Rituximab Augmentation Following R-CHOP Induction Chemotherapy in Extremely Elderly Patients With Diffuse Large B Cell Lymphoma
NCT ID: NCT01181999
Last Updated: 2011-09-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE2
50 participants
INTERVENTIONAL
2010-08-31
2014-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The study is aimed to evaluate the overall response rate and the safety of four cycles of R-CHOP chemotherapy and followed by rituximab augmentation (weekly four times infusion) in newly diagnosed DLBCL patients with aged more than 70 years.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
If patients with CCI \<1
* Rituximab: 375 mg/m2, day 1 every 3 weeks.
* Conventional dose of CHOP chemotherapy repeat every 3 weeks.
If patients with CCI ≥1
* Rituximab: 375 mg/m2, day 1 every 3 weeks.
* 75% of conventional CHOP repeat every 3 weeks.
2. Rituximab augmentation
* Rituximab: 375 mg/m2, every week x 4 times.
* Trimethoprim-sulfamethoxazole 1 tablet per day during augmentation
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
rituximab
rituximab
A dose of 375mg/m2 rituximab will be administered intravenously on day 1 of first to fourth R-CHOP chemotherapy and on day 1, 8, 15, 22 of each augmentation chemotherapy.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
rituximab
A dose of 375mg/m2 rituximab will be administered intravenously on day 1 of first to fourth R-CHOP chemotherapy and on day 1, 8, 15, 22 of each augmentation chemotherapy.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Age ≥ 70
3. Ann Arbor stage II, III and IV
4. No prior chemotherapy or radiotherapy for DLBCL
5. Performance status (Eastern Cooperative Oncology Group) ≤ 2
6. At least one or more bidimensionally measurable lesion(s)
* ≥ 2 cm by conventional computerized tomography (CT)
* ≥ 1 cm by spiral CT
* skin lesion (photographs should be taken) ≥ 2 cm
* measurable lesion by physical examination ≥ 2 cm
7. Cardiac ejection fraction ≥ 50% as measured by echocardiogram without clinically significant abnormalities
8. Adequate renal function: serum creatinine level \< 2 mg/dL (177 μmol/L)
9. Adequate liver functions:
10. Adequate bone marrow functions:
hemoglobin ≥ 9 g/dL absolute neutrophil count ≥ 1,500/μL and platelet count ≥ 75,000/μL, unless abnormalities are due to bone marrow involvement by lymphoma
11. Life expectancy more than 6 months
12. Informed consent
Exclusion Criteria
2. Patients who transformed follicular lymphoma or other indolent lymphoma
3. Primary Central Nervous System (CNS) DLBCL
4. CNS involvement by lymphoma or any evidence of spinal cord compression.
5. Patients with a known history of human immunodeficiency virus (HIV) seropositivity or hepatitis C virus (+).
6. Any other malignancies within the past 5 years except curatively treated non-melanoma skin cancer or in situ carcinoma of cervix uteri
7. Pregnant or lactating women, women of childbearing potential not employing adequate contraception
8. Other serious illness or medical conditions
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Samsung Medical Center
OTHER
Asan Medical Center
OTHER
Severance Hospital
OTHER
Chonnam National University Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Deok-Hwan Yang
Professor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Chonnam National University Hwasun Hosptial
Jeollanam-do, , South Korea
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ML25393
Identifier Type: -
Identifier Source: org_study_id