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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02156726
Recruitment Status : Unknown
Verified May 2014 by Czech CLL Study Group.
Recruitment status was:  Active, not recruiting
First Posted : June 5, 2014
Last Update Posted : June 5, 2014
Sponsor:
Information provided by (Responsible Party):
Czech CLL Study Group

Study Description
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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.

Condition or disease Intervention/treatment
Chronic Lymphocytic Leukemia Drug: low-dose FCR

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.

Study Design
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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Retrospective
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 Start Date : March 2011
Estimated Primary Completion Date : October 2014
Estimated Study Completion Date : July 2015

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Low dose FCR in Elderly/Comorbid CLL
low dose FCR
 Drug: low-dose FCR
FCR with attenuated dose of fludarabine and cyclophosphamide
Other Names:
  • Fludarabine
  • Cyclophosphamide
  • Rituximab


Outcome Measures
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Primary Outcome Measures :
  1. Toxicity [ Time Frame: 8 months ]
    Toxicity assessed by CTCAE criteria (myelotoxicity, infections, etc.)


Secondary Outcome Measures :
  1. Overall response rate [ Time Frame: 8 months ]
  2. Complete response rate [ Time Frame: 8 months ]
  3. Progression-free survival [ Time Frame: 3 years ]
  4. Overall survival [ Time Frame: 3 years ]
  5. Quality of life [ Time Frame: 3 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with CLL or SLL deemed unfit for full-dose FCR. Both untreated and relapsed/refractory setting.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02156726


Locations
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Czech Republic
Department of Hematology - Oncology, University Hospital
Brno, Czech Republic, 60500
Department of Hemato-Oncology, University Hospital
Olomouc, Czech Republic, 77520
Department of Hematology, University Hospital
Plzen, Czech Republic, 30599
Department of Medicine - Hematology, University Hospital Kralovske Vinohrady
Praha, Czech Republic, 10034
1st Department of Medicine - Hematology, University General Hospital
Praha, Czech Republic, 12808
Institute for Hematology and Blood Transfusion
Praha, Czech Republic, 12820
4th Department of Medicine - Hematology, University Hospital
Hradec Kralove, ČR, Czech Republic, 50005
Sponsors and Collaborators
Czech CLL Study Group
Investigators
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Study Chair: Lukáš Smolej, M.D. Ph.D. Czech CLL Study Group
More Information
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Additional Information:

Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Czech CLL Study Group
ClinicalTrials.gov Identifier: NCT02156726    
Other Study ID Numbers: Q-lite
First Posted: June 5, 2014    Key Record Dates
Last Update Posted: June 5, 2014
Last Verified: May 2014
Keywords provided by Czech CLL Study Group:
chronic lymphocytic leukemia
fludarabine
rituximab
elderly
 comorbid
FCR
CIRS
Additional relevant MeSH terms:
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Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Chronic Disease
Disease Attributes
 Pathologic Processes
Cyclophosphamide
Fludarabine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists