Clinical trial NCT01181999: Rituximab Augmentation Following R-CHOP Induction Chemotherapy in Extremely Elderly Patients With Diffuse Large B Cell Lymphoma
Official title: 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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Lymphoma, Large B-cell, Diffuse
Keywords: diffuse large B-cell lymphoma
elderly patients
rituximab augmentation
Lead sponsor: Chonnam National University Hospital
Sponsor class: OTHER
Collaborators: name: Samsung Medical Center
name: Asan Medical Center
name: Severance Hospital
First posted: 2010-08-16
Enrollment: 50
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility criteria: Inclusion Criteria:

1. Histologically confirmed CD20 positive DLBCL
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:

1. Other subtypes of non-Hodgkin's lymphoma
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

Primary outcomes:
measure: the overall response rate
timeFrame: three years after the completion of rituximab augmentation
measure: Number of patients with adverse events
timeFrame: three years
Secondary outcomes:
measure: progression-free survival
timeFrame: Three years after the completion of rituximab augmentation
Other outcomes:
Locations:
city: Jeollanam-do
country: Korea, Republic of
facility: Chonnam National University Hwasun Hosptial
Study officials:
References: