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

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.

Sex

All

Minimum age

18 Years

Maximum age

80 Years

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

• BACKGROUNDXu W, Miao KR, Zhu DX, Fang C, Zhu HY, Dong HJ, Wang DM, Wu YJ, Qiao C, Li JY. Enhancing the action of rituximab by adding fresh frozen plasma for the treatment of fludarabine refractory chronic lymphocytic leukemia. Int J Cancer. 2011 May 1;128(9):2192-201. doi: 10.1002/ijc.25560. PMID 20635386
• BACKGROUNDXu W, Miao KR, Hong M, Zhu DX, Fang C, Dong HJ, Wang DM, Cao X, Li JY. High-dose methylprednisolone can induce remissions in patients with fludarabine-refractory chronic lymphocytic leukaemia. Eur J Cancer. 2010 Aug;46(12):2145-9. doi: 10.1016/j.ejca.2010.04.021. Epub 2010 Jun 4. PMID 20627536
• BACKGROUNDDungarwalla M, Evans SO, Riley U, Catovsky D, Dearden CE, Matutes E. High dose methylprednisolone and rituximab is an effective therapy in advanced refractory chronic lymphocytic leukemia resistant to fludarabine therapy. Haematologica. 2008 Mar;93(3):475-6. doi: 10.3324/haematol.11903. PMID 18310545
• BACKGROUNDKlepfish A, Gilles L, Ioannis K, Rachmilewitz EA, Schattner A. Enhancing the action of rituximab in chronic lymphocytic leukemia by adding fresh frozen plasma: complement/rituximab interactions & clinical results in refractory CLL. Ann N Y Acad Sci. 2009 Sep;1173:865-73. doi: 10.1111/j.1749-6632.2009.04803.x. PMID 19758239