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

Primary Purpose

Chronic Lymphocytic Leukemia

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
FFP+HDMP+Rituximab
Sponsored by
The First Affiliated Hospital with Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Lymphocytic Leukemia focused on measuring chronic lymphocytic leukemia, ultra-high risk, fresh frozen plasma, methylprednisolone, rituximab

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Aged 18-80 years old.
  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:

  1. Severe allergic constitution or asthma.
  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

Sites / Locations

  • The First affiliated Hospital of AnHui Medical UniverstiyRecruiting
  • TongJi HospitalRecruiting
  • ChangZhou First People's HospitalRecruiting
  • ChangZhou No.2 People's HospitalRecruiting
  • HuaiAn First People's HospitalRecruiting
  • NanJing First People's HospitalRecruiting
  • JiangSu Province HospitalRecruiting
  • JiangSu Province Hospital of TCMRecruiting
  • WuXi People's HospitalRecruiting
  • ZhenJiang First People's HospitalRecruiting
  • Shandong Provincial HospitalRecruiting
  • TongJi Medical University affiliated TongJi HospitalRecruiting
  • West China School of Medicine, West China Hospital, Sichuan UniversityRecruiting
  • Institute of Hematology & Blood Diseases HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

FFP+HDMP+Rituximab

Arm Description

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.

Outcomes

Primary Outcome Measures

overall response rate
overall response rate after treated by FFP+HDMP+Rituximab regimen

Secondary Outcome Measures

progression free survival
progression free survival after treatment of FFP+HDMP+Rituximab for ultra-high risk CLL patients.
overall survival
overall survival after treatment of FFP+HDMP+Rituximab for ultra-high risk CLL patients
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

Full Information

First Posted
August 19, 2012
Last Updated
August 19, 2012
Sponsor
The First Affiliated Hospital with Nanjing Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT01670812
Brief Title
Trial of FFP+HDMP+Rituximab for Ultra-high Risk Chronic Lymphocytic Leukemia
Official Title
Clinical Study of Chemoimmunotherapy With Fresh Frozen Plasma, High Dose Methylprednisolone and Rituximab for Ultra-high Risk Chronic Lymphocytic Leukemia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Unknown status
Study Start Date
January 2012 (undefined)
Primary Completion Date
June 2013 (Anticipated)
Study Completion Date
June 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The First Affiliated Hospital with Nanjing Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Lymphocytic Leukemia
Keywords
chronic lymphocytic leukemia, ultra-high risk, fresh frozen plasma, methylprednisolone, rituximab

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
FFP+HDMP+Rituximab
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
FFP+HDMP+Rituximab
Other Intervention Name(s)
fresh frozen plasma, methylprednisolone, rituximab
Intervention Description
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
Primary Outcome Measure Information:
Title
overall response rate
Description
overall response rate after treated by FFP+HDMP+Rituximab regimen
Time Frame
one year
Secondary Outcome Measure Information:
Title
progression free survival
Description
progression free survival after treatment of FFP+HDMP+Rituximab for ultra-high risk CLL patients.
Time Frame
one year
Title
overall survival
Description
overall survival after treatment of FFP+HDMP+Rituximab for ultra-high risk CLL patients
Time Frame
one year
Title
Number of Participants with Adverse Events
Description
Number of Participants with Adverse Events, and evaluated standard is according to common terminology criteria adverse events(CTCAE) version 4.0
Time Frame
up to 30 days after last dose of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
LEI FAN, M.D., Ph.D.
Phone
+86 25 6813 6034
Email
fanlei_fl@yahoo.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wei Xu, M.D., Ph.D.
Organizational Affiliation
The First Affiliated Hospital with Nanjing Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First affiliated Hospital of AnHui Medical Universtiy
City
Hefei
State/Province
Anhui
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zimin Sun, M.D., Ph.D.
Email
Zmsun_vip@163.com
First Name & Middle Initial & Last Name & Degree
Zimin Sun, M.D., Ph.D.
Facility Name
TongJi Hospital
City
Wuhan
State/Province
Hubei
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianfeng Zhou, M.D., Ph.D.
Email
zhougene@medmail.com.cn
First Name & Middle Initial & Last Name & Degree
Jianfeng Zhou, M.D., Ph.D.
Facility Name
ChangZhou First People's Hospital
City
ChangZhou
State/Province
Jiangsu
ZIP/Postal Code
213003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
XiangShan Cao, M.D., Ph.D.
First Name & Middle Initial & Last Name & Degree
XiangShan Cao, M.D., Ph.D.
Facility Name
ChangZhou No.2 People's Hospital
City
ChangZhou
State/Province
Jiangsu
ZIP/Postal Code
213011
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Min Zhou, Dr.
First Name & Middle Initial & Last Name & Degree
Min Zhou, M.D.
Facility Name
HuaiAn First People's Hospital
City
HuaiAn
State/Province
Jiangsu
ZIP/Postal Code
223300
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liang Yu, Dr.
First Name & Middle Initial & Last Name & Degree
Liang Yu, M.D., Ph.D.
Facility Name
NanJing First People's Hospital
City
NanJing
State/Province
Jiangsu
ZIP/Postal Code
210006
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
YanLi Xu, Dr.
First Name & Middle Initial & Last Name & Degree
YanLi Xu, M.D., Ph.D.
Facility Name
JiangSu Province Hospital
City
NanJing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
LEI FAN, Dr.
Phone
86 25 6813 6034
First Name & Middle Initial & Last Name & Degree
WEI XU, M.D., Ph.D.
Facility Name
JiangSu Province Hospital of TCM
City
Nanjing
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xuemei Sun, M.D., Ph.D.
First Name & Middle Initial & Last Name & Degree
Xuemei Sun, M.D., Ph.D.
Facility Name
WuXi People's Hospital
City
WuXi
State/Province
Jiangsu
ZIP/Postal Code
214023
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yun Zhuang, M.D.
First Name & Middle Initial & Last Name & Degree
YunFeng Shen, M.D., Ph.D.
Facility Name
ZhenJiang First People's Hospital
City
ZhenJiang
State/Province
Jiangsu
ZIP/Postal Code
212002
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yan Zhu, Dr.
First Name & Middle Initial & Last Name & Degree
Yan Zhu, M.D., Ph.D.
Facility Name
Shandong Provincial Hospital
City
Jinan
State/Province
Shandong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xin Wang, M.D., Ph.D.
First Name & Middle Initial & Last Name & Degree
Xin Wang, M.D., Ph.D.
Facility Name
TongJi Medical University affiliated TongJi Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aibin Liang, M.D., Ph.D.
First Name & Middle Initial & Last Name & Degree
Aibin Liang, M.D., Ph.D.
Facility Name
West China School of Medicine, West China Hospital, Sichuan University
City
Chendu
State/Province
Sichuan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ting Liu, M.D., Ph.D.
First Name & Middle Initial & Last Name & Degree
Ting Liu, M.D., Ph.D.
Facility Name
Institute of Hematology & Blood Diseases Hospital
City
TianJin
State/Province
Tianjin
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lugui Qiu, M.D., Ph.D.
Phone
+86 22 2390 9999
Email
drqiu99@medmail.com.cn
First Name & Middle Initial & Last Name & Degree
Lugui Qiu, M.D., Ph.D.

12. IPD Sharing Statement

Citations:
PubMed Identifier
20635386
Citation
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.
Results Reference
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PubMed Identifier
20627536
Citation
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.
Results Reference
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PubMed Identifier
18310545
Citation
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.
Results Reference
background
PubMed Identifier
19758239
Citation
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. Erratum In: Ann N Y Acad Sci. 2010 Aug;1204:198. Eliezer, Rachmilewitz [corrected to Rachmilewitz, Eliezer A]; Ami, Schattner [corrected to Schattner, Ami].
Results Reference
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Trial of FFP+HDMP+Rituximab for Ultra-high Risk Chronic Lymphocytic Leukemia

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