Clinical trial · Observational
Observational Study of Low Dose FCR in Elderly/Comorbid CLL/SLL: The Q-lite Project
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| low-dose FCR | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Low dose FCR in Elderly/Comorbid CLL
- description
- low dose FCR
- interventionNames
- Drug: low-dose FCR
Primary outcomes (1)
- measure
- Toxicity
- timeFrame
- 8 months
- description
- Toxicity assessed by CTCAE criteria (myelotoxicity, infections, etc.)
Secondary outcomes (5)
- measure
- Overall response rate
- timeFrame
- 8 months
- measure
- Complete response rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- RESULTSmolej L. Therapy of elderly/comorbid patients with chronic lymphocytic leukemia. Curr Pharm Des. 2012;18(23):3399-405. doi: 10.2174/138161212801227096. PMID 22591390
- DERIVEDSmolej 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