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

August 19, 2012 updated by: WEI XU, The First Affiliated Hospital with Nanjing Medical University

Clinical Study of Chemoimmunotherapy With Fresh Frozen Plasma, High Dose Methylprednisolone and Rituximab for Ultra-high Risk Chronic Lymphocytic Leukemia

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China
        • Recruiting
        • The First affiliated Hospital of AnHui Medical Universtiy
        • Contact:
        • Principal Investigator:
          • Zimin Sun, M.D., Ph.D.
    • Hubei
      • Wuhan, Hubei, China
        • Recruiting
        • Tongji Hospital
        • Contact:
        • Principal Investigator:
          • Jianfeng Zhou, M.D., Ph.D.
    • Jiangsu
      • ChangZhou, Jiangsu, China, 213003
        • Recruiting
        • Changzhou First People's Hospital
        • Contact:
          • XiangShan Cao, M.D., Ph.D.
        • Principal Investigator:
          • XiangShan Cao, M.D., Ph.D.
      • ChangZhou, Jiangsu, China, 213011
        • Recruiting
        • Changzhou No.2 People's Hospital
        • Contact:
          • Min Zhou, Dr.
        • Principal Investigator:
          • Min Zhou, M.D.
      • HuaiAn, Jiangsu, China, 223300
        • Recruiting
        • Huaian First People's Hospital
        • Contact:
          • Liang Yu, Dr.
        • Principal Investigator:
          • Liang Yu, M.D., Ph.D.
      • NanJing, Jiangsu, China, 210006
        • Recruiting
        • Nanjing First People's Hospital
        • Contact:
          • YanLi Xu, Dr.
        • Principal Investigator:
          • YanLi Xu, M.D., Ph.D.
      • NanJing, Jiangsu, China, 210029
        • Recruiting
        • Jiangsu Province Hospital
        • Contact:
          • LEI FAN, Dr.
          • Phone Number: 86 25 6813 6034
        • Principal Investigator:
          • Wei Xu, M.D., Ph.D.
      • Nanjing, Jiangsu, China
        • Recruiting
        • Jiangsu Province Hospital of TCM
        • Contact:
          • Xuemei Sun, M.D., Ph.D.
        • Principal Investigator:
          • Xuemei Sun, M.D., Ph.D.
      • WuXi, Jiangsu, China, 214023
        • Recruiting
        • Wuxi People's Hospital
        • Contact:
          • Yun Zhuang, M.D.
        • Principal Investigator:
          • YunFeng Shen, M.D., Ph.D.
      • ZhenJiang, Jiangsu, China, 212002
        • Recruiting
        • Zhenjiang First People's Hospital
        • Contact:
          • Yan Zhu, Dr.
        • Principal Investigator:
          • Yan Zhu, M.D., Ph.D.
    • Shandong
      • Jinan, Shandong, China
        • Recruiting
        • Shandong Provincial Hospital
        • Principal Investigator:
          • Xin Wang, M.D., Ph.D.
        • Contact:
          • Xin Wang, M.D., Ph.D.
    • Shanghai
      • Shanghai, Shanghai, China
        • Recruiting
        • TongJi Medical University affiliated TongJi Hospital
        • Contact:
          • Aibin Liang, M.D., Ph.D.
        • Principal Investigator:
          • Aibin Liang, M.D., Ph.D.
    • Sichuan
      • Chendu, Sichuan, China
        • Recruiting
        • West China School of Medicine, West China Hospital, Sichuan University
        • Contact:
          • Ting Liu, M.D., Ph.D.
        • Principal Investigator:
          • Ting Liu, M.D., Ph.D.
    • Tianjin
      • TianJin, Tianjin, China
        • Recruiting
        • Institute of Hematology & Blood Diseases Hospital
        • Contact:
        • Principal Investigator:
          • Lugui Qiu, M.D., Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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:
  • methylprednisolone
  • rituximab
  • fresh frozen plasma

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall response rate
Time Frame: one year
overall response rate after treated by FFP+HDMP+Rituximab regimen
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with Adverse Events
Time Frame: up to 30 days after last dose of treatment
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
progression free survival
Time Frame: one year
progression free survival after treatment of FFP+HDMP+Rituximab for ultra-high risk CLL patients.
one year
overall survival
Time Frame: one year
overall survival after treatment of FFP+HDMP+Rituximab for ultra-high risk CLL patients
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Investigators

  • Principal Investigator: Wei Xu, M.D., Ph.D., The First Affiliated Hospital with Nanjing Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Anticipated)

June 1, 2013

Study Completion (Anticipated)

June 1, 2014

Study Registration Dates

First Submitted

August 19, 2012

First Submitted That Met QC Criteria

August 19, 2012

First Posted (Estimate)

August 22, 2012

Study Record Updates

Last Update Posted (Estimate)

August 22, 2012

Last Update Submitted That Met QC Criteria

August 19, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JSPH-CLL-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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