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

Sponsor
The First Affiliated Hospital with Nanjing Medical University
Study ID
NCT01670812
Phase
PHASE3
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

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

Study Details

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.

Key Dates

Start date
Jan 31, 2012
Status verified
Aug 2012
Primary completion
Jun 30, 2013
Completion
Jun 30, 2014

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

overall response rate [ Time Frame: one year ]

Central Contacts

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