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

Phase 3
18 Years
80 Years
Open (Enrolling)
Chronic Lymphocytic Leukemia

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Trial Information

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

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.

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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

overall response rate

Outcome Description:

overall response rate after treated by FFP+HDMP+Rituximab regimen

Outcome Time Frame:

one year

Safety Issue:


Principal Investigator

Wei Xu, M.D., Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Jiangsu Province Hospital


China: Ministry of Health

Study ID:




Start Date:

January 2012

Completion Date:

June 2014

Related Keywords:

  • Chronic Lymphocytic Leukemia
  • chronic lymphocytic leukemia
  • ultra-high risk
  • fresh frozen plasma
  • methylprednisolone
  • rituximab
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid