Clinical trial NCT02156726: Observational Study of Low Dose FCR in Elderly/Comorbid CLL/SLL: The Q-lite Project
Official title: Observational Study of Low Dose FCR in the Treatment of Elderly/Comorbid Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma: The Q-lite Project
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Lymphocytic Leukemia
Keywords: chronic lymphocytic leukemia
fludarabine
rituximab
elderly
comorbid
FCR
CIRS
Lead sponsor: Czech CLL Study Group
Sponsor class: NETWORK
First posted: 2014-06-05
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with CLL or SLL deemed unfit for full-dose FCR. Both untreated and relapsed/refractory setting.

Brief summary: FCR (fludarabine, cyclophosphamide, rituximab) combination is currently accepted as the gold standard in treatment of younger and physically fit CLL patients. These excellent results, however, cannot be generally applied to the whole CLL population. This is because the median age at diagnosis of CLL lies between 65 and 72 years and patients older than 65 years in fact account up to 50%-75 % of the CLL population. Nevertheless, such population is considerably underrepresented in most of the large clinical trials in CLL/SLL. Therefore, it is not clear whether elderly/comorbid patients could profit from newer treatment approaches such as purine analog combinations or chemoimmunotherapy. Several publications demonstrated unacceptable toxicity of full-dose FC/FCR in elderly CLL patients. However, regimens using attenuated doses of fludarabine and cyclophosphamide showed promising efficacy and low toxicity.

Detailed description: The objective of this observational study is to provide additional data to confirm the safety profile and efficacy of low dose FCR for CLL patients treated in clinical practice.

Specific data of interest are: comorbid concitions, concomitant medication, CLL characteristics, prior treatment regimens, adverse events, reasons for discontinuation low dose FCR, overal response rates, complete response rate, progression-free survival, overall survival.

This is an observational, non-interventional, medical record review study in CLL patients. A total of 200 patients with CLL who have been previously treated with low dose FCR will be eligible for the study.

Eligibility criteria: Inclusion Criteria:

* confirmed diagnosis of CLL or SLL
* previously treated by low dose FCR for active disease requiring treatment per IWCLL criteria
* dose reduction of fludarabine and cyclophosphamide due to age, comorbid conditions, or reduce creatinine clearance

Exclusion Criteria:

* patients treated with low dose FCR within prospective clinical trials

Primary outcomes:
measure: Toxicity
timeFrame: 8 months
Secondary outcomes:
measure: Overall response rate
timeFrame: 8 months
measure: Complete response rate
timeFrame: 8 months
measure: Progression-free survival
timeFrame: 3 years
measure: Overall survival
timeFrame: 3 years
measure: Quality of life
timeFrame: 3 years
Other outcomes:
Locations:
city: Brno
country: Czech Republic
facility: Department of Hematology - Oncology, University Hospital
city: Olomouc
country: Czech Republic
facility: Department of Hemato-Oncology, University Hospital
city: Plzen
country: Czech Republic
facility: Department of Hematology, University Hospital
city: Praha
country: Czech Republic
facility: Department of Medicine - Hematology, University Hospital Kralovske Vinohrady
city: Praha
country: Czech Republic
facility: 1st Department of Medicine - Hematology, University General Hospital
city: Praha
country: Czech Republic
facility: Institute for Hematology and Blood Transfusion
city: Hradec Kralove
country: Czech Republic
facility: 4th Department of Medicine - Hematology, University Hospital
state: ČR
Study officials:
affiliation: Czech CLL Study Group
name: Lukáš Smolej, M.D. Ph.D.
role: STUDY_CHAIR
References:
citation: Smolej L. Therapy of elderly/comorbid patients with chronic lymphocytic leukemia. Curr Pharm Des. 2012;18(23):3399-405. doi: 10.2174/138161212801227096.
citation: Smolej L, Brychtova Y, Cmunt E, Doubek M, Spacek M, Belada D, Simkovic M, Stejskal L, Zygulova I, Urbanova R, Brejcha M, Zuchnicka J, Mocikova H, Kozak T; Czech CLL Study Group. Low-dose fludarabine and cyclophosphamide combined with rituximab in the first-line treatment of elderly/comorbid patients with chronic lymphocytic leukaemia/small lymphocytic lymphoma (CLL/SLL): long-term results of project Q-lite by the Czech CLL Study Group. Br J Haematol. 2021 May;193(4):769-778. doi: 10.1111/bjh.17373. Epub 2021 Feb 22.