Tests FCR or BR alternating with ibrutinib for chronic lymphocytic leukemia
Tests alternating chemotherapy with ibrutinib in adults newly diagnosed with chronic lymphocytic leukemia.
Plain-language title generated from the registry record
Registry title: A Prospective Multicenter Phase 2 Study of FCR/BR Alternating With Ibrutinib in Treatment-naive Patients With CLL
Key facts
- Where
- Tianjin, ChinaSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT03980002, who can take part
Where in China
- Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical CollegeTianjin, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Institute of Hematology & Blood Diseases Hospital, China
- Trial code
- NCT03980002
- Record updated
- 10 June 2019
- Original description
This is a prospective multicenter phase 2 study designed with the purpose to evaluate the response rate and safety of treatment with FCR/BR alternating with ibrutinib in treatment-naive patients with chronic lymphocytic leukemia.Read full original descriptionShow less
A Prospective Multicenter Phase 2 Study of FCR/BR Alternating With Ibrutinib in Treatment-naive Patients With Chronic Lymphocytic Leukemia
This is a prospective multicenter phase 2 study designed with the purpose to evaluate the response rate and safety of treatment with FCR/BR alternating with ibrutinib in treatment-naive patients with chronic lymphocytic leukemia.
Inclusion: Men or women ≥ 18 years and ≤ 75 of age; Diagnosis of CLL/SLL that meets IWCLL diagnostic criteria; Treatment-naive patients. Those patients received short-term substandard treatment are permitted if meet all the items listed below:; Untreated with combined chemotherapy such as CHOP ,COP and so on; Unteated with chemotherapy regimens including fludarabine and bendamustine; Unteated with Ibrutinib; If treated with chlorambucil or cyclophosphamide,should less than 3 weeks; If treated with interferon, should less than 6 months; No objective response are achieved (PR or CR); CLL/SLL requiring treatment as defined by at least one of the following criteria:; Development of, or worsening of, anemia to Hb<100g/L (non-hemolytic) ; Development of, or worsening of, thrombocytopenia to PLT<100,000/L; Massive (≥ 6 cm below left costal margin), progressive or symptomatic splenomegaly; Massive nodes (≥ 10 cm in longest diameter), or progressive or symptomatic lymphadenopathy ; Progressive lymphocytosis with an increase of > 50% over a 2-month period or lymphocyte-doubling time of < 6 months. Lymphocyte-doubling time may be obtained by linear regression extrapolation of absolute lymphocyte counts obtained at intervals of 2 weeks over an observation period of 2 to 3 months. In patients with initial blood lymphocyte counts of < 30,000/L, LDT should not be used as a single parameter to define treatment indication. In addition, factors contributing to lymphocytosis or lymphadenopathy other than CLL/SLL (eg, infection, use glucocorticoid) should be excluded. f)Symptomatic or functional extranodal sites involved s (eg. Skin,kidney, lungs and so on); g)Constitutional symptoms, defined as any 1 or more of the following disease-related symptoms or signs: i. Unintentional weight loss of ≥ 10% within the previous 6 months ii.Significant fatigue (ie, inability to work or perform usual activities); Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2; Expected to survival period for 3 months or more.
Exclusion: Requirement for continuous anticoagulation drugs; Major surgery within 30 days(excluding lymph node biopsy); History of malignant tumour except CLL in the past 1year(including active central nervous system (CNS) involvement with lymphoma); Have active autoimmune hemolytic anemia or idiopathic thrombocytopenic purpura, and require treatment; Severe or uncontrolled infection; Other serious medical diseases that may affect the study（eg. Uncontrolled diabetes, gastric ulcer, other severe cardiopulmonary disease),and final decided by the investigator; Ongoing and uncontrolled bleeding; History of major life-threatening bleeding, especially due to irreversible cause; Allergy to any drug used in the study; Inadequate hepatic and renal function defined as: AST and ALT >4.0 x upper limit of normal (ULN), bilirubin >2.0 x upper limit of normal (ULN), Adequate renal function defined by serum creatinine >1.5 x upper limit of normal (ULN),unrelated to lymphoma; Pregnant or Lactating women, or women of reproductive age refusal to take contraceptive measures; Transformed to large cell lymphoma manifested by clinical evidence, or progressed to prolymphocytic leukemia(PLL); Central nervous system (CNS) dysfunction with clinical manifestation.