Clinical trial NCT01676558: A Phase II Study of 131I-rituximab for Relapsed/Refractory Diffuse Large B Cell Lymphoma (DLBCL)
Official title: A Phase II Study of 131I-rituximab for Elderly or Poor Performance Status Patients With Diffuse Large B Cell Lymphoma (DLBCL) or for Adult Patients With Relapsed or Refractory DLBCL
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Relapsed or Refractory Diffuse Large B Cell Lymphoma
Keywords: diffuse large B cell lymphoma
radioimmunotherapy
131I-rituximab
Lead sponsor: Korea Cancer Center Hospital
Sponsor class: OTHER
First posted: 2012-08-31
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Diffuse large B cell lymphoma (DLBCL) is the most common type of non-Hodgkin lymphoma in Korea. Although there is standard therapy, which is called 'R-CHOP', many obstacles to use aggressive cytotoxic chemotherapeutic agents such as old age, poor performance status, refractoriness, and relapsed disease still remains. So we investigate the efficacy of radioimmunotherapy using 131I-rituximab in refractory or relapsed patients with DLBCL.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed diffuse large B cell lymphoma Elderly (\>65 years) or medically ineligible to standard cytotoxic chemotherapy due to poor performance status, or relapsed or refractory patients Eastern Cooperative Oncology Group performance status ≤ 2, age≥ 20 years Relapsed or refractory after autologous hematopoietic stem cell transplantation (auto-HSCT) in young patients with good performance status and indicated to high dose chemotherapy and auto-HSCT More than one measurable lesion
* More than 2cm sized lesion in conventional CT scan,
* More than 1cm sized lesion in spiral CT or contrast-enhanced PET/CT Adequate renal function (serum creatinine ≤ 2.0 mg/dl or Ccr ≥ 60 ml/min) Adequate hepatic function (serum bilirubin ≤ 2.0 mg/dl , AST/ALT ≤ 3 upper normal limit) Adequate bone marrow reservoir (ANC ≥1,500/㎕, platelet count≥ 75,000/㎕) patient who agree the purpose and intention of this clinical trial

Exclusion Criteria:

* recent (\<5 years) history of other malignancy or unrecovered from the disease (appropriately treated skin cancer and uterine cervix carcinoma in situ are excluded)

  * hemodynamically unstable due to the recent (\<12 months) history of severe heart disease such as myocardial infarction
  * acute complications of severe lung or metabolic disease
  * Combined severe neurological or psychiatric disease Unrecovered from infection or other medical disease Recent (\<30 days) history of enrollment of other clinical trial Pregnant or breast-feeding woman women of childbearing potential and men not employing adequate contraception at least for 1 year Previous history drug allergy to the content of 131I-rituximab Infection(sepsis, pneumonia, viral infection, etc) (inactivated hepatitis B carrier can be enrolled) Young patient with good performance status indicated to autologous hematopoietic stem cell transplantation irrespective of the failure of 1st line chemotherapy

Primary outcomes:
measure: overall response rate
timeFrame: up to 5 years
Secondary outcomes:
measure: Response duration
timeFrame: up to 5 years
measure: progression free survival
timeFrame: up to 5 years
measure: Overall survival
timeFrame: up to 5 years
measure: Number of Adverse event
timeFrame: up to 5 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea Cancer Center Hospital, Korea Institute of Radiological and Medical Sciences
city: Seoul
country: Korea, Republic of
facility: Korea Cancer Center Hospital, Korea Institute of Radiological and Medical Sciences
Study officials:
References: