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Chronic Lymphocytic LeukemiaPhase 3NCT01670812

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

A Phase 3 study testing FFP+HDMP+Rituximab in people with Chronic Lymphocytic Leukemia, run by The First Affiliated Hospital with Nanjing Medical University at 14 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Chronic Lymphocytic Leukemia
What is being tested?
FFP+HDMP+Rituximab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
14 sitesChina
Study dates
Jan 2012to Jun 2014
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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).
Show all 12Show fewer
  • 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

Trial locations and contacts

14 sites in 1 country.

LEI FAN, M.D., Ph.D. contact

+86 25 6813 6034

fanlei_fl@yahoo.com.cn

14 sites in 1 country

China14 sites, 14 recruiting

  • ChangZhou First People's Hospital

    Changzhou, Jiangsu, 213003

    XiangShan Cao, M.D., Ph.D.

    XiangShan Cao, M.D., Ph.D.

    Recruiting

  • ChangZhou No.2 People's Hospital

    Changzhou, Jiangsu, 213011

    Min Zhou, Dr.

    Min Zhou, M.D.

    Recruiting

  • West China School of Medicine, West China Hospital, Sichuan University

    Chengdu, Sichuan

    Ting Liu, M.D., Ph.D.

    Ting Liu, M.D., Ph.D.

    Recruiting

  • The First affiliated Hospital of AnHui Medical Universtiy

    Hefei, Anhui

    Zimin Sun, M.D., Ph.D., Zmsun_vip@163.com

    Zimin Sun, M.D., Ph.D.

    Recruiting

  • HuaiAn First People's Hospital

    HuaiAn, Jiangsu, 223300

    Liang Yu, Dr.

    Liang Yu, M.D., Ph.D.

    Recruiting

  • Shandong Provincial Hospital

    Jinan, Shandong

    Xin Wang, M.D., Ph.D.

    Xin Wang, M.D., Ph.D.

    Recruiting

  • NanJing First People's Hospital

    Nanjing, Jiangsu, 210006

    YanLi Xu, Dr.

    YanLi Xu, M.D., Ph.D.

    Recruiting

  • JiangSu Province Hospital

    Nanjing, Jiangsu, 210029

    LEI FAN, Dr., 86 25 6813 6034

    WEI XU, M.D., Ph.D.

    Recruiting

  • JiangSu Province Hospital of TCM

    Nanjing, Jiangsu

    Xuemei Sun, M.D., Ph.D.

    Xuemei Sun, M.D., Ph.D.

    Recruiting

  • TongJi Medical University affiliated TongJi Hospital

    Shanghai, Shanghai Municipality

    Aibin Liang, M.D., Ph.D.

    Aibin Liang, M.D., Ph.D.

    Recruiting

  • Institute of Hematology & Blood Diseases Hospital

    Tianjin, Tianjin Municipality

    Lugui Qiu, M.D., Ph.D., +86 22 2390 9999, drqiu99@medmail.com.cn

    Lugui Qiu, M.D., Ph.D.

    Recruiting

  • TongJi Hospital

    Wuhan, Hubei

    Jianfeng Zhou, M.D., Ph.D., zhougene@medmail.com.cn

    Jianfeng Zhou, M.D., Ph.D.

    Recruiting

  • WuXi People's Hospital

    Wuxi, Jiangsu, 214023

    Yun Zhuang, M.D.

    YunFeng Shen, M.D., Ph.D.

    Recruiting

  • ZhenJiang First People's Hospital

    Zhenjiang, Jiangsu, 212002

    Yan Zhu, Dr.

    Yan Zhu, M.D., Ph.D.

    Recruiting

Other trials in China

About this study

Official title: 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.

Read the 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.

Being tested
FFP+HDMP+Rituximab
Keywords
chronic lymphocytic leukemia, ultra-high risk, fresh frozen plasma, methylprednisolone, rituximab
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FFP+HDMP+RituximabDrug

    Also called fresh frozen plasma, methylprednisolone, 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

Study groups in NCT01670812
Study groupRoleWhat they receive
FFP+HDMP+RituximabExperimentalFresh 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.
Receives: Drug: FFP+HDMP+Rituximab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. overall response rate

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

    Measured: one year

Secondary outcomes (3)

  1. progression free survival

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

    Measured: one year

  2. overall survival

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

    Measured: one year

  3. 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

    Measured: up to 30 days after last dose of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Aug 2012 (estimated)
  2. Study startJan 2012
  3. Primary completionJun 2013 (estimated)
  4. Study completionJun 2014 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01670812
Sponsor's protocol ID
JSPH-CLL-001
Status last verified
Aug 2012
First submitted
19 Aug 2012
Last updated
22 Aug 2012
Results posted
No
Data monitoring committee
Yes

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.

    PubMed 20635386

  • 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.

    PubMed 20627536

  • 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.

    PubMed 18310545

  • 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.

    PubMed 19758239

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing FFP+HDMP+Rituximab in people with Chronic Lymphocytic Leukemia, run by The First Affiliated Hospital with Nanjing Medical University at 14 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact LEI FAN, M.D., Ph.D. (+86 25 6813 6034, fanlei_fl@yahoo.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

overall response rate (time frame: one year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01670812, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2012.

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