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

Phase 3

• Conditions: Chronic Lymphocytic Leukemia
• Interventions: Drug: FFP+HDMP+Rituximab

• Registration Number: NCT01670812
• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

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.

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 Timeline

• Study Start: 2012-01
• Status Verified: 2012-08
• Study First Submitted: 2012-08-19
• Study First Submitted QC: 2012-08-19
• Last Update Submitted: 2012-08-19
• Study First Posted: 2012-08-22
• Last Update Posted: 2012-08-22
• Primary Completion: 2013-06
• Study Completion: 2014-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FFP+HDMP+Rituximab	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.

Primary Outcome Measures

Name	Time	Method
overall response rate	one year	overall response rate after treated by FFP+HDMP+Rituximab regimen

Secondary Outcome Measures

Name	Time	Method
progression free survival	one year	progression free survival after treatment of FFP+HDMP+Rituximab for ultra-high risk CLL patients.
overall survival	one year	overall survival after treatment of FFP+HDMP+Rituximab for ultra-high risk CLL patients
Number of Participants with Adverse Events	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

Trial Locations

Locations (14)

The First affiliated Hospital of AnHui Medical Universtiy; 🇨🇳 Hefei, Anhui, China

TongJi Hospital; 🇨🇳 Wuhan, Hubei, China

ChangZhou First People's Hospital; 🇨🇳 ChangZhou, Jiangsu, China

ChangZhou No.2 People's Hospital; 🇨🇳 ChangZhou, Jiangsu, China

HuaiAn First People's Hospital; 🇨🇳 HuaiAn, Jiangsu, China

NanJing First People's Hospital; 🇨🇳 NanJing, Jiangsu, China

JiangSu Province Hospital; 🇨🇳 NanJing, Jiangsu, China

JiangSu Province Hospital of TCM; 🇨🇳 Nanjing, Jiangsu, China

WuXi People's Hospital; 🇨🇳 WuXi, Jiangsu, China

ZhenJiang First People's Hospital; 🇨🇳 ZhenJiang, Jiangsu, China

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