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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Completed over 15 NCI CLB-8582 SWOG-8694, CALGB-8582

Objectives

I.  Compare the frequency of response obtained with pentostatin with that 
obtained with alpha-interferon in patients with hairy cell leukemia who have 
active or progressive disease following splenectomy.
II.  Compare the times to response and response durations obtained by these 
two treatments.
III.  Determine whether pentostatin salvages nonresponders to alpha-interferon 
treatment and whether alpha-interferon salvages nonresponders to pentostatin 
treatment.
IV.  Compare the toxicity of the two treatments.

Entry Criteria

Disease Characteristics:

Histologically documented hairy cell leukemia with the
following:

  Tartrate-resistant acid phosphatase (TRAP) positive hairy
  cells in the peripheral blood and bone marrow

  Bone marrow biopsy demonstrating a mononuclear cell
  infiltrate with clear areas around cells with rare mitoses

Active disease required, defined as any of the following:

  Blood transfusion requirement of more than 2 units/month

  Decline in abnormally low peripheral blood hgb/hct,
  platelets, or absolute granulocyte count by more than 25%
  of baseline values

  Recurrent infections

  Progressive decrease in performance status of more than 20%
  (Karnofsky scale) over a 3-month period

Prior/Concurrent Therapy:

Biologic therapy:
  No prior interferon

Chemotherapy:
  No prior pentostatin
  At least 4 weeks since prior chemotherapy

Endocrine therapy:
  Not specified

Radiotherapy:
  Not specified

Surgery:
  Splenectomy required at least 3 months prior to entry
  At least 2 weeks since any other prior surgery

Patient Characteristics:

Age:
  15 and over

Performance status:
  CALGB 0-2 (up to 20 CALGB 3 or 4 patients may be entered)

Hematopoietic:
  See Disease Characteristics

Hepatic:
  Bilirubin no more than 1.5 x normal
  SGOT no more than 1.5 x normal
  SGPT no more than 1.5 x normal

Renal:
  Creatinine no more than 1.5 mg/dl OR
  Creatinine clearance at least 60 ml/min

Other:
  No pregnant women
  No second malignancy except:
     Curatively treated carcinoma in situ of the cervix
     Basal cell carcinoma of the skin
  No serious medical or psychiatric illness that would
  preclude informed consent

Expected Enrollment

130 patients (65 per arm) will be randomized.  It is estimated that accrual 
will continue for approximately 4 years.

Outline

Randomized study.
Arm I:  Biological Response Modifier Therapy.  Alpha-2-Interferon, IFN-A, 
NSC-377523.
Arm II:  Single-agent Chemotherapy.  2'-Deoxycoformycin, Pentostatin, DCF, 
NSC-218321.

Trial Contact Information

Trial Lead Organizations

Cancer and Leukemia Group B

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

Southwest Oncology Group

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