Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Epratuzumab in Treating Patients With Non-Hodgkin's Lymphoma

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Closed 18 and over NCI, Pharmaceutical / Industry UCLA-0009041 IM-T-hLL2-07, UCLA-BB-IND-7124, NCI-G01-2004, NCT00022685

Objectives

1. Determine the safety of epratuzumab in patients with rituximab-refractory low-grade follicular B-cell non-Hodgkin's lymphoma.
2. Confirm the convenient administration of this drug in this patient population.
3. Determine the efficacy of this drug in terms of objective response rate in these patients.
4. Determine the duration of response and time to progression in patients treated with this drug.

Entry Criteria

Disease Characteristics:

• Histologically confirmed low-grade follicular B-cell non-Hodgkin's lymphoma
  • Small cleaved cell

    OR

  • Mixed cell



• The following are ineligible:
  • Primary CNS lymphoma
  • HIV lymphoma
  • Richter's lymphoma
  • Bulky disease (any single mass greater than 10 cm)
  • Pleural effusion with positive cytology for lymphoma



• Failed prior standard chemotherapy for non-Hodgkin's lymphoma



• Refractory to at least 1 prior treatment with rituximab
  • Disease progression or failure to achieve objective response within 6 months of beginning rituximab therapy



• At least 1 bidimensionally measurable lesion
  • At least 1.5 cm by CT scan

 [Note: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.]

Prior/Concurrent Therapy:

Biologic therapy:

• See Disease Characteristics
• At least 12 weeks since prior autologous stem cell transplantation
• No prior radioimmunoconjugate therapies

Chemotherapy:

• See Disease Characteristics
• No more than 4 prior treatment regimens
• At least 4 weeks since prior chemotherapy

Endocrine therapy:

• At least 2 weeks since prior corticosteroids
• No concurrent steroids

Radiotherapy:

• See Biologic therapy
• At least 4 weeks since prior radiotherapy to target lesion

Surgery:

• At least 4 weeks since prior major surgery unless recovered

Other:

• At least 4 weeks since prior experimental therapies
• No other concurrent investigational or therapeutic agents

Patient Characteristics:

Age:

• 18 and over

Performance status:

• Karnofsky 60-100%
• ECOG 0-2

Life expectancy:

• At least 4 months

Hematopoietic:

• Absolute granulocyte count at least 1,500/mm³
• Platelet count at least 50,000/mm³
• Hemoglobin at least 8 g/dL
• Transfusion independent

Hepatic:

• Bilirubin no greater than 1.5 times upper limit of normal (ULN)*
• Alkaline phosphatase less than 2 times ULN*
• AST less than 2 times ULN*

 [Note: *Unless lymphoma-related]

Renal:

• Creatinine no greater than 1.5 times ULN unless lymphoma-related

Other:

• No other malignancy within the past 5 years except squamous or basal cell skin cancer or carcinoma in situ of the cervix
• No other serious condition or infection that would preclude study participation
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 3 months after study participation

Expected Enrollment

Approximately 30-100 patients will be accrued for this study.

Outline

This is a multicenter study.

Patients receive epratuzumab IV over 15-60 minutes on days 1, 8, 15, and 22.

Patients are followed every 8 weeks for 10 months and then every 3 months for up to 4 years.

Trial Contact Information

Trial Lead Organizations

Jonsson Comprehensive Cancer Center at UCLA

Peter Rosen, MD, Protocol chair		Ph: 310-825-5268; 888-798-0719

Registry Information
Official Title		A Phase III Clinical Trial of Immunotherapy with Humanized LL2 IgG (epratuzumab) in Patients with Low-Grade Follicular, B-Cell Non-Hodgkin's Lymphoma Refractory to Rituxan (rituximab)
Trial Start Date		2001-09-10
Registered in ClinicalTrials.gov		NCT00022685
Date Submitted to PDQ		2001-07-03
Information Last Verified		2003-04-23
NCI Grant/Contract Number		P30-CA16042