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

Sponsor

The First Affiliated Hospital with Nanjing Medical University (Other)

Overall Status

Unknown status

CT.gov ID

NCT01670812

Collaborator

(none)

100

Enrollment

Locations

Arm

Duration (Months)

7.1

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Lymphocytic Leukemia	Drug: FFP+HDMP+Rituximab	Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2012

Anticipated Primary Completion Date :

Jun 1, 2013

Anticipated Study Completion Date :

Jun 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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: fresh frozen plasma methylprednisolone rituximab

Arm

Intervention/Treatment

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:

fresh frozen plasma

methylprednisolone

rituximab

Outcome Measures

Primary Outcome Measures

overall response rate [one year]
overall response rate after treated by FFP+HDMP+Rituximab regimen

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The First affiliated Hospital of AnHui Medical Universtiy	Hefei	Anhui	China
2	TongJi Hospital	Wuhan	Hubei	China
3	ChangZhou First People's Hospital	ChangZhou	Jiangsu	China	213003
4	ChangZhou No.2 People's Hospital	ChangZhou	Jiangsu	China	213011
5	HuaiAn First People's Hospital	HuaiAn	Jiangsu	China	223300
6	NanJing First People's Hospital	NanJing	Jiangsu	China	210006
7	JiangSu Province Hospital	NanJing	Jiangsu	China	210029
8	JiangSu Province Hospital of TCM	Nanjing	Jiangsu	China
9	WuXi People's Hospital	WuXi	Jiangsu	China	214023
10	ZhenJiang First People's Hospital	ZhenJiang	Jiangsu	China	212002
11	Shandong Provincial Hospital	Jinan	Shandong	China
12	TongJi Medical University affiliated TongJi Hospital	Shanghai	Shanghai	China
13	West China School of Medicine, West China Hospital, Sichuan University	Chendu	Sichuan	China
14	Institute of Hematology & Blood Diseases Hospital	TianJin	Tianjin	China