Condition or disease | Intervention/treatment | Phase |
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Chronic Lymphocytic Leukemia | Drug: FCR and Ibrutinib Drug: BR and Ibrutinib Drug: Ibrutinib and Thalidomide | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 50 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Prospective Multicenter Phase 2 Study of FCR/BR Alternating With Ibrutinib in Treatment-naive Patients With Chronic Lymphocytic Leukemia |
Actual Study Start Date : | May 15, 2019 |
Estimated Primary Completion Date : | December 15, 2022 |
Estimated Study Completion Date : | December 30, 2027 |
Arm | Intervention/treatment |
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Experimental: FCR/BR alternating with ibrutinib
FCR/BR→ ibrutinib✖️3months→FCR/BR→ ibrutinib✖️3months→FCR/BR→Maintenance therapy
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Drug: FCR and Ibrutinib
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.
Drug: BR and Ibrutinib 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 Drug: Ibrutinib and Thalidomide 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. |
Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion 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)
Exclusion Criteria:
Contact: Zengjun Li | +86 13642138692 | lizengjun@ihcams.ac.cn | |
Contact: Tingyu Wang | +86 15692201678 | wangtingyu@ihcams.ac.cn |
China, Tianjin | |
Institute of Hematology & Blood Diseases Hospital Chinese Academy of Medical Sciences & Peking Union Medical College | Recruiting |
Tianjin, Tianjin, China, 30020 | |
Contact: Zengjun Li +86 13642138692 lizengjun@ihcams.ac.cn | |
Contact: Tingyu Wang +86 15692201678 wangtingyu@ihcams.ac.cn | |
Principal Investigator: Zengjun Li | |
Sub-Investigator: Tingyu Wang |
Principal Investigator: | Zengjun Li | Institute of Hematology & Blood Diseases Hospital Chinese Academy of Medical Sciences & Peking Union Medical College |
Tracking Information | |||||||||
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First Submitted Date ICMJE | June 6, 2019 | ||||||||
First Posted Date ICMJE | June 10, 2019 | ||||||||
Last Update Posted Date | June 10, 2019 | ||||||||
Actual Study Start Date ICMJE | May 15, 2019 | ||||||||
Estimated Primary Completion Date | December 15, 2022 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
CRR [ Time Frame: 3 months after completion of induction therapy ] Rate of complete remission
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | No Changes Posted | ||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | A Prospective Multicenter Phase 2 Study of FCR/BR Alternating With Ibrutinib in Treatment-naive Patients With CLL | ||||||||
Official Title ICMJE | A Prospective Multicenter Phase 2 Study of FCR/BR Alternating With Ibrutinib in Treatment-naive Patients With Chronic Lymphocytic Leukemia | ||||||||
Brief Summary | 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. | ||||||||
Detailed Description | Not Provided | ||||||||
Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Phase 2 | ||||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Chronic Lymphocytic Leukemia | ||||||||
Intervention ICMJE |
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Study Arms ICMJE | Experimental: FCR/BR alternating with ibrutinib
FCR/BR→ ibrutinib✖️3months→FCR/BR→ ibrutinib✖️3months→FCR/BR→Maintenance therapy
Interventions:
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
50 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | December 30, 2027 | ||||||||
Estimated Primary Completion Date | December 15, 2022 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 75 Years (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | China | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT03980002 | ||||||||
Other Study ID Numbers ICMJE | IHBDH-IIT2018009 | ||||||||
Has Data Monitoring Committee | No | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | TingyuWang, Institute of Hematology & Blood Diseases Hospital | ||||||||
Study Sponsor ICMJE | Institute of Hematology & Blood Diseases Hospital | ||||||||
Collaborators ICMJE | Not Provided | ||||||||
Investigators ICMJE |
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PRS Account | Institute of Hematology & Blood Diseases Hospital | ||||||||
Verification Date | June 2019 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |