Trial of FFP+HDMP+Rituximab for Ultra-high Risk Chronic Lymphocytic Leukemia - Full Text View

Purpose

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.

Condition	Intervention	Phase
Chronic Lymphocytic Leukemia	Drug: FFP+HDMP+Rituximab	Phase 3

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Clinical Study of Chemoimmunotherapy With Fresh Frozen Plasma, High Dose Methylprednisolone and Rituximab for Ultra-high Risk Chronic Lymphocytic Leukemia

Resource links provided by NLM:

MedlinePlus related topics: Chronic Lymphocytic Leukemia Leukemia

Drug Information available for: Prednisolone Prednisolone acetate Methylprednisolone acetate Methylprednisolone Prednisolone sodium phosphate Prednisolone phosphate Prednisolone sodium succinate Methylprednisolone sodium succinate Rituximab

U.S. FDA Resources

Further study details as provided by Jiangsu Province Hospital:

Primary Outcome Measures:

overall response rate [ Time Frame: one year ] [ Designated as safety issue: No ]
overall response rate after treated by FFP+HDMP+Rituximab regimen

Secondary Outcome Measures:

progression free survival [ Time Frame: one year ] [ Designated as safety issue: No ]
progression free survival after treatment of FFP+HDMP+Rituximab for ultra-high risk CLL patients.
overall survival [ Time Frame: one year ] [ Designated as safety issue: No ]
overall survival after treatment of FFP+HDMP+Rituximab for ultra-high risk CLL patients
Number of Participants with Adverse Events [ Time Frame: up to 30 days after last dose of treatment ] [ Designated as safety issue: Yes ]
Number of Participants with Adverse Events, and evaluated standard is according to common terminology criteria adverse events(CTCAE) version 4.0

Estimated Enrollment:	100
Study Start Date:	January 2012
Estimated Study Completion Date:	June 2014
Estimated Primary Completion Date:	June 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 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.	Drug: 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 Names: fresh frozen plasma methylprednisolone rituximab

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Aged 18-80 years old.
Diagnosis of chronic lymphocytic leukemia.
Active disease meeting at least one of the International Workshop on Chronic Lymphocytic Leukemia 2008 criteria for requiring treatment.
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
Understand and voluntarily sign an informed consent form, able to adhere to the study visit schedule and other protocol requirements

Exclusion Criteria:

Severe allergic constitution or asthma.
Recent myocardial infarction or hypotension.
ECOG performance status of ≤ 2 at study entry.
Active hepatitis B(DNA >1×103/ml)
Severe and uncontrolled diabetes mellitus.
Severe and uncontrolled hypertension(BP> 150/90 mmHg after treatment).
Active and uncontrolled systematic infection which need treatment of antibiotics.
Clinical symptoms of dysfunction of central nervous system.
Unstable and severe gastrorrhagia and peptic ulcer.
Major surgery within three weeks.
Any potential drug abuse, medical, psychological or social conditions which may disturb this investigation and assessment.
In any conditions which investigator considered ineligible for this study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01670812

Contacts

Contact: LEI FAN, M.D., Ph.D.

+86 25 6813 6034

fanlei_fl@yahoo.com.cn

Locations

China, Anhui
The First affiliated Hospital of AnHui Medical Universtiy	Recruiting
Hefei, Anhui, China
Contact: Zimin Sun, M.D., Ph.D. Zmsun_vip@163.com
Principal Investigator: Zimin Sun, M.D., Ph.D.
China, Hubei
TongJi Hospital	Recruiting
Wuhan, Hubei, China
Contact: Jianfeng Zhou, M.D., Ph.D. zhougene@medmail.com.cn
Principal Investigator: Jianfeng Zhou, M.D., Ph.D.
China, Jiangsu
ChangZhou First People's Hospital	Recruiting
ChangZhou, Jiangsu, China, 213003
Contact: XiangShan Cao, M.D., Ph.D.
Principal Investigator: XiangShan Cao, M.D., Ph.D.
ChangZhou No.2 People's Hospital	Recruiting
ChangZhou, Jiangsu, China, 213011
Contact: Min Zhou, Dr.
Principal Investigator: Min Zhou, M.D.
HuaiAn First People's Hospital	Recruiting
HuaiAn, Jiangsu, China, 223300
Contact: Liang Yu, Dr.
Principal Investigator: Liang Yu, M.D., Ph.D.
JiangSu Province Hospital	Recruiting
NanJing, Jiangsu, China, 210029
Contact: LEI FAN, Dr. 86 25 6813 6034
Principal Investigator: WEI XU, M.D., Ph.D.
NanJing First People's Hospital	Recruiting
NanJing, Jiangsu, China, 210006
Contact: YanLi Xu, Dr.
Principal Investigator: YanLi Xu, M.D., Ph.D.
JiangSu Province Hospital of TCM	Recruiting
Nanjing, Jiangsu, China
Contact: Xuemei Sun, M.D., Ph.D.
Principal Investigator: Xuemei Sun, M.D., Ph.D.
WuXi People's Hospital	Recruiting
WuXi, Jiangsu, China, 214023
Contact: Yun Zhuang, M.D.
Principal Investigator: YunFeng Shen, M.D., Ph.D.
ZhenJiang First People's Hospital	Recruiting
ZhenJiang, Jiangsu, China, 212002
Contact: Yan Zhu, Dr.
Principal Investigator: Yan Zhu, M.D., Ph.D.
China, Shandong
Shandong Provincial Hospital	Recruiting
Jinan, Shandong, China
Contact: Xin Wang, M.D., Ph.D.
Principal Investigator: Xin Wang, M.D., Ph.D.
China, Shanghai
TongJi Medical University affiliated TongJi Hospital	Recruiting
Shanghai, Shanghai, China
Contact: Aibin Liang, M.D., Ph.D.
Principal Investigator: Aibin Liang, M.D., Ph.D.
China, Sichuan
West China School of Medicine, West China Hospital, Sichuan University	Recruiting
Chendu, Sichuan, China
Contact: Ting Liu, M.D., Ph.D.
Principal Investigator: Ting Liu, M.D., Ph.D.
China, Tianjin
Institute of Hematology & Blood Diseases Hospital	Recruiting
TianJin, Tianjin, China
Contact: Lugui Qiu, M.D., Ph.D. +86 22 2390 9999 drqiu99@medmail.com.cn
Principal Investigator: Lugui Qiu, M.D., Ph.D.

Sponsors and Collaborators

Jiangsu Province Hospital

Investigators

Principal Investigator:

Wei Xu, M.D., Ph.D.

Jiangsu Province Hospital

More Information

Publications:

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. 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.

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. Erratum in: Ann N Y Acad Sci. 2010 Aug;1204:198. Eliezer, Rachmilewitz [corrected to Rachmilewitz, Eliezer A]; Ami, Schattner [corrected to Schattner, Ami].

Responsible Party:	WEI XU, Professor, Jiangsu Province Hospital
ClinicalTrials.gov Identifier:	NCT01670812 History of Changes
Other Study ID Numbers:	JSPH-CLL-001
Study First Received:	August 19, 2012
Last Updated:	August 19, 2012
Health Authority:	China: Ministry of Health

Keywords provided by Jiangsu Province Hospital:

chronic lymphocytic leukemia
ultra-high risk
fresh frozen plasma
methylprednisolone
rituximab

Additional relevant MeSH terms:

Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Methylprednisolone acetate
Prednisolone acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone

Prednisolone hemisuccinate
Prednisolone phosphate
Rituximab
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents
Glucocorticoids

ClinicalTrials.gov processed this record on June 18, 2013