Chronic Lymphocytic Leukemia
Conditions
Keywords
chronic lymphocytic leukemia, ultra-high risk, fresh frozen plasma, methylprednisolone, rituximab
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.
Interventions
DRUGFFP+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
Sponsors
The First Affiliated Hospital with Nanjing Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| overall response rate | one year | overall response rate after treated by FFP+HDMP+Rituximab regimen |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Contacts
Primary ContactLEI FAN, M.D., Ph.D.
Outcome results
None listed