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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Completed 18 and over NCI SWOG-8691 CAN-NCIC-HL1, CLB-8791, EST-2487, INT-0073, HL1

Objectives

I.  Compare, in a randomized Phase III setting, the clinical efficacy of 
2'-deoxycoformycin vs. alpha-interferon with regard to response rate, time to 
response, and duration of relapse-free survival in patients with previously 
untreated hairy cell leukemia.
II.  Compare the two treatment regimens with regard to improvement in the 
following specific patient characteristics:  hematologic parameters, spleen 
size, performance status, frequency of documented infections, and numbers of 
RBC and platelet transfusions.
III.  Estimate the response rate for each treatment when used among patients 
who failed to respond to or had unresolvable toxicity from the other treatment.
IV.  Determine the impact of CR vs. PR on duration of remission and on 
survival.
V.  Compare the toxicities associated with these two treatment regimens.

Entry Criteria

Disease Characteristics:

Histologically proven hairy cell leukemia demonstrated by
bone marrow biopsy within 56 days prior to registration

Active disease required as defined by any of the following:
  Abnormality in one or more blood cell line (Hgb less than
     12 g/dl, AGC less than 1,500, or platelets less than
     100,000)
  Recurrent infections requiring antibiotic therapy
  Symptomatic splenomegaly
  Circulating hairy cell count at least 20,000

Prior/Concurrent Therapy:

Biologic therapy:
  No prior interferon

Chemotherapy:
  No prior deoxycoformycin or other cytotoxic chemotherapy

Endocrine therapy:
  Prior corticosteroid or danazol therapy allowed

Radiotherapy:
  Not specified

Surgery:
  No prior splenectomy

Patient Characteristics:

Age:
  At least 18

Performance status:
  POG 0-3

Hematopoietic:
  See Disease Characteristics

Hepatic:
  Bilirubin no more than 2 mg/dl

Renal:
  Creatinine no more than 1.5 mg/dl
  Creatinine clearance more than 50 ml/min

Cardiovascular:
  Normal cardiac function, i.e., NYHA Class 2 or better
  (compensated or pharmacologically controlled angina
  pectoris, arrhythmias, and CHF allowed)

Other:
  No second malignancy except:
     Basal cell skin cancer
     Curatively treated carcinoma in situ of the cervix
  No pregnant or nursing women (women who become pregnant
     during therapy are removed from protocol)
  Adequate contraception required of fertile women
  No serious medical or psychiatric illness that precludes
     informed consent

Expected Enrollment

320 patients, 160 in each arm, will be randomized over about 4 years.  
Effective October, 1989, the study was temporarily closed to new patient 
registration, accrual goals having been achieved; registrations for crossover 
patients were still being received.

Outline

Randomized study.
Arm I:  Immunotherapy.  Alpha-Interferon, Interferon alpha-2a (Hoffman 
LaRoche), IFN-A, NSC-367982.
Arm II:  Single-agent Chemotherapy.  2'-Deoxycoformycin, DCF, NSC-218321.

Flinn IW, Kopecky KJ, Foucar MK, et al.: Long-term follow-up of remission duration, mortality, and second malignancies in hairy cell leukemia patients treated with pentostatin. Blood 96 (9): 2981-6, 2000.[PUBMED Abstract]

Grever M, Kopecky K, Foucar MK, et al.: Randomized comparison of pentostatin versus interferon alfa-2a in previously untreated patients with hairy cell leukemia: an intergroup study. J Clin Oncol 13 (4): 974-82, 1995.[PUBMED Abstract]

Grever M, Kopecky K, Head D, et al.: A randomized comparison of deoxycoformycin (DCF) vs alpha-2A interferon (IFN) in previously untreated patients with hairy cell leukemia (HCL): an NCI-sponsored intergroup study (SWOG, ECOG, CALGB, NCIC CTG). [Abstract] Proceedings of the American Society of Clinical Oncology 11: A-868, 1992.

Tallman MS, Hakimian D, Kopecky KJ, et al.: Minimal residual disease in patients with hairy cell leukemia in complete remission treated with 2-chlorodeoxyadenosine or 2-deoxycoformycin and prediction of early relapse. Clin Cancer Res 5 (7): 1665-70, 1999.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Southwest Oncology Group

Michael Grever, MD, Protocol chair		Ph: 614-293-8724 Email: michael.greever@osumc.edu

Eastern Cooperative Oncology Group

Peter A. Cassileth, MD, Protocol chair(Contact information may not be current)		Ph: 305-243-4977

Cancer and Leukemia Group B

Kanti Rai, MD, Protocol chair		Ph: 718-470-7135; 800-371-7111 Email: rai@lij.edu

NCIC-Clinical Trials Group

Elizabeth Eisenhauer, MD, Protocol chair		Ph: 613-533-6430 Email: eeisenhauer@ctg.queensu.ca