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

NCT01670812 | Unknown Phase 3 DMC

• 1 other identifier: JSPH-CLL-001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 14

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.

Conditions

Chronic Lymphocytic Leukemia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• overall response rate

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

  one year

Secondary Outcomes (3)

• progression free survival

  one year

• overall survival

  one year

• Number of Participants with Adverse Events

  up to 30 days after last dose of treatment

Study Arms (1)

FFP+HDMP+Rituximab

EXPERIMENTAL

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

Interventions

FFP+HDMP+Rituximab DRUG

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

Also known as: fresh frozen plasma, methylprednisolone, rituximab

FFP+HDMP+Rituximab

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (14)

The First affiliated Hospital of AnHui Medical Universtiy

Hefei, Anhui, China

RECRUITING

TongJi Hospital

Wuhan, Hubei, China

RECRUITING

ChangZhou First People's Hospital

Changzhou, Jiangsu, 213003, China

RECRUITING

ChangZhou No.2 People's Hospital

Changzhou, Jiangsu, 213011, China

RECRUITING

HuaiAn First People's Hospital

HuaiAn, Jiangsu, 223300, China

RECRUITING

NanJing First People's Hospital

Nanjing, Jiangsu, 210006, China

RECRUITING

JiangSu Province Hospital

Nanjing, Jiangsu, 210029, China

RECRUITING

JiangSu Province Hospital of TCM

Nanjing, Jiangsu, China

RECRUITING

WuXi People's Hospital

Wuxi, Jiangsu, 214023, China

RECRUITING

ZhenJiang First People's Hospital

Zhenjiang, Jiangsu, 212002, China

RECRUITING

Shandong Provincial Hospital

Jinan, Shandong, China

RECRUITING

TongJi Medical University affiliated TongJi Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

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

Chengdu, Sichuan, China

RECRUITING

Institute of Hematology & Blood Diseases Hospital

Tianjin, Tianjin Municipality, China

RECRUITING

Related Publications (4)

• 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.

  PMID: 20635386 BACKGROUND

• 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.

  PMID: 20627536 BACKGROUND

• 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.

  PMID: 18310545 BACKGROUND

• 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.

  PMID: 19758239 BACKGROUND

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

Methylprednisolone; Rituximab

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Wei Xu, M.D., Ph.D.

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

+86 25 6813 6034; fanlei_fl@yahoo.com.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 19, 2012
• First Posted: August 22, 2012
• Study Start: January 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2014
• Last Updated: August 22, 2012

Record last verified: 2012-08

Locations

CN (14)