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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FCR/BR alternating with ibrutinib | Experimental | FCR/BR→ ibrutinib✖️3months→FCR/BR→ ibrutinib✖️3months→FCR/BR→Maintenance therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FCR and Ibrutinib | Drug | Induction treatment: Patients <65 y and without significant comorbidities are given FCR 1or 2 courses (If patients' white blood cell count <10×10^9/L after first course, the second course can be saved). Then, patients takes ibrutinib orally for 3 months alternating with FCR in 2 cylcles.
|
| Measure | Description | Time Frame |
|---|---|---|
| CRR | Rate of complete remission | 3 months after completion of induction therapy |
| Measure | Description | Time Frame |
|---|---|---|
| ORR | Overall Response Rate | 3 months after completion of induction therapy |
| OS | Overall survival | 5 years |
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Inclusion Criteria:
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:
CLL/SLL requiring treatment as defined by at least one of the following criteria:
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 Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zengjun Li | Contact | +86 13642138692 | lizengjun@ihcams.ac.cn | |
| Tingyu Wang | Contact | +86 15692201678 | wangtingyu@ihcams.ac.cn |
| Name | Affiliation | Role |
|---|---|---|
| Zengjun Li | Institute of Hematology & Blood Diseases Hospital Chinese Academy of Medical Sciences & Peking Union Medical College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Hematology & Blood Diseases Hospital Chinese Academy of Medical Sciences & Peking Union Medical College | Recruiting | Tianjin | Tianjin Municipality | 30020 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41497516 | Derived | Wang T, Yan Y, Wang H, Sun Y, Liu X, Lyu R, Xiong W, An G, Liu W, Xu Y, Deng S, Wang Q, Du C, Huang L, Zou D, Zhao Y, Qiu L, Li Z, Yi S. Ibrutinib alternating with three cycles of interval fludarabine, cyclophosphamide, and rituximab (FCR) in adults with untreated chronic lymphocytic leukaemia as time-limited regimen: a single-arm, multicentre phase 2 trial in China. EClinicalMedicine. 2025 Dec 5;90:103688. doi: 10.1016/j.eclinm.2025.103688. eCollection 2025 Dec. |
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|
| BR and Ibrutinib | Drug | Induction treatment: Patients ≥65y and ≤75 y or <65 y but with comorbidities, are given BR 1or 2 courses (If patients' white blood cell count drop to below10×10^9/Lafter first course, the second course can be saved). Then, patients takes ibrutinib orally for 3 months alternating with BR in 2 cylcles. 1.BR: B(Bendamustine):90mg/m2·d,d1-2; R(Rituximab):375mg/m2 d0(first course),500mg/m2 d0(subsequent courses); 2. Ibrutinib: 420mg/d |
|
| Ibrutinib and Thalidomide | Drug | Maintenance treatment: After induction treatment, recommend ( but not mandatory) Ibrutinib or thalidomide monotherapy(according to patients preferrance) for MRD-positive patients.For MRD-negative patients, recommend ( but not mandatory) no maintenance therapy. |
|
| PFS | Progression-free survival | 5 years |
| MRD negative rate | the rate of undetectable tumor cells in bone marrow and/or peripheral blood by multicolor flow cytometry | 3 months after completion of induction therapy |
| DoR | Duration of Response | 5 years |
| Treatment-related side effects | 10 months |
|
| ID | Term |
|---|---|
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| ID | Term |
|---|---|
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D011961 | Receptors, Fc |
| C551803 | ibrutinib |
| D013792 | Thalidomide |
| ID | Term |
|---|---|
| D011971 | Receptors, Immunologic |
| D011956 | Receptors, Cell Surface |
| D008565 | Membrane Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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