Actively Recruiting
A Prospective Multicenter Phase 2 Study of FCR/BR Alternating With Ibrutinib in Treatment-naive Patients With CLL
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2019-06-10
50
Participants Needed
1
Research Sites
450 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Prospective Multicenter Phase 2 Study of FCR/BR Alternating With Ibrutinib in Treatment-naive Patients With CLL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men or women aged 18 to 75 years
- Diagnosis of CLL or SLL meeting IWCLL criteria
- Treatment-naive patients or with only short-term substandard prior treatments meeting strict conditions
- CLL/SLL requiring treatment defined by worsening anemia, thrombocytopenia, large or symptomatic spleen or lymph nodes, progressive lymphocytosis, extranodal involvement, or constitutional symptoms
- ECOG performance status 0 to 2
- Expected survival of 3 months or more
You will not qualify if you...
- History of malignancy other than CLL within the past year, including CNS lymphoma
- Transformation to large cell lymphoma or progression to prolymphocytic leukemia
- Active autoimmune hemolytic anemia or idiopathic thrombocytopenic purpura needing treatment
- Significant liver or kidney dysfunction beyond specified limits
- Severe or uncontrolled infection
- CNS dysfunction with clinical symptoms
- Serious medical diseases that may affect study participation
- Ongoing uncontrolled bleeding or history of major life-threatening bleeding
- Need for continuous anticoagulation therapy
- Major surgery within 30 days except lymph node biopsy
- Pregnant or breastfeeding women, or women of childbearing potential refusing contraception
- Allergy to any study drugs
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Institute of Hematology & Blood Diseases Hospital Chinese Academy of Medical Sciences & Peking Union Medical College
Tianjin, Tianjin Municipality, China, 30020
Actively Recruiting
Research Team
Z
Zengjun Li
CONTACT
T
Tingyu Wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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