Trial of FFP+HDMP+Rituximab for Ultra-high Risk Chronic Lymphocytic Leukemia
NCT ID: NCT01670812
Last Updated: 2012-08-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
100 participants
INTERVENTIONAL
2012-01-31
2014-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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FFP+HDMP+Rituximab
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.
FFP+HDMP+Rituximab
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
Interventions
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FFP+HDMP+Rituximab
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Diagnosis of chronic lymphocytic leukemia.
3. Active disease meeting at least one of the International Workshop on Chronic Lymphocytic Leukemia 2008 criteria for requiring treatment.
4. Ultra-high risk CLL(Meets at least one of the following criteria) (1)ultra high-risk genetics (17p deletion and/or TP53 mutation) (2)short PFS(\<24 months)after intense immunochemotherapy treatment(i.e. FCR, FR, PCR, BR etc) (3)fludarabine-refractory
5. Understand and voluntarily sign an informed consent form, able to adhere to the study visit schedule and other protocol requirements
Exclusion Criteria
2. Recent myocardial infarction or hypotension.
3. ECOG performance status of ≤ 2 at study entry.
4. Active hepatitis B(DNA \>1×103/ml)
5. Severe and uncontrolled diabetes mellitus.
6. Severe and uncontrolled hypertension(BP\> 150/90 mmHg after treatment).
7. Active and uncontrolled systematic infection which need treatment of antibiotics.
8. Clinical symptoms of dysfunction of central nervous system.
9. Unstable and severe gastrorrhagia and peptic ulcer.
10. Major surgery within three weeks.
11. Any potential drug abuse, medical, psychological or social conditions which may disturb this investigation and assessment.
12. In any conditions which investigator considered ineligible for this study
18 Years
80 Years
ALL
No
Sponsors
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The First Affiliated Hospital with Nanjing Medical University
OTHER
Responsible Party
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WEI XU
Professor
Principal Investigators
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Wei Xu, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital with Nanjing Medical University
Locations
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The First affiliated Hospital of AnHui Medical Universtiy
Hefei, Anhui, China
TongJi Hospital
Wuhan, Hubei, China
ChangZhou First People's Hospital
Changzhou, Jiangsu, China
ChangZhou No.2 People's Hospital
Changzhou, Jiangsu, China
HuaiAn First People's Hospital
HuaiAn, Jiangsu, China
NanJing First People's Hospital
Nanjing, Jiangsu, China
JiangSu Province Hospital
Nanjing, Jiangsu, China
JiangSu Province Hospital of TCM
Nanjing, Jiangsu, China
WuXi People's Hospital
Wuxi, Jiangsu, China
ZhenJiang First People's Hospital
Zhenjiang, Jiangsu, China
Shandong Provincial Hospital
Jinan, Shandong, China
TongJi Medical University affiliated TongJi Hospital
Shanghai, Shanghai Municipality, China
West China School of Medicine, West China Hospital, Sichuan University
Chengdu, Sichuan, China
Institute of Hematology & Blood Diseases Hospital
Tianjin, Tianjin Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Zimin Sun, M.D., Ph.D.
Role: primary
Jianfeng Zhou, M.D., Ph.D.
Role: primary
XiangShan Cao, M.D., Ph.D.
Role: primary
Min Zhou, Dr.
Role: primary
Liang Yu, Dr.
Role: primary
YanLi Xu, Dr.
Role: primary
LEI FAN, Dr.
Role: primary
Xuemei Sun, M.D., Ph.D.
Role: primary
Yun Zhuang, M.D.
Role: primary
Yan Zhu, Dr.
Role: primary
Xin Wang, M.D., Ph.D.
Role: primary
Aibin Liang, M.D., Ph.D.
Role: primary
Ting Liu, M.D., Ph.D.
Role: primary
Lugui Qiu, M.D., Ph.D.
Role: primary
References
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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.
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.
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.
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.
Other Identifiers
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JSPH-CLL-001
Identifier Type: -
Identifier Source: org_study_id