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Yt90Zevalin Plus CHOP, Z-CHOP

Phase 2
18 Years
75 Years
Not Enrolling
Diffuse Large B-cell Lymphoma

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Trial Information

Yt90Zevalin Plus CHOP, Z-CHOP

Radioimmunotherapy represents a significant advance over unlabeled immunotherapy for the
treatment of patients with B-cell non-Hodgkin's lymphoma. The radiobiological effects
associated with Yt90-labelled ibritumomab tiuxetan (Zevalin) include the induction of
apoptosis and cell-cycle redistribution.

The response rate tend to be higher in patients who have been treated with fewer prior
therapies and Yt90-labelled ibritumomab tiuxetan may be suitable for use early in the course
of therapy.

Yt90-labelled ibritumomab tiuxetan has less non hematologic toxicity than chemotherapy, with
only minimal alopecia, mucositis, nausea, or vomiting, and a lower incidence of infections.

Yt90-labelled ibritumomab tiuxetan regimen is routinely and safely given in an outpatient
setting and is completed in 7-9 days and is thus more convenient to be used.

Inclusion Criteria:

- Histologically confirmed CD20 positive diffuse large B-cell lymphoma with bulky stage
II or stage III or stage IV

- Bidimensionally measurable disease

- Performance status Zubrod 0-2

- Less than 20,000/mcL circulating lymphoid cells on WBC differential count

- No clinical evidence of CNS involvement, no prior diagnosis of indolent lymphoma, no
histologic transformation

- Ejection fraction more than or equal to 45% by MUGA or no significant abnormality by

- Fertile patients with effective contraception method

- No other malignancy within past 5 years except adequately treated basal cell or
squamous cell skin cancer, stage I or II cancer in complete remission, or carcinoma
in situ of cervix

- No HIV positive, no prior solid organ transplantation

- No prior antibody therapy, chemotherapy, radiotherapy for lymphoma

Exclusion Criteria:

- Serum creatinine ot bilirubin more than 2.5 X ULN unless due to lymphoma

- Active uncontrolled infection

- Concurrent severe and/or uncontrolled medical disease which could compromise
participation in the study

- Patients with more than 25% infiltrated bone marrow

- Patients with platelet counts less than 100,000/mcL or neutrophil counts less than

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

2-year progression-free survival and overall survival of patients

Principal Investigator

Udomsak Bunworasate, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Division of Hematology and Stem Cell Transplant, Department of Medicine, Faculty of Medicine, Chulalongkorn University


Thailand : Thai Food and Drug Administration

Study ID:




Start Date:

April 2006

Completion Date:

January 2010

Related Keywords:

  • Diffuse Large B-Cell Lymphoma
  • Zevalin
  • Zevalin plus CHOP
  • Diffuse large B-cell lymphoma
  • First line Diffuse large B-cell lymphoma
  • Lymphoma
  • Lymphoma, B-Cell
  • Lymphoma, Large B-Cell, Diffuse