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 III Treatment Closed physiologic age 18 to 65 NCI CLB-9254 E-C9254, CALGB-9254

Objectives

I.  Compare the disease-free survival of patients with relapsed/refractory 
B-cell lymphoma who are in complete remission following bone marrow 
ablation/rescue and who are randomized to treatment with monoclonal antibody 
anti-B4 conjugated with blocked ricin and administered by 7-day continuous 
infusion vs. no further therapy.

Entry Criteria

Disease Characteristics:

In CR (or CR with residual abnormality) 60-120 days post-transplant
  NED at all previously involved sites documented within 14 days prior to
  entry, as follows:
     Negative CT
     Negative bilateral bone marrow biopsies (unilateral biopsy if marrow not
        previously involved)
     Negative gallium scan if tumor previously gallium-avid
  No new sites of disease


Bone marrow involvement no more than 20% at time of harvest
  Purging required if involved ABM used

Lymphoma cells in peripheral blood allowed
  Purging required if involved PBPC used

Concurrent enrollment of women on companion protocol CLB-9662 allowed

Prior/Concurrent Therapy:

Biologic therapy:
  Not specified

Chemotherapy:
  No post-transplant chemotherapy

Endocrine therapy:
  No estrogen therapy concurrently and for 28 days following anti-B4-bR
     therapy
  At least 14 days since corticosteroids

Radiotherapy:
  No post-transplant radiotherapy

Surgery:
  Not specified

  Not specified

Patient Characteristics:

Age:
  18 to 65 (physiologic) at time of ABM/PBPC

Performance status:
  CALGB 0-2

Hematopoietic:
  (must be stable for at least 5 days without transfusion)
  Absolute neutrophil count at least 500/mm3
  Platelet count at least 50,000/mm3
  Hematocrit at least 25%

Hepatic:
  Bilirubin no greater than 2.0 mg/dL
  AST and ALT no greater than 3 times normal

Renal:
  Creatinine no greater than 2.0 mg/dL

Cardiovascular:
  No significant heart disease (NYHA class III/IV)
  No angina pectoris
  No myocardial infarction within 6 months

Other:
  Negative post-transplant HIV test required 
  No disseminated intravascular coagulation
  No history of veno-occlusive disease
  No history of hemolytic uremic syndrome
  No requirement for corticosteroids
  No active infection
     Prophylactic antibiotics, gamma globulin, etc. allowed
  No other life-threatening condition unrelated to NHL
  No pregnant women
  Effective contraception required of fertile patients

Expected Enrollment

Approximately 388 patients will be registered over 1.5 years in order to 
accrue 232 randomized patients.

Outline

Randomized study.

Arm I:  Adjuvant Biological Response Modifier Therapy.  Monoclonal antibody 
anti-B4 conjugated with blocked ricin (ImmunoGen), Anti-B4-bR, NSC-639185.

Arm II:  No Adjuvant Therapy.

Grossbard ML, Niedzwiecki D, Nadler LM, et al.: Anti-B4-blocked ricin (Anti-B4-bR) adjuvant therapy post-autologous bone marrow transplant (ABMT) (CALGB 9254): a phase III intergroup study. [Abstract] Proceedings of the American Society of Clinical Oncology 17: A8, 3a, 1998.

Trial Contact Information

Trial Lead Organizations

Cancer and Leukemia Group B

Michael Grossbard, MD, Protocol chair		Ph: 212-523-5419 Email: mgrossbard@chpnet.org

Eastern Cooperative Oncology Group

Andrew Pecora, MD, FACP, Protocol chair		Ph: 201-996-5814 Email: APecora@humed.com