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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Chronic Lymphocytic Leukemia

Intervention / Treatment
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* Drug: FFP+HDMP+Rituximab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FFP+HDMP+Rituximab<br>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<br>* 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<br>* Other names: rituximab;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic lymphocytic leukemia, ultra-high risk, fresh frozen plasma, methylprednisolone, rituximab