Phase II Study of Fludarabine/Mitoxantrone for Previously Untreated Low-Grade, Stage III/IV Adult non-Hodgkin's Lymphoma (Summary Last Modified 08/96)

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Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IITreatmentClosedover 15NCISWOG-9501


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:

  Over 15

Performance status:
  SWOG 0-2

  Bilirubin no greater than 2 times normal

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

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

  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.


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

Published Results

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

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.