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A Phase II Trial of R-CHOP Followed by Zevalin Radioimmunotherapy for Patients With Previously Untreated Stages I and II CD20+ Diffuse Large Cell Non-Hodgkin's Lymphoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Contiguous Stage II Adult Diffuse Large Cell Lymphoma, Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue, Nodal Marginal Zone B-cell Lymphoma, Noncontiguous Stage II Adult Diffuse Large Cell Lymphoma, Splenic Marginal Zone Lymphoma, Stage I Adult Diffuse Large Cell Lymphoma, Testicular Lymphoma, Waldenström Macroglobulinemia

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Trial Information

A Phase II Trial of R-CHOP Followed by Zevalin Radioimmunotherapy for Patients With Previously Untreated Stages I and II CD20+ Diffuse Large Cell Non-Hodgkin's Lymphoma


PRIMARY OBJECTIVES:

I. To evaluate the complete response rate (CR) and functional CR rate (CR or Cru/PR and PET
negative) in patients with previously untreated stage I (with at least 1 risk factor) or
stage II CD20+ diffuse large cell lymphoma who receive therapy with RCHOP followed by 90Y
-Zevalin™.

SECONDARY OBJECTIVES:

I. To evaluate the time to treatment failure, duration of response, and overall survival in
these patients who receive therapy with R-CHOP followed by 90Y -Zevalin™.

II. To evaluate the toxicity of this therapy. III. To evaluate the toxicity of adding
involved field radiation therapy > 12 weeks after Zevalin™ for patients with CT+/PET+
residual masses.

TERTIARY OBJECTIVES:

I. To evaluate PET scans pre -and post - R-CHOP/Zevalin™ therapy.

OUTLINE:

Monoclonal antibody (MOAB) therapy/chemotherapy: Patients receive oral prednisone once daily
on days 1-5. Patients also receive rituximab IV over several hours followed by
cyclophosphamide IV, doxorubicin IV, and vincristine IV over 30-60 minutes on day 1.
Treatment repeats every 21 days for 2 courses in the absence of disease progression or
unacceptable toxicity. Patients achieving a complete response (CR) after 2 courses receive 2
additional courses. Patients achieving a partial response, uncertain CR, or stable disease
receive 4 additional courses. Patients are evaluated 3 weeks after the last course of
therapy. Patients with progressive disease go off study.

MOAB therapy/radioimmunotherapy: Beginning no more than 9 weeks after the last course of
MOAB therapy and chemotherapy, patients receive rituximab IV on day 1 followed by indium In
111 ibritumomab tiuxetan IV over 10 minutes for imaging studies. Patients then receive
rituximab IV followed by yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 8.

Radiotherapy: Patients with residual disease by CT scan or positron emission tomography
(PET) scan after 12 weeks after radioimmunotherapy undergo conventional involved-field
radiotherapy.

Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months
for 3 years, and then annually for 5 years.


Inclusion Criteria:



- Patients must have histologically confirmed diagnosis of diffuse large cell lymphoma

- Patients must be stage I or II (Modified Ann Arbor staging)

- Baseline measurements and evaluations must be obtained within 4 weeks of registration
to the study; abnormal PET scans will not constitute evaluable disease unless
verified by CT scan or other appropriate imaging; patients must have at least one
objective measurable disease parameter (a lesion with at least 1 dimension > 1.5 cm);
or if they are stage 1

- Stage I patients must have at least one of the following risk factors:

- Age >= 60 years

- Bulky disease (>= 5 cm in at least one dimension)

- Elevated LDH above institutional upper limit of normal

- ECOG performance status = 2

- Patients must not have had prior chemotherapy, radiation therapy, radioimmunotherapy,
or immunotherapy; a short course (=< 14 days prior to registration) of
corticosteroids is allowed

- ECOG performance status 0-2

- Absolute neutrophil count >= 1500/mm^3 (includes neutrophils and bands)

- Platelet count >= 100,000/mm^3

- Creatinine < 2.0 mg/dl

- Total bilirubin < 2 mg/dl (may be up to 3.0 mg/dl if due to liver involvement by
lymphoma); patients with elevated total bilirubin should have a direct bilirubin
checked; if the direct bilirubin is normal there is no need for a dose reduction

- Patients must have no evidence of other malignancy

- No prior chemotherapy or prior radiation therapy for other malignancies

- Not currently receiving hormone therapy or chemotherapy for another malignancy
even if the treatment is being provided in the adjuvant treatment setting, i.e.
with no evidence of the original other malignancy

- Adjuvant hormonal therapy must have been discontinued > 3 months before entering
this study

- Patients are eligible if they meet the following conditions: (a) treated
carcinoma-in-situ of the cervix; (b) treated squamous cell or basal cell skin
cancer; or (c) any other surgically cured malignancy from which the patient has
been disease free for at least 3 years

- Female patients must not be pregnant or breast feeding, as there would be radiation
exposure to the fetus or child; a negative pregnancy test is required =< 1 week prior
to registration for women of childbearing potential (WOCBP)

- Women of childbearing potential and sexually active males must be strongly advised to
use an accepted and effective method of contraception

- Patients must not have known CNS lymphoma, testicular lymphoma, or vitreous lymphoma

- Patients must have no known HIV infection. The safety of Zevalin™ in this population
has not been tested at this time

- Patients must not have a serious coexisting medical condition or active infection
which would compromise the ability to deliver standard R-CHOP chemotherapy

- Patients must have LV ejection fraction of > 45%

- No evidence of myelodysplasia on bone marrow aspiration and biopsy

- Patients must be tested for hepatitis B surface antigen within 2 weeks of
registration

- NOTE: Patients who test positive will be allowed to participate but must be
followed closely for clinical and laboratory signs of active HBV infection and
for signs of hepatitis

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Complete response rate (CR/CRu)

Outcome Time Frame:

Up to 10 years

Safety Issue:

No

Principal Investigator

Thomas Witzig

Investigator Role:

Principal Investigator

Investigator Affiliation:

Eastern Cooperative Oncology Group

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-02957

NCT ID:

NCT00088881

Start Date:

December 2004

Completion Date:

Related Keywords:

  • Contiguous Stage II Adult Diffuse Large Cell Lymphoma
  • Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
  • Nodal Marginal Zone B-cell Lymphoma
  • Noncontiguous Stage II Adult Diffuse Large Cell Lymphoma
  • Splenic Marginal Zone Lymphoma
  • Stage I Adult Diffuse Large Cell Lymphoma
  • Testicular Lymphoma
  • Waldenström Macroglobulinemia
  • Lymphoma
  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, Non-Hodgkin
  • Waldenstrom Macroglobulinemia
  • Lymphoma, B-Cell
  • Lymphoma, B-Cell, Marginal Zone

Name

Location

Eastern Cooperative Oncology GroupBoston, Massachusetts  02215