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The purpose of this study is to investigate efficacy and safety of fresh frozen plasma(FFP), high dose methylprednisolone(HDMP) and rituximab for ultra-high risk chronic lymphocytic leukemia.
Chronic lymphocytic leukemia remains incurable and particularly in ultra-high risk subgroup, and the prognosis of these patients is still dismal.
This is a phase III, multicenter perspective clinical trial of combination of fresh frozen plasma(FFP), high dose methylprednisolone(HDMP) and rituximab for ultra-high risk chronic lymphocytic leukemiaThe. The main purpose of this study is to investigate efficacy and safety of this combinated regimen in subgroup of CLL patients.
All the enrolled patients will be followed during and after the treatment period up to one year. Interim and final evaluation will be done after each cycle of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FFP+HDMP+Rituximab | Experimental | Fresh frozen plasma 400ml IV day0, Rituximab: 375 mg/m2 IV day0(after infusion of FFP), methylprednisolone 1g/m2(up to 1.5g) IV day1-day5. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FFP+HDMP+Rituximab | Drug | This is a single arm, multicenter clinical trial, and the regimen including Fresh frozen plasma 400ml IV day0, Rituximab: 375 mg/m2 IV day0(after infusion of FFP), methylprednisolone 1g/m2(up to 1.5g) IV day1-day5 |
| Measure | Description | Time Frame |
|---|---|---|
| overall response rate | overall response rate after treated by FFP+HDMP+Rituximab regimen | one year |
| Measure | Description | Time Frame |
|---|---|---|
| progression free survival | progression free survival after treatment of FFP+HDMP+Rituximab for ultra-high risk CLL patients. | one year |
| overall survival | overall survival after treatment of FFP+HDMP+Rituximab for ultra-high risk CLL patients |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| LEI FAN, M.D., Ph.D. | Contact | +86 25 6813 6034 | fanlei_fl@yahoo.com.cn |
| Name | Affiliation | Role |
|---|---|---|
| Wei Xu, M.D., Ph.D. | The First Affiliated Hospital with Nanjing Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First affiliated Hospital of AnHui Medical Universtiy | Recruiting | Hefei | Anhui | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20635386 | Background | Xu W, Miao KR, Zhu DX, Fang C, Zhu HY, Dong HJ, Wang DM, Wu YJ, Qiao C, Li JY. Enhancing the action of rituximab by adding fresh frozen plasma for the treatment of fludarabine refractory chronic lymphocytic leukemia. Int J Cancer. 2011 May 1;128(9):2192-201. doi: 10.1002/ijc.25560. | |
| 20627536 | Background | Xu W, Miao KR, Hong M, Zhu DX, Fang C, Dong HJ, Wang DM, Cao X, Li JY. High-dose methylprednisolone can induce remissions in patients with fludarabine-refractory chronic lymphocytic leukaemia. Eur J Cancer. 2010 Aug;46(12):2145-9. doi: 10.1016/j.ejca.2010.04.021. Epub 2010 Jun 4. |
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| ID | Term |
|---|---|
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| ID | Term |
|---|---|
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D008775 | Methylprednisolone |
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
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|
| one year |
| Number of Participants with Adverse Events | Number of Participants with Adverse Events, and evaluated standard is according to common terminology criteria adverse events(CTCAE) version 4.0 | up to 30 days after last dose of treatment |
| TongJi Hospital | Recruiting | Wuhan | Hubei | China |
|
| ChangZhou First People's Hospital | Recruiting | Changzhou | Jiangsu | 213003 | China |
|
| ChangZhou No.2 People's Hospital | Recruiting | Changzhou | Jiangsu | 213011 | China |
|
| HuaiAn First People's Hospital | Recruiting | HuaiAn | Jiangsu | 223300 | China |
|
| NanJing First People's Hospital | Recruiting | Nanjing | Jiangsu | 210006 | China |
|
| JiangSu Province Hospital | Recruiting | Nanjing | Jiangsu | 210029 | China |
|
| JiangSu Province Hospital of TCM | Recruiting | Nanjing | Jiangsu | China |
|
| WuXi People's Hospital | Recruiting | Wuxi | Jiangsu | 214023 | China |
|
| ZhenJiang First People's Hospital | Recruiting | Zhenjiang | Jiangsu | 212002 | China |
|
| Shandong Provincial Hospital | Recruiting | Jinan | Shandong | China |
|
| TongJi Medical University affiliated TongJi Hospital | Recruiting | Shanghai | Shanghai Municipality | China |
|
| West China School of Medicine, West China Hospital, Sichuan University | Recruiting | Chengdu | Sichuan | China |
|
| Institute of Hematology & Blood Diseases Hospital | Recruiting | Tianjin | Tianjin Municipality | China |
|
| 18310545 | Background | Dungarwalla M, Evans SO, Riley U, Catovsky D, Dearden CE, Matutes E. High dose methylprednisolone and rituximab is an effective therapy in advanced refractory chronic lymphocytic leukemia resistant to fludarabine therapy. Haematologica. 2008 Mar;93(3):475-6. doi: 10.3324/haematol.11903. |
| 19758239 | Background | Klepfish A, Gilles L, Ioannis K, Rachmilewitz EA, Schattner A. Enhancing the action of rituximab in chronic lymphocytic leukemia by adding fresh frozen plasma: complement/rituximab interactions & clinical results in refractory CLL. Ann N Y Acad Sci. 2009 Sep;1173:865-73. doi: 10.1111/j.1749-6632.2009.04803.x. |
| 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 |
| D013256 |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |