TriangleNCT00281918 · CITED IN SOURCE DOCUMENTS
Fludarabine and Cyclophosphamide With or Without Rituximab in Patients With Previously Untreated Chronic B-Cell Lymphocytic Leukemia
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
- 2013-09-19
This randomized phase III trial is studying fludarabine, cyclophosphamide, and rituximab to see how well they work compared to fludarabine and cyclophosphamide in treating patients with B-cell chronic lymphocytic leukemia.
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)
Event-free Survival (EFS)
Overall Survival (OS)
Disease-free Survival (DFS) of Patients With Confirmed Complete Response (CR).
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: Time to Disease-free Survival (DFS) Event in Participants With Complete Response (CR)
Final Analysis: Duration of Response
Final Analysis: Percentage of Participants With Complete Response (CR) and Partial Response
Final Analysis: Time to New Treatment for Chronic Lymphocytic Leukemia(CLL)
Adverse events
Limitations, agreements, and source contact
Who could take part
- eligibility Criteria
- DISEASE CHARACTERISTICS: * Diagnosed B-cell chronic lymphocytic leukemia (CLL) defined by the National Cancer Institute (NCI) Working Group criteria * Meets 1 of the following criteria: * Binet stage C disease * Binet stage B disease AND ≥ 1 of the following signs or symptoms\*: * B symptoms (night sweats, weight loss ≥ 10% within the previous 6 months, fevers \> 38°C or 100.4°F for ≥ 2 weeks without evidence of infection), or constitutional symptoms (fatigue) * Continuous progression (doubling of peripheral lymphocyte count within the past 6 months and absolute lymphocyte count \> 50 G/I) * Evidence of progressive marrow failure as manifested by the development/worsening of anemia and/or thrombocytopenia * Massive, progressive or painful splenomegaly or hypersplenism * Massive lymph nodes or lymph node clusters (\> 10 cm in longest diameter), danger of organ complications through large lymphoma (e.g., vascular compression or tracheal narrowing), or progressive lymphadenopathy * Occurrence of symptomatic hyperviscosity problems at leukocyte counts \> 200 G/I (symptomatic leukostasis) NOTE: \* Marked hypogammaglobulinemia or the development of a monoclonal protein in the absence of any of the above criteria for active disease is not sufficient for eligibility * No Binet stage A disease * No transformation to an aggressive B-cell malignancy (e.g., diffuse large cell lymphoma, Richter's syndrome, or prolymphocytic leukemia) PATIENT CHARACTERISTICS: * Eastern Cooperative Oncology Group (ECOG) performance status 0-1 * Cumulative Illness Rating Scale (CIRS) score \> 6 * Life expectancy \> 6 months * Bilirubin ≤ 2 times upper limit of normal (ULN) * Alkaline phosphatase and transaminases ≤ 2 times ULN * Creatinine clearance ≥ 70 mL/min * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 2 months after study treatment * No known hypersensitivity with anaphylactic reaction to humanized monoclonal antibodies or any of the study drugs * No cerebral dysfunction that precludes chemotherapy * No active bacterial, viral, or fungal infection * No clinically significant autoimmune cytopenia or Coombs-positive hemolytic anemia * No other active malignancy requiring concurrent treatment except basal cell carcinoma or tumors treated curatively by surgery * No medical or psychological condition that would preclude study therapy * No concurrent disease that requires prolonged (\> 1 month) therapy involving glucocorticoids PRIOR CONCURRENT THERAPY: * No previous treatment of CLL by chemotherapy, radiotherapy, or immunotherapy
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- intervention Names
- Drug: Rituximab
- Drug: Cyclophosphamide
- Drug: Fludarabine Phosphate
- label
- Fludarabine+Cyclophosphamide+Rituximab (FCR)
- type
- EXPERIMENTAL
- intervention Names
- Drug: Cyclophosphamide
- Drug: Fludarabine Phosphate
- label
- Fludarabine+Cyclophosphamide (FC)
- type
- ACTIVE_COMPARATOR
- 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
- Cyclophosphamide
- type
- DRUG
- arm Group Labels
- Fludarabine+Cyclophosphamide (FC)
- Fludarabine+Cyclophosphamide+Rituximab (FCR)
- description
- Intravenous repeating dose
- name
- Fludarabine Phosphate
- type
- DRUG
Study design
- allocation
- RANDOMIZED
- intervention Model
- PARALLEL
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 817
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- Progression-free survival (PFS) was defined as the time between randomization and the date of first documented disease progression, relapse or death by any cause, whichever came first.
- measure
- Progression-free Survival (PFS)
- time Frame
- Median observation time at time of analysis was approximately 21 months
- description
- Progression-free survival was defined as the time between randomization and the date of first documented 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 66.4 months
- secondary Outcomes
- description
- Event-free survival (EFS) was defined as the time between randomization and the date of disease progression, relapse, start of new CLL treatment or death by any cause.
- measure
- Event-free Survival (EFS)
- time Frame
- Median observation time at time of analysis was approximately 21 months
- description
- Overall survival (OS) was defined as the time between randomization and the date of death due to any cause. Median OS was not reached.
- measure
- Overall Survival (OS)
- time Frame
- Median observation time at time of analysis was approximately 21 months
- description
- CR is defined by at least 8 weeks of: 1)Absence of lymphadenopathy 2)No hepatomegaly or splenomegaly 3)Absence of B-symptoms 4)Normal blood count 5)Bone marrow aspirate and biopsy 8 weeks after the clinical and laboratory results demonstrated that a CR was achieved. A marrow sample had to be normocellular for age with less than 30% lymphocytes. Lymphoid nodules had to be absent. If marrow was hypocellular,a repeat biopsy was taken 4 weeks later and samples were re-reviewed in conjunction with the prior pathology. DFS was calculated from time of CR to relapse or death. Median DFS was not reached.
- measure
- Disease-free Survival (DFS) of Patients With Confirmed Complete Response (CR).
- time Frame
- Median observation time at time of analysis was approximately 21 months
- description
- Overall survival (OS) was defined as the time between randomization and the date of death due to any cause.
- measure
- Final Analysis: Time to Overall Survival Event
- time Frame
- Median observation time was approximately 66.4 months
- description
- Event-free survival was defined as the time between randomization and the date of disease progression, relapse, start of new Chronic Lymphocytic Leukemia treatment or death by any cause.
- measure
- Final Analysis: Time to Event-free Survival Event
- time Frame
- Median observation time was approximately 66.4 months
- description
- CR is defined by at least 8 weeks of: 1)Absence of lymphadenopathy 2)No hepatomegaly or splenomegaly 3)Absence of B-symptoms 4)Normal blood count 5)Bone marrow aspirate and biopsy 8 weeks after the clinical and laboratory results demonstrated that a CR was achieved. A marrow sample had to be normocellular for age with less than 30% lymphocytes. Lymphoid nodules had to be absent. If marrow was hypocellular,a repeat biopsy was taken 4 weeks later and samples were re-reviewed in conjunction with the prior pathology. DFS was calculated from time of CR to relapse or death
- measure
- Final Analysis: Time to Disease-free Survival (DFS) Event in Participants With Complete Response (CR)
- time Frame
- Median observation time was approximately 66.4 months
- description
- Duration of response was defined as the time from the first documented Complete Response, Partial Response to disease progression or death by any cause.
- measure
- Final Analysis: Duration of Response
- time Frame
- Median observation time was approximately 66.4 months
- description
- CR is defined by at least 8 weeks of: 1)Absence of lymphadenopathy 2)No hepatomegaly or splenomegaly 3)Absence of B-symptoms 4)Normal blood count 5)Bone marrow aspirate and biopsy 8 weeks after the clinical and laboratory results demonstrated that a CR was achieved. A marrow sample had to be normocellular for age with less than 30% lymphocytes. Lymphoid nodules had to be absent. If marrow was hypocellular,a repeat biopsy was taken 4 weeks later and samples were re-reviewed in conjunction with the prior pathology. Partial response is defined as a decrease in the size of a tumor, or in the extent of cancer in the body, in response to treatment.
- measure
- Final Analysis: Percentage of Participants With Complete Response (CR) and Partial Response
- time Frame
- Median observation time was approximately 66.4 months
- description
- The time from randomization to the start of a new treatment.
- measure
- Final Analysis: Time to New Treatment for Chronic Lymphocytic Leukemia(CLL)
- time Frame
- Median observation time was approximately 66.4 months
Full study description
- brief Summary
- This randomized phase III trial is studying fludarabine, cyclophosphamide, and rituximab to see how well they work compared to fludarabine and cyclophosphamide in treating patients with B-cell chronic lymphocytic leukemia.
Source references
- references
- citation
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- 24797299
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- Stilgenbauer S, Schnaiter A, Paschka P, Zenz T, Rossi M, Dohner K, Buhler A, Bottcher S, Ritgen M, Kneba M, Winkler D, Tausch E, Hoth P, Edelmann J, Mertens D, Bullinger L, Bergmann M, Kless S, Mack S, Jager U, Patten N, Wu L, Wenger MK, Fingerle-Rowson G, Lichter P, Cazzola M, Wendtner CM, Fink AM, Fischer K, Busch R, Hallek M, Dohner H. Gene mutations and treatment outcome in chronic lymphocytic leukemia: results from the CLL8 trial. Blood. 2014 May 22;123(21):3247-54. doi: 10.1182/blood-2014-01-546150. Epub 2014 Mar 20.
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- 24652989
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- Eichhorst BF, Fischer K, Fink AM, Elter T, Wendtner CM, Goede V, Bergmann M, Stilgenbauer S, Hopfinger G, Ritgen M, Bahlo J, Busch R, Hallek M; German CLL Study Group (GCLLSG). Limited clinical relevance of imaging techniques in the follow-up of patients with advanced chronic lymphocytic leukemia: results of a meta-analysis. Blood. 2011 Feb 10;117(6):1817-21. doi: 10.1182/blood-2010-04-282228. Epub 2010 Dec 7.
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Source notices and limitations
Discovery and provenance
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Preserved source evidence · Not medical advice