Clinical study of chemoimmunotherapy with fresh frozen plasma, high dose methylprednisolone and rituximab for ultra-high risk chronic lymphocytic leukemia

Clinical study of chemoimmunotherapy with fresh frozen plasma, high dose methylprednisolone and rituximab for ultra-high risk CLL

Status

Active, not recruiting

Phases

Phase 3

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR-ONC-12002442

Enrollment

Unknown

Registered

2012-08-17

Start date

2013-07-01

Completion date

Unknown

Last updated

2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ultra-high risk chronic lymphocytic leukemia

Interventions

experimental group:FFP+HDMP+Rituximab

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion 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-frfratory; 5. Understand and voluntarily sign an informed consent form, able to adhere to the study visit schedule and other protocol requirements.

Exclusion criteria

Exclusion criteria: 1. Severe allergic constitution or asthma; 2. Recent myocardial infarction or hypotension; 3. ECOG performance status of 1*10^3/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 investigtor considered ineligible for this study.

Design outcomes

Primary

Measure	Time frame
overall response rate;safety and toxicity;	—

Secondary

Measure	Time frame
PFS;OS;mortality;	—

Countries

China

Contacts

Public ContactWEI XU

xuwei10000@medmail.com.cn+86 25 6813 6034

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026