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

NCT02156726 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2014-06-05

No results posted yet for this study

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

Interventions

DRUG

low-dose FCR

FCR with attenuated dose of fludarabine and cyclophosphamide

Sponsors & Collaborators

  • Czech CLL Study Group

    lead NETWORK

Principal Investigators

  • Lukáš Smolej, M.D. Ph.D. · Czech CLL Study Group

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2014-10-31
Completion
2015-07-31

Countries

  • Czechia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02156726 on ClinicalTrials.gov