Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2012 by The First Affiliated Hospital with Nanjing Medical University.
Recruitment status was:  Recruiting
Sponsor:
Information provided by (Responsible Party):
WEI XU, Jiangsu Province Hospital
ClinicalTrials.gov Identifier:
NCT01670812
First received: August 19, 2012
Last updated: NA
Last verified: August 2012
History: No changes posted
  Purpose
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.

Condition Intervention Phase
Chronic Lymphocytic Leukemia
Drug: FFP+HDMP+Rituximab
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Study of Chemoimmunotherapy With Fresh Frozen Plasma, High Dose Methylprednisolone and Rituximab for Ultra-high Risk Chronic Lymphocytic Leukemia

Resource links provided by NLM:


Further study details as provided by The First Affiliated Hospital with Nanjing Medical University:

Primary Outcome Measures:
  • overall response rate [ Time Frame: one year ] [ Designated as safety issue: No ]
    overall response rate after treated by FFP+HDMP+Rituximab regimen


Secondary Outcome Measures:
  • progression free survival [ Time Frame: one year ] [ Designated as safety issue: No ]
    progression free survival after treatment of FFP+HDMP+Rituximab for ultra-high risk CLL patients.

  • overall survival [ Time Frame: one year ] [ Designated as safety issue: No ]
    overall survival after treatment of FFP+HDMP+Rituximab for ultra-high risk CLL patients

  • Number of Participants with Adverse Events [ Time Frame: up to 30 days after last dose of treatment ] [ Designated as safety issue: Yes ]
    Number of Participants with Adverse Events, and evaluated standard is according to common terminology criteria adverse events(CTCAE) version 4.0


Estimated Enrollment: 100
Study Start Date: January 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FFP+HDMP+Rituximab
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.
Drug: FFP+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
Other Names:
  • fresh frozen plasma
  • methylprednisolone
  • rituximab

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01670812

Locations
China, Anhui
The First affiliated Hospital of AnHui Medical Universtiy
Hefei, Anhui, China
China, Hubei
TongJi Hospital
Wuhan, Hubei, China
China, Jiangsu
ChangZhou First People's Hospital
ChangZhou, Jiangsu, China, 213003
ChangZhou No.2 People's Hospital
ChangZhou, Jiangsu, China, 213011
HuaiAn First People's Hospital
HuaiAn, Jiangsu, China, 223300
NanJing First People's Hospital
NanJing, Jiangsu, China, 210006
JiangSu Province Hospital
NanJing, Jiangsu, China, 210029
JiangSu Province Hospital of TCM
Nanjing, Jiangsu, China
WuXi People's Hospital
WuXi, Jiangsu, China, 214023
ZhenJiang First People's Hospital
ZhenJiang, Jiangsu, China, 212002
China, Shandong
Shandong Provincial Hospital
Jinan, Shandong, China
China, Shanghai
TongJi Medical University affiliated TongJi Hospital
Shanghai, Shanghai, China
China, Sichuan
West China School of Medicine, West China Hospital, Sichuan University
Chendu, Sichuan, China
China, Tianjin
Institute of Hematology & Blood Diseases Hospital
TianJin, Tianjin, China
Sponsors and Collaborators
The First Affiliated Hospital with Nanjing Medical University
Investigators
Principal Investigator: Wei Xu, M.D., Ph.D. The First Affiliated Hospital with Nanjing Medical University
  More Information

Publications:
Responsible Party: WEI XU, Professor, Jiangsu Province Hospital
ClinicalTrials.gov Identifier: NCT01670812     History of Changes
Other Study ID Numbers: JSPH-CLL-001 
Study First Received: August 19, 2012
Last Updated: August 19, 2012
Health Authority: China: Ministry of Health

Keywords provided by The First Affiliated Hospital with Nanjing Medical University:
chronic lymphocytic leukemia
ultra-high risk
fresh frozen plasma
methylprednisolone
rituximab

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Rituximab
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on January 17, 2017