Phase II Trial of Rituximab (R) Augmentation Following R-CHOP (Cyclophosphamide, Doxorubicin, Vincristine, and Prednisolone) Induction Chemotherapy in Extremely Elderly Patients With Diffuse Large B Cell Lymphoma (DLBCL)
Overview
- Phase
- Phase 2
- Intervention
- rituximab
- Conditions
- Lymphoma, Large B-cell, Diffuse
- Sponsor
- Chonnam National University Hospital
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- the overall response rate
- Last Updated
- 14 years ago
Overview
Brief Summary
Rituximab (R) plus CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisolone) combination is considered as the new gold standard for the first-line treatment of elderly patients with diffuse large B-cell lymphoma (DLBCL).
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
1. Four cycles of R-CHOP chemotherapy for the induction treatment \[Dose intensity of CHOP chemotherapy is modulated according to Charlson Comorbidity Index (CCI)\] 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
Investigators
Deok-Hwan Yang
Professor
Chonnam National University Hospital
Eligibility Criteria
Inclusion Criteria
- •Histologically confirmed CD20 positive DLBCL
- •Ann Arbor stage II, III and IV
- •No prior chemotherapy or radiotherapy for DLBCL
- •Performance status (Eastern Cooperative Oncology Group) ≤ 2
- •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
- •Cardiac ejection fraction ≥ 50% as measured by echocardiogram without clinically significant abnormalities
Exclusion Criteria
- •Other subtypes of non-Hodgkin's lymphoma
- •Patients who transformed follicular lymphoma or other indolent lymphoma
- •Primary Central Nervous System (CNS) DLBCL
- •CNS involvement by lymphoma or any evidence of spinal cord compression.
- •Patients with a known history of human immunodeficiency virus (HIV) seropositivity or hepatitis C virus (+).
- •Any other malignancies within the past 5 years except curatively treated non-melanoma skin cancer or in situ carcinoma of cervix uteri
- •Pregnant or lactating women, women of childbearing potential not employing adequate contraception
- •Other serious illness or medical conditions
Arms & Interventions
rituximab
Intervention: rituximab
Outcomes
Primary Outcomes
the overall response rate
Time Frame: three years after the completion of rituximab augmentation
To evaluate the objective overall response rate of four cycles of R-CHOP and followed by four times weekly rituximab augmentation in exteremely elderly patients with DLBCL.
Number of patients with adverse events
Time Frame: three years
All patients will be evaluated for the toxicity during the treatment. Toxicity is graded according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC v3.0).
Secondary Outcomes
- progression-free survival(Three years after the completion of rituximab augmentation)