as assessed by the investigator using routine assessment techniques
timeFrame: 7 months
Secondary outcomes:
measure: ORR analysed according to concomitant chemotherapy
timeFrame: 7 months
measure: ORR analysed according to age
timeFrame: 7 months
measure: ORR analysed according to CIRS score
timeFrame: 7 months
measure: ORR analysed according to certain chromosomal abnormalities
timeFrame: 7 months
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Semmelweis University, First Dept of Medicine
city: Budapest
country: Hungary
facility: National Institute of Oncology, A Dept of Internal Medicine
city: Budapest
country: Hungary
facility: Semmelweis Egyetem Aok; Iii.Sz. Belgyogyaszati Klinika
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum; III. Belgyogyaszati Klinika
city: Eger
country: Hungary
facility: Markhot Ferenc Oktato Korhaz es Rendelointezet; III. belgyogyaszat
city: Gyula
country: Hungary
facility: Bekes Megyei Kepviselotestulet Pandy Kalman Korhaza; I. Belgyogyaszat-Hematologia Reszle
city: Miskolc
country: Hungary
facility: Miskolci Semmelweis Kórház és Egyetemi Oktatókórház; Haematology Dept.
city: Nyíregyháza
country: Hungary
facility: Josa Andras Korhaz; Ii. Sz. Belgyogyaszati Es Haematologiai Osztaly
city: Pecs
country: Hungary
facility: University of Pecs, I st Dept of Internal Medicine
city: Szeged
country: Hungary
facility: Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ; Neurológiai Klinika
city: Szolnok
country: Hungary
facility: Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház; Onkológiai Osztály
city: Szombathely
country: Hungary
facility: Vas Megyei Markusovszky Korhaz; Haematologiai Osztaly
city: Székesfehérvár
country: Hungary
facility: Fejér Megyei Szent György Kórház; Hematologiai Osztaly
city: Tatabanuya
country: Hungary
facility: Szent Borbala Korhaz
city: Veszprem
country: Hungary
facility: Veszprem Megyei Csolnoky Ferenc Korhaz Nonprofit Zrt.
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: