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

• Status: Unknown status
• Trial end date: 2014-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University
• Treatments: Methylprednisolone; Methylprednisolone acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Rituximab

Criteria

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