Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	over 15	NCI	SWOG-9501

Objectives

I.  Estimate the 2-year progression-free survival of adult patients with 
previously untreated low-grade, stage III/IV non-Hodgkin's lymphoma treated 
with fludarabine/mitoxantrone.

II.  Evaluate the toxicity of fludarabine/mitoxantrone in these patients.

Entry Criteria

Disease Characteristics:

Biopsy-proven low-grade non-Hodgkin's lymphoma
  Working Formulation A-C
  Original diagnostic sections required for SWOG pathology review
     Biopsies must be adequate to determine architectural pattern
     No bone marrow biopsy or needle aspirate/biopsy

Previously untreated stage III/IV (Ann Arbor)
  No CNS involvement
  No prior lymphoma or Hodgkin's disease

Disease bidimensionally measurable, i.e.:
  Plain x-ray with 1 diameter 0.5 cm or greater (bone lesions not included)
  CT, MRI, other imaging scan with both diameters greater than the distance
     between cuts
  Palpable lesion with both diameters 2 cm or greater

Concurrent registration on protocols SWOG-8947 (serum study) and SWOG-8819
(tissue study) encouraged

Prior/Concurrent Therapy:

No prior therapy

Patient Characteristics:

Age:
  Over 15

Performance status:
  SWOG 0-2

Hepatic:
  Bilirubin no greater than 2 times normal

Renal:
  Creatinine no greater than 2 times normal OR
  Creatinine clearance at least 60 mL/min

Cardiovascular:
  No severe coronary artery disease
  No cardiomyopathy
  No congestive heart failure
  No arrhythmia
  Left ventricular ejection fraction normal by ECHO or MUGA if history
     questionable

Other:
  No known AIDS syndrome or HIV-associated complex
  No second malignancy within 5 years except:
     Adequately treated nonmelanomatous skin cancer
     Adequately treated in situ cervical cancer
  No pregnant or nursing women
  Effective contraception required of fertile patients

Expected Enrollment

80 patients will be entered over 10-12 months.

Outline

2-Drug Combination Chemotherapy.  FN:  Fludarabine, FAMP, NSC-312887; 
Mitoxantrone, DHAD, NSC-301739.

Velasquez WS, Lew D, Grogan TM, et al.: Combination of fludarabine and mitoxantrone in untreated stages III and IV low-grade lymphoma: S9501. J Clin Oncol 21 (10): 1996-2003, 2003.[PUBMED Abstract]

Velasquez W, Lew D, Miller T, et al.: Phase II trial of a combination of fludarabine and mitoxantrone (FN) in untreated advanced low grade lymphoma: an effective, well tolerated therapy. [Abstract] Proceedings of the American Society of Clinical Oncology 18: A27, 9a, 1999.

Trial Contact Information

Trial Lead Organizations

Southwest Oncology Group

William S. Velasquez, MD, FACP, Protocol chair		Ph: 409-772-1164 Email: wvelasqu@utmb.edu