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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 76 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The First Affiliated Hospital with Nanjing Medical University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2012

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2013

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 19, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 19, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 22, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 22, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 19, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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