Newly Diagnosed Waldenström's Macroglobulinemia
Sponsor:
Kosin University Gospel Hospital
Collaborators:
Information provided by (Responsible Party):
Ho Sup Lee，Kosin University Gospel Hospital
| Tracking Information | |||
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| First Submitted Date ICMJE | October 1, 2018 | ||
| First Posted Date ICMJE | October 5, 2018 | ||
| Last Update Posted Date | October 5, 2018 | ||
| Actual Study Start Date ICMJE | October 1, 2018 | ||
| Estimated Primary Completion Date | October 31, 2021 (Final data collection date for primary outcome measure) | ||
| Current Primary Outcome Measures ICMJE |
survival[ Time Frame: 2 years ] Response assessment in Waldenström macroglobulinaemia |
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| Original Primary Outcome Measures ICMJE | Same as current | ||
| Current Secondary Outcome Measures ICMJE |
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| Descriptive Information | |||
| Brief Title ICMJE | Newly Diagnosed Waldenström's Macroglobulinemia |
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| Official Title ICMJE | A Multicenter Prospective Phase II Study of Rituximab Combined, Lenalidomide, Dexamethasone Followed by Lenalidomide Maintenance in Patients With Newly Diagnosed Waldenström's Macroglobulinemia |
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| Brief Summary | A multicenter prospective phase II study of rituximab combined, lenalidomide, dexamethasone followed by lenalidomide maintenance in patients with newly diagnosed Waldenström's macroglobulinemia (Ballondor trial) |
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| Detailed Description | Most patients with Waldenstrom's Macroglobulinemia are rare, and most studies are based on Phase II clinical studies, so the most effective regimen has not been established. However, in patients without experience of treatment with rituximab monotherapy targeting CD20 antigen expressed on lymphocytic cells, the response rate is reported to be approximately 25% -45%. Combined chemotherapy including rituximab is recommended as a primary treatment. In Korea, there are few studies on Waldenstrom's Macroglobulinemia, and a relatively large number of patients have studied the data of 71 patients in 2014, retrospectively. In the present study, we found that the combined chemotherapy regimen with rituximab significantly improved the overall response rates. Bortezomib may also be effective in the treatment of Waldenstrom's Macroglobulinemia. Based on this, clinical trials of combined chemotherapy with rituximab or dexamethasone have been conducted and 80-90% reported However, lenalidomide 15mg alone was administered, lenalidomide was effective in Waldenstrom's Macroglobulinemia with a 29% overall response rate. The authors concluded that the combination therapy of rituximab, bortezomib, lenalidomide, and dexamethasone is an effective treatment regimen that can improve the overall response rate including complete remission. Patients with Waldenstrom's Macroglobulinemia diagnosed in Korea we planned this study to evaluate the efficacy and safety of lenalidomide maintenance therapy with chemotherapy with chemotherapy including rituximab, bortezomib, lenalidomide, and dexamethasone | ||
| Study Type ICMJE | Interventional | ||
| Study Phase | Phase 2 | ||
| Study Design ICMJE | Allocation: Intervention Model: Single Group Assignment Intervention Model Description: Masking: Interventional Masking Description: Primary Purpose: Treatment |
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| Condition ICMJE | |||
| Intervention ICMJE |
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| Study Arms |
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| Recruitment Information | |||
| Recruitment Status ICMJE | Not yet recruiting | ||
| Estimated Enrollment ICMJE |
54 | ||
| Original Estimated Enrollment ICMJE | Same as current | ||
| Estimated Study Completion Date | October 31, 2023 | ||
| Estimated Primary Completion Date | October 31, 2021 (Final data collection date for primary outcome measure) | ||
| Eligibility Criteria ICMJE | Inclusion Criteria: 1. Clinicopathological diagnosis of Waldenstrom's Macroglobulinemia 2. Patients who meet criteria for treatment using consensus panel criteria from the Second International Workshop on Waldenstrom's macroglobulinemia 3. Male or female patients aged ≥19 years 4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2 5. Patients must have measurable disease, IgM > 0.5g/dL 6. Appropriate bone marrow, liver, and kidney function 7. Patients who are able to understand oral and written instructions and who are able to comply with all requirements 8. Patients who provided agreement of subject consent (ICF) prior to initiation of clinical trial. 9. Female patients had to be post-menopausal for ≥1 year, surgically sterile, or practicing an effective method of birth control (as described in the protocol), and have a negative serum beta-human chorionic gonadotropin or urine pregnancy test at screening; they also had to agree to continue using birth control measures for ≥6 months after terminating treatment. Male patients had to agree to use an acceptable method of contraception for the duration of the study. Exclusion Criteria: 1. Central nervous system involvement central nervous system (CNS) involvement by Waldenström's macroglobulinemia 2. Patients who have received rituximab, lenalidomide, or bortezomib 3. Patients who are allergic or hypersensitive to mouse (murine), chimeric, human or humanized proteins, lenalidomide, bortezomib 4. One of the following labs or more: - Absolute neutrophil count (ANC) <1,000 / μL - Platelet count <75,000 cells / μL when not transfused - Serum AST / ALT> 3 times the upper limit of normal 5. Renal failure requiring hemodialysis or peritoneal dialysis 6. Patients with uncontrolled severe heart disease 7. Patients who can not or do not want antithrombotic therapy 8. Patient has more than Grade 2 peripheral neuropathy on clinical examination during the screening period 9. Patient with a history of stroke or cerebral hemorrhage within 12 months bofore signing ICF 10. Patients who have been diagnosed with a currently unadjusted severe infection 11. Patients with known human immunodeficiency virus (HIV), hepatitis C infection 12. Patients diagnosed with malignancy within 5 years before signing ICF 13. Pregnant or lactating patients 14. Requires treatment with a strong cytochrome P450 (CYP) 3A inhibitor 15. Patients with acute diffuse invasive pulmonary disease and cardiovascular disease | ||
| Sex/Gender |
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| Ages | 19 Years and older (Adult, Older Adult) | ||
| Accepts Healthy Volunteers | No | ||
| Listed Location Countries ICMJE | |||
| Removed Location Countries | |||
| Administrative Information | Has Data Monitoring Committee | No | |
| U.S. FDA-regulated Product |
Studies a U.S. FDA-regulated Drug Product: No Studies a U.S. FDA-regulated Device Product: No |
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| IPD Sharing Statement |
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| Responsible Party | Ho Sup Lee，Kosin University Gospel Hospital | ||
| Study Sponsor ICMJE | Kosin University Gospel Hospital | ||
| Collaborators ICMJE | |||
| Investigators ICMJE |
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| PRS Account | Kosin University Gospel Hospital | ||
| Verification Date | October 2018 | ||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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