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Yt90 Zevalin & Combination Chemotherapy in Treating Patients With Stage II,Stage III,or Stage IV Diffuse Large B-cell Lymphoma


Phase 2
18 Years
75 Years
Open (Enrolling)
Both
Patients With Diffuse Large B-cell Lymphoma Who Achieved at Least Unconfirmed Partial Remission After 6 Cycles of CHOP Therapy.

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Trial Information

Yt90 Zevalin & Combination Chemotherapy in Treating Patients With Stage II,Stage III,or Stage IV Diffuse Large B-cell Lymphoma


Diffuse large B-cell lymphomas (DLBCL) are the most common lymphoid neoplasm and account for
30% to 40% of adult non-Hodgkin lymphomas (NHL). DLCBL is a potentially curable disease. The
ultimate goals of introducing new modality treatments such as monoclonal antibody
(Ab)-targeted therapy are to increase complete remission (CR) rate and prolong event-free
survival and overall survival.In phase II trials, it was shown that in DLBL the addition of
rituximab to CHOP was feasible, with an increase in ORR, including CR and an increase in the
OS and PFS in patients with DLBL.2 The benefit of R-CHOP was consistent across all subgroups
of patients tested, including good and poor risks according to IPI and independent of
younger than 70 years and older than 70 years of age.

Recently, new radiolabeled monoclonal antibodies have been established in the therapy of
malignant lymphoma which can induce high remission rates. Radiolabeled antibodies are
particularly effective as lymphoma cells are highly sensitive to radiation. In addition, the
local emission of radiolabeled antibodies is able to destroy cells in close proximity to the
bound antibody (bystander effect) therefore circumventing the problem of limited perfusion
of bulky or poorly vascularized tumors.Ibritumomab is covalently linked to the tiuxetan
chelate and radiolabeled with Yt90, producing Yt90-ibritumomab tiuxetan (Yt90-Zevalin). To
optimize biodistribution, Rituximab is given prior to the radiolabeled antibody.
Yt90-ibritumomab-tiuxetan-treatment was compared to a standard course of Rituximab. ORR in
the Yt90-ibritumomab tiuxetan group was significantly higher than ORR in the Rituximab group
(80% vs. 56% according to International Workshop Response criteria or 73% vs. 47% according
to protocol-defined evaluation of response).

Since radioimmunotherapy represents a significant advance over unlabeled immunotherapy for
the treatment of patients with B-cell non-Hodgkin's lymphoma, it is worthwhile to study the
consolidation therapy with Yt90-ibritumomab tiuxetan (Yt90-Zevalin) in patients who achieved
at least unconfirmed partial remission after 6 cycles of CHOP therapy.


Inclusion Criteria:



- Histologically confirmed, CD 20 positive diffuse large B-cell lymphoma, meeting 1
of the following stage criteria: Bulky stage II disease, Stage III disease, Stage IV
disease at the initial diagnosis.

- Bidimensionally measurable disease

- Age 18 - 75 Years

- Performance status Zubrod 0-2

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

- Adequate sections AND a paraffin block OR ≥ 10 unstained sections from the original
diagnostic specimen available

- Needle aspiration or cytology are not considered adequate

- No clinical evidence of CNS involvement by lymphoma

- No prior diagnosis of indolent lymphoma

- No histologic transformation

- Life expectancy : Not specified

- Hepatic : Not specified

- Renal : Not specified

- Cardiovascular

- Ejection fraction ≥ 45% by MUGA OR

- No significant abnormalities by echocardiogram

- Pulmonary : No requirement for continuous supplemental oxygen

- Other

- All adult patients of reproductive potential must use contraception during and
for 6 months after completion of study treatment

- No other malignancy within the 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 the cervix

- No known HIV positive

- Written informed consent

- PRIOR CONCURRENT THERAPY:

- Biologic therapy : No prior antibody therapy for lymphoma

- Chemotherapy : 6 cycles of CHOP

- Endocrine therapy : Not specified

- Radiotherapy : No prior radiotherapy for lymphoma

- Surgery : No prior solid organ transplantation

Exclusion Criteria:

- Previous antineoplastic treatment other than the 6 cycles of CHOP for the initial
treatment of DLBCL

- Positive HIV serology

- Positive serology of HCV with the presence of HCV RNA of chronic hepatitis

- Positive serology of HBV with the presence of HBV RNA of chronic hepatitis

- Serum creatinine or bilirubin > 2.5 x upper limit of normal

- Active uncontrolled infection

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

- Patients in whom more than 25% of the bone marrow has been infiltrated by lymphoma
cells

- Patients with platelet counts <100,000/µl or neutrophil counts < 1500/µl

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

- Determine the 2-years progression-free survival of consolidation therapy with Yt90-Zevalin.

Outcome Time Frame:

2 year

Safety Issue:

Yes

Principal Investigator

Surapol Issaragrisil, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Siriraj Hospital

Authority:

Thailand: Food and Drug Administration

Study ID:

TH011101

NCT ID:

NCT00440583

Start Date:

September 2006

Completion Date:

March 2012

Related Keywords:

  • Patients With Diffuse Large B-cell Lymphoma Who Achieved at Least Unconfirmed Partial Remission After 6 Cycles of CHOP Therapy.
  • CHOP-Z
  • Lymphoma
  • Lymphoma, B-Cell
  • Lymphoma, Large B-Cell, Diffuse

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