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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


Phase 2
20 Years
N/A
Open (Enrolling)
Both
Relapsed or Refractory Diffuse Large B Cell Lymphoma

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

overall response rate

Outcome Description:

International Working Group Response criteria

Outcome Time Frame:

up to 5 years

Safety Issue:

No

Authority:

Korea: Food and Drug Administration

Study ID:

DLBCL_131I-rituximab RIT

NCT ID:

NCT01676558

Start Date:

June 2012

Completion Date:

June 2017

Related Keywords:

  • Relapsed or Refractory Diffuse Large B Cell Lymphoma
  • diffuse large B cell lymphoma
  • radioimmunotherapy
  • 131I-rituximab
  • Lymphoma
  • Lymphoma, B-Cell
  • Lymphoma, Large B-Cell, Diffuse

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