Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Related Publications
Trial Contact Information
Registry Information

Alternate Title

Combination Chemotherapy Plus Monoclonal Antibody Therapy in Treating Patients With Non-Hodgkin's Lymphoma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	18 and over	NCI	SWOG-9911 NCT00003784, S9911

Objectives

I.   Determine the 2 year failure free survival rate of patients with newly 
diagnosed follicular lymphoma treated with cyclophosphamide, doxorubicin, 
vincristine, and prednisone (CHOP) followed by iodine I 131 monoclonal 
antibody anti-B1.

II.  Determine the complete and partial response rates of these patients after 
this therapy.

III. Evaluate the toxicity of this regimen in these patients.

IV.  Determine the rate of disappearance of cells with clonal t(14;18)/bcl2 
rearrangements from the peripheral blood and bone marrow after this therapy in 
these patients.

Entry Criteria

Disease Characteristics:

Histologically confirmed follicular non-Hodgkin's lymphoma
 No prior treatment
 Bulky stage II, stage III, or stage IV
 Must express CD20 antigen

Bidimensionally measurable disease

No CNS involvement

Prior/Concurrent Therapy:

Biologic therapy:
 No prior monoclonal antibodies

Chemotherapy:
 No prior chemotherapy for lymphoma

Endocrine therapy:
 Not specified

Radiotherapy:
 No prior radiotherapy for lymphoma

Surgery:
 Not specified

Patient Characteristics:

Age:
 18 and over

Performance status:
 SWOG 0-2

Life expectancy:
 Not specified

Hematopoietic:
 Granulocyte count at least 1500/mm3
 Platelet count at least 100,000/mm3

Hepatic:
 Not specified

Renal:
 Not specified

Cardiovascular:
 No arrhythmias (except sinus arrhythmia or infrequent premature ventricular
  contractions)
 No history of impaired cardiac status (severe coronary artery disease,
  cardiomyopathy, congestive heart failure, or serious arrhythmia
 Ejection fraction at least normal

Other:
 HIV negative
 No prior malignancy within past 5 years except adequately treated basal cell
  or squamous cell skin cancer or carcinoma in situ of the cervix
 No pregnant or nursing
 Fertile patients must use effective contraception

Expected Enrollment

A total of 80 patients will be accrued for this study within 1 year.

Outline

Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV, and 
vincristine IV on day 1 and oral prednisone on days 1-5.  Treatment is 
repeated every 21 days for up to 6 courses.

Within 4-8 weeks after the last course of chemotherapy, patients who achieve 
at least a partial response and have less than 25% bone marrow involvement 
begin immunotherapy.  Patients receive unlabeled monoclonal antibody anti-B1 
(MOAB anti-B1) IV over 1 hour, then iodine I 131 MOAB anti-B1 IV over 20 
minutes on day 1.  This regimen is repeated on day 8.

Patients are followed every 6 months for 2 years, then annually thereafter.

Press OW, Unger JM, Braziel RM, et al.: Phase II trial of CHOP chemotherapy followed by tositumomab/iodine I-131 tositumomab for previously untreated follicular non-Hodgkin's lymphoma: five-year follow-up of Southwest Oncology Group Protocol S9911. J Clin Oncol 24 (25): 4143-9, 2006.[PUBMED Abstract]

Press OW, Unger J, Maloney D, et al.: An update of a phase II trial of CHOP followed by tositumomab/iodine I-131 tositumomab (Bexxar®) for front-line treatment of advanced stage, follicular lymphoma: Southwest Oncology Group Protocol 9911. [Abstract] Blood 106 (11): A-352, 2005.

Press OW, Unger JM, Braziel RM, et al.: A phase 2 trial of CHOP chemotherapy followed by tositumomab/iodine I 131 tositumomab for previously untreated follicular non-Hodgkin lymphoma: Southwest Oncology Group Protocol S9911. Blood 102 (5): 1606-12, 2003.[PUBMED Abstract]

Press OW, Unger JM, Braziel RM, et al.: A phase II trial of CHOP followed by Bexxar™ (tositumomab and iodine-131-tositumomab) for treatment of newly diagnosed follicular non-Hodgkin’s lymphomas (SWOG 9911). [Abstract] Blood 98 (11 Pt 1): A-3504, 2001.

Hsi ED, Rimsza L, Goldman BH, et al.: MUM1 expression in follicular lymphoma is a poor prognostic marker in patients treated with immunochemotherapy (SWOG 9800/9911) but not chemotherapy alone (SWOG 8809): a Southwest Oncology Group correlative science study. [Abstract] Blood 112 (11): A-376, 2008.

Fisher RI, LeBlanc M, Press OW, et al.: New treatment options have changed the survival of patients with follicular lymphoma. J Clin Oncol 23 (33): 8447-52, 2005.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Southwest Oncology Group

Oliver Press, MD, PhD, Protocol chair(Contact information may not be current)		Ph: 206-667-1872

Registry Information
Official Title		A Phase II Pilot Trial of CHOP Followed by Iodine-131-Labeled Monoclonal Anti-B1 Antibody for Treatment of Newly Diagnosed Follicular Non-Hodgkin's Lymphomas
Trial Start Date		1999-05-15
Registered in ClinicalTrials.gov		NCT00003784
Date Submitted to PDQ		1999-02-22
Information Last Verified		2008-12-29
NCI Grant/Contract Number		CA32102