Fludarabine, Cyclophosphamide, and Rituximab Versus Pentostatin, Cyclophosphamide, and Rituximab in Previously Untreated or Treated B-Cell Chronic Lymphocytic Leukemia Patients
- Conditions
- B-Cell Chronic Lymphocytic Leukemia
- Interventions
- Registration Number
- NCT00254163
- Lead Sponsor
- US Oncology Research
- Brief Summary
The purpose of this research study is to find out what effects (good and bad) the combination of Nipent+Cytoxan+Rituxan has on CLL cancer compared to Fludara+Cytoxan+Rituxan. While all of these drugs are approved by the Food and Drug Administration (FDA) for the treatment of other cancers, these combinations are experimental for the treatment of CLL.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 184
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Fludarabine, Cyclophosphamide, and Rituximab Cyclophosphamide Fludarabine, Cyclophosphamide, and Rituximab (dosage based on day in cycle) Fludarabine, Cyclophosphamide, and Rituximab Fludarabine Fludarabine, Cyclophosphamide, and Rituximab (dosage based on day in cycle) Fludarabine, Cyclophosphamide, and Rituximab Rituximab Fludarabine, Cyclophosphamide, and Rituximab (dosage based on day in cycle) Pentostatin, Cyclophosphamide, and Rituximab Cyclophosphamide Pentostatin, Cyclophosphamide, and Rituximab (dosage depends on day in cycle) Pentostatin, Cyclophosphamide, and Rituximab Rituximab Pentostatin, Cyclophosphamide, and Rituximab (dosage depends on day in cycle) Pentostatin, Cyclophosphamide, and Rituximab Pentostatin Pentostatin, Cyclophosphamide, and Rituximab (dosage depends on day in cycle)
- Primary Outcome Measures
Name Time Method Infection Rate 6 cycles of 28-day for FCR and 8 cycles of 21-day for PCR, or until PD, CR, or intolerable toxicity infection=febrile events requiring treatment
- Secondary Outcome Measures
Name Time Method Infective Event Rate 6 cycles of 28-day for FCR and 8 cycles of 21-day for PCR, or until PD, CR, or intolerable toxicity infective events=temperature \>101 without symptoms or temp \<101 with symptoms
Percentage of Patients Hospitalized 6 cycles of 28-day for FCR and 8 cycles of 21-day for PCR, or until PD, CR, or intolerable toxicity Percentage of patients who were hospitalized due to any reasons during the study period.
Hematologic Recovery 2 months post-treatment defined as Hb \>11g/dL and a platelet count \>100 × 10\^3/mm\^3
Mean Absolute Neutrophil Count (ANC) at Post-treatment 2 months post-treatment mean Absolute Neutrophil Count (ANC) measured 2 months (8-10 weeks) following the last dose of study treatment
Complete Remission (CR) 6 cycles of 28-day for FCR and 8 cycles of 21-day for PCR, or until PD, CR, or intolerable toxicity Definitions of response is evaluated using guidelines proposed by the National Cancer Institute-Sponsored Working Group for Chronic Lymphocytic Leukemia.
Complete remission (CR) requires all of the following for a period of at least 2 months:
1. Absence of lymphadenopathy by physical examination and appropriate radiographic techniques. Lymph nodes must be \<1 cm.
2. No evidence of hepatomegaly or splenomegaly.
3. Absence of constitutional symptoms.
4. Normal CBC as exhibited by:
* Polymorphonuclear leukocytes ≥ 1,500/mm\^3
* Platelets \> 100,000/mm\^3
* Hemoglobin \> 11.0 g/dL (untransfused)
5. Bone marrow aspirate and biopsy should be performed 2 months after clinical and laboratory results demonstrate that all of the requirements listed in 1-4 have been met to demonstrate that a CR has been achieved. The marrow sample must be at least normocellular for age, with less than 30% of the nucleated cells being lymphocytes.
Lymphoid nodules should be absent.Objective Remission Rate (ORR) 6 cycles of 28-day for FCR and 8 cycles of 21-day for PCR, or until PD, CR, or intolerable toxicity Complete remission (CR) see Outcome Measure 6. Partial remission (PR) must exhibit criteria 1 and 2 as well as one or more of the remaining features for at least 2 months.
1. ≥50% decrease in peripheral blood lymphocyte count from the pretreatment baseline value.
2. ≥50% reduction in lymphadenopathy.
3. ≥50% reduction in the size of the liver and/or spleen.
4. Polymorphonuclear leukocytes ≥ 1,500/mm\^3 or 50% improvement over baseline.
5. Platelets \>100,000/mm\^3 or 50% improvement over baseline.
6. Hemoglobin \>11.0 g/dL or 50% improvement over baseline without transfusions. Nodular partial remission (nPR) is defined as a CR with persistent bone marrow nodules; Objective Remission (OR) = CR + PR + nPR.Progression-free Survival (PFS) Rate at 1-year 12 months after registered. PFS is measured from the date of randomization to the date of first documented disease progression or date of death, whichever comes first. If a patient neither progresses nor dies, this patient will be censored at last contact date
Progression-free Survival (PFS) Rate at 2-year 24 months after registered. PFS is measured from the date of randomization to the date of first documented disease progression or date of death, whichever comes first. If a patient neither progresses nor dies, this patient will be censored at last contact date.
Trial Locations
- Locations (11)
New York Oncology Hematology, PC
🇺🇸Albany, New York, United States
St Joseph Oncology, Inc
🇺🇸St Joseph, Missouri, United States
Alliance Hematology Oncology PA
🇺🇸Westminster, Maryland, United States
Cancer Care Northwest-South
🇺🇸Spokane, Washington, United States
Texas Oncology Cancer Center-Sugar Land
🇺🇸Sugar Land, Texas, United States
South Texas Cancer Center-McAllen
🇺🇸McAllen, Texas, United States
Cancer Centers of Florida, P.A.
🇺🇸Ocoee, Florida, United States
Northwestern Carolina Oncology Hemato
🇺🇸Hickory, North Carolina, United States
Hope Center
🇺🇸Terre Haute, Indiana, United States
Yakima Valley Mem Hosp/North Star Lodge
🇺🇸Yakima, Washington, United States
Medical Oncology Associates
🇺🇸Kingston, Pennsylvania, United States