TriangleNCT00090051 · CITED IN SOURCE DOCUMENTS
FCR Versus FC Alone in the Treatment of Chronic Lymphocytic Leukemia (CLL) in Relapsed Patients
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- PHASE3
- Status at capture
- COMPLETED
- Registry last update
- 2017-08-01
The purpose of this study is to provide treatment for patients who have chronic lymphocytic leukemia (CLL), and to compare the use of rituximab added to fludarabine+cyclophosphamide (FC) with FC alone, to determine if rituximab lengthens the time a patient remains free of leukemia symptoms.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Participant flow
Baseline characteristics
Progression-free Survival (PFS) as Assessed by the Independent Review Committee (IRC)
Overall Survival (OS)
Number of Participants With Overall Survival (OS) Events
Event-free Survival (EFS)
Number of Participants With Event-free Survival (EFS) Events
Number of Participants With Progression-free Survival (PFS) Events Assessed by the Independent Review Committee (IRC)
Disease-free Survival (DFS)
Number of Participants With Disease-free Survival (DFS) Events
Final Analysis: Time to Progression-Free Survival Event
Final Analysis: Time to Overall Survival Event
Final Analysis: Time to Event-Free Survival Event
Final Analysis: Percentage of Participants With Complete Response
Final Analysis: Time to Disease-Free Survival Event
Final Analysis: Duration of Response
Final Analysis: Time to New Chronic Lymphocytic Leukemia (CLL) Treatment
Adverse events
Limitations, agreements, and source contact
Who could take part
- eligibility Criteria
- Inclusion Criteria: * Age ≥18 years * Established diagnosis of B-cell CLL by NCI Working Group criteria * ≤1 previous line of chemotherapy * Expected survival \>6 months * Acceptable hematologic status, liver function, renal function, and pulmonary function * Negative serum pregnancy test for both pre-menopausal women and for women who are \< 2 years after the onset of menopause * Written informed consent Exclusion Criteria: * Prior treatment with interferon, rituximab or other monoclonal antibody * Prior allogeneic bone marrow transplant (BMT) or autologous BMT or peripheral stem cell transplant (PBSCT) or patients who are considered to be candidates for allogeneic or autologous BMT or PSCT as assessed by their treating physician * Fertile men or women of childbearing potential not using adequate contraception * Severe Grade 3 or 4 non-hematological toxicity or prolonged (\> 2 weeks) Grade 3 or 4 cytopenia on prior fludarabine or nucleoside analogue regimen * History of fludarabine-induced or clinically significant autoimmune cytopenia * History of other malignancies within 2 years prior to study entry, except for adequately treated carcinoma in situ of the cervix; basal or squamous cell skin cancer; low-grade early stage localized prostate cancer treated surgically with curative intent; good prognosis ductal carcinoma in situ (DCIS) of the breast treated with lumpectomy alone with curative intent. * Medical conditions requiring long term use (\> 1 month) of systemic corticosteroids * Active bacterial, viral, or fungal infection requiring systemic therapy * Severe cardiac disease * Seizure disorders requiring anticonvulsant therapy * Severe chronic obstructive pulmonary disease with hypoxemia * Uncontrolled diabetes mellitus or hypertension * Transformation to aggressive B-cell malignancy. * Known infection with HIV, HCV, or hepatitis B * Treatment with any other investigational agent, or participation in another clinical trial within 30 days prior to entering this study * Known hypersensitivity or anaphylactic reactions to murine antibodies or proteins * Any co-existing medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- intervention Names
- Drug: Fludarabine Phosphate
- Drug: Cyclophosphamide
- label
- Fludarabine+Cyclophosphamide (FC)
- type
- ACTIVE_COMPARATOR
- intervention Names
- Drug: Rituximab
- Drug: Fludarabine Phosphate
- Drug: Cyclophosphamide
- label
- Fludarabine+Cyclophosphamide+Rituximab (FCR)
- type
- EXPERIMENTAL
- interventions
- arm Group Labels
- Fludarabine+Cyclophosphamide+Rituximab (FCR)
- description
- Intravenous repeating dose
- name
- Rituximab
- type
- DRUG
- arm Group Labels
- Fludarabine+Cyclophosphamide (FC)
- Fludarabine+Cyclophosphamide+Rituximab (FCR)
- description
- Intravenous repeating dose
- name
- Fludarabine Phosphate
- type
- DRUG
- arm Group Labels
- Fludarabine+Cyclophosphamide (FC)
- Fludarabine+Cyclophosphamide+Rituximab (FCR)
- description
- Intravenous repeating dose
- name
- Cyclophosphamide
- type
- DRUG
Study design
- allocation
- RANDOMIZED
- intervention Model
- PARALLEL
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 552
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- Progression-free survival as assessed by the IRC was defined as the time between randomization and the date of first documented disease progression, relapse after response, or death from any cause, whichever came first. Patients without a PFS event were censored at their last tumor assessment date.
- measure
- Progression-free Survival (PFS) as Assessed by the Independent Review Committee (IRC)
- time Frame
- Mean observation time at time of analysis was approximately 26 months
- description
- Progression-free survival as assessed by the IRC was defined as the time between randomization and the date of first documented disease progression, relapse after response, or death from any cause (PFS events), whichever came first. Patients without a PFS event were censored at their last tumor assessment date.
- measure
- Number of Participants With Progression-free Survival (PFS) Events Assessed by the Independent Review Committee (IRC)
- time Frame
- Mean observation time at time of analysis was approximately 26 months
- description
- Time to progression-free survival (PFS) event was defined as the time between randomization and the date of first documented PFS event: disease progression, relapse or death by any cause, whichever came first.
- measure
- Final Analysis: Time to Progression-Free Survival Event
- time Frame
- Median observation time was approximately 5 years
- secondary Outcomes
- description
- Overall survival was determined from the date of randomization to the date of death irrespective of cause. Patients who had not died at the time of the final analysis (clinical data cut-off) were censored at the date of the last contact.
- measure
- Overall Survival (OS)
- time Frame
- Mean observation time at time of analysis was approximately 26 months
- description
- Overall survival was determined from the date of randomization to the date of death (OS event) irrespective of cause. Patients who had not died at the time of the final analysis (clinical data cut-off) were censored at the date of the last contact.
- measure
- Number of Participants With Overall Survival (OS) Events
- time Frame
- Mean observation time at time of analysis was approximately 26 months
- description
- Event free survival was measured from the day of randomization to the date of first documented PD, relapse after response, start of a new treatment or death from any cause. Patients without an EFS event were censored at their last tumor assessment date.
- measure
- Event-free Survival (EFS)
- time Frame
- Mean observation time at time of analysis was approximately 26 months
- description
- Event free survival was measured from the day of randomization to the date of first documented Progressive Disease (PD), relapse after response, start of a new treatment or death from any cause (EFS events). Patients without an EFS event were censored at their last tumor assessment date.
- measure
- Number of Participants With Event-free Survival (EFS) Events
- time Frame
- Mean observation time at time of analysis was approximately 26 months
- description
- Disease free survival was defined for all patients with a best overall response (BOR) of Complete Response (CR) and measured the time from first documented CR in a sequence of consecutive CRs until documented disease progression, relapse or death from any cause. Patients without a DFS event at the time of the analysis (clinical data cut-off) were censored at their last tumor assessment date.
- measure
- Disease-free Survival (DFS)
- time Frame
- Mean observation time at time of analysis was approximately 26 months
- description
- Disease free survival was defined for all patients with a best overall response (BOR) of Complete Response (CR) and measured the time from first documented CR in a sequence of consecutive CRs until documented disease progression, relapse or death from any cause (DFS events). Patients without a DFS event at the time of the analysis (clinical data cut-off) were censored at their last tumor assessment date.
- measure
- Number of Participants With Disease-free Survival (DFS) Events
- time Frame
- Mean observation time at time of analysis was approximately 26 months
- description
- Overall survival (OS) was determined from the date of randomization to the date of death (OS event) irrespective of cause.
- measure
- Final Analysis: Time to Overall Survival Event
- time Frame
- Median observation time was approximately 5 years
- description
- Event free survival (EFS) was defined as the time from the day of randomization to the date of first EFS event: documented disease progression, relapse after response, start of a new treatment or death from any cause.
- measure
- Final Analysis: Time to Event-Free Survival Event
- time Frame
- Median observation time was approximately 5 years
- description
- Complete response was defined as the disappearance of all signs of cancer in response to treatment.
- measure
- Final Analysis: Percentage of Participants With Complete Response
- time Frame
- Median observation time was approximately 5 years
- description
- Time to disease-free survival (DFS) event was defined as the time from first documented response until the first documented DFS event: disease progression, relapse or death from any cause.
- measure
- Final Analysis: Time to Disease-Free Survival Event
- time Frame
- Median observation time was approximately 5 years
- description
- Duration of response was defined as the time between the date of the earliest qualifying response and the date of disease progression or death due to any cause.
- measure
- Final Analysis: Duration of Response
- time Frame
- Median observation time was approximately 5 years
- description
- Time to new CCL treatment was defined as the time from randomization to the first day of new treatment for CCL or death.
- measure
- Final Analysis: Time to New Chronic Lymphocytic Leukemia (CLL) Treatment
- time Frame
- Median observation time was approximately 5 years
Full study description
- brief Summary
- The purpose of this study is to provide treatment for patients who have chronic lymphocytic leukemia (CLL), and to compare the use of rituximab added to fludarabine+cyclophosphamide (FC) with FC alone, to determine if rituximab lengthens the time a patient remains free of leukemia symptoms.
Source references
- references
- citation
- Weisser M, Yeh RF, Duchateau-Nguyen G, Palermo G, Nguyen TQ, Shi X, Stinson SY, Yu N, Dufour A, Robak T, Salogub GN, Dmoszynska A, Solal-Celigny P, Warzocha K, Loscertales J, Catalano J, Larratt L, Rossiev VA, Bence-Bruckler I, Geisler CH, Montillo M, Fischer K, Fink AM, Hallek M, Bloehdorn J, Busch R, Benner A, Dohner H, Valente N, Wenger MK, Stilgenbauer S, Dornan D. PTK2 expression and immunochemotherapy outcome in chronic lymphocytic leukemia. Blood. 2014 Jul 17;124(3):420-5. doi: 10.1182/blood-2013-12-538975. Epub 2014 Jun 10.
- pmid
- 24916506
- type
- DERIVED
- citation
- Dufour A, Palermo G, Zellmeier E, Mellert G, Duchateau-Nguyen G, Schneider S, Benthaus T, Kakadia PM, Spiekermann K, Hiddemann W, Braess J, Truong S, Patten N, Wu L, Lohmann S, Dornan D, GuhaThakurta D, Yeh RF, Salogub G, Solal-Celigny P, Dmoszynska A, Robak T, Montillo M, Catalano J, Geisler CH, Weisser M, Bohlander SK. Inactivation of TP53 correlates with disease progression and low miR-34a expression in previously treated chronic lymphocytic leukemia patients. Blood. 2013 May 2;121(18):3650-7. doi: 10.1182/blood-2012-10-458695. Epub 2013 Mar 22.
- pmid
- 23525797
- type
- DERIVED
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Preserved source evidence · Not medical advice