Observational Study of Low Dose FCR in Elderly/Comorbid CLL/SLL: The Q-lite Project

NCT02156726 | Unknown

• 1 other identifier: Q-lite
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 7

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.

Conditions

Chronic Lymphocytic Leukemia

Keywords

chronic lymphocytic leukemia; fludarabine; rituximab; elderly; comorbid; FCR; CIRS

Outcome Measures

Primary Outcomes (1)

• Toxicity

  Toxicity assessed by CTCAE criteria (myelotoxicity, infections, etc.)

  8 months

Secondary Outcomes (5)

• Overall response rate

  8 months

• Complete response rate

  8 months

• Progression-free survival

  3 years

• Overall survival

  3 years

• Quality of life

  3 years

Study Arms (1)

Low dose FCR in Elderly/Comorbid CLL

low dose FCR

Drug: low-dose FCR

Interventions

low-dose FCR DRUG

FCR with attenuated dose of fludarabine and cyclophosphamide

Also known as: Fludarabine, Cyclophosphamide, Rituximab

Low dose FCR in Elderly/Comorbid CLL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with CLL or SLL deemed unfit for full-dose FCR. Both untreated and relapsed/refractory setting.

You may qualify if:

• 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

You may not qualify if:

• patients treated with low dose FCR within prospective clinical trials

Sponsors & Collaborators

• Czech CLL Study Group: lead

Study Sites (7)

Department of Hematology - Oncology, University Hospital

Brno, 60500, Czechia

Location

Department of Hemato-Oncology, University Hospital

Olomouc, 77520, Czechia

Location

Department of Hematology, University Hospital

Pilsen, 30599, Czechia

Location

Department of Medicine - Hematology, University Hospital Kralovske Vinohrady

Prague, 10034, Czechia

Location

1st Department of Medicine - Hematology, University General Hospital

Prague, 12808, Czechia

Location

Institute for Hematology and Blood Transfusion

Prague, 12820, Czechia

Location

4th Department of Medicine - Hematology, University Hospital

Hradec Králové, ČR, 50005, Czechia

Location

Related Publications (2)

• Smolej L. Therapy of elderly/comorbid patients with chronic lymphocytic leukemia. Curr Pharm Des. 2012;18(23):3399-405. doi: 10.2174/138161212801227096.

  PMID: 22591390 RESULT

• 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.

  PMID: 33618437 DERIVED

Related Links

• Czech CLL Study Group

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

Receptors, Fc; fludarabine; Cyclophosphamide; Rituximab

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins; Proteins; Amino Acids, Peptides, and Proteins; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins

Study Officials

• Lukáš Smolej, M.D. Ph.D.

  Czech CLL Study Group

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2014
• First Posted: June 5, 2014
• Study Start: March 1, 2011
• Primary Completion: October 1, 2014
• Study Completion: July 1, 2015
• Last Updated: June 5, 2014

Record last verified: 2014-05

Locations

CZ (7)