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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00042913
Other study ID # CDR0000069484
Secondary ID UCLA-0201056AMGE
Status Active, not recruiting
Phase Phase 2
First received August 5, 2002
Last updated December 18, 2013
Start date May 2002

Study information

Verified date September 2003
Source National Cancer Institute (NCI)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

RATIONALE: Monoclonal antibodies such as epratuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.

PURPOSE: Randomized phase II trial to study the effectiveness of epratuzumab in treating patients who have non-Hodgkin's lymphoma.


Description:

OBJECTIVES:

- Determine the response rate of patients with diffuse large B-cell non-Hodgkin's lymphoma treated with epratuzumab.

- Determine the toxicity of this drug in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 3 treatment arms.

- Arm I: Patients receive low-dose epratuzumab IV over 1 hour once weekly for 4 weeks.

- Arm II: Patients receive low-dose epratuzumab IV over 1 hour once weekly for 8 weeks.

- Arm III: Patients receive high-dose epratuzumab IV over 1 hour once weekly for 4 weeks.

Patients are followed every 3 months for 2 years and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 150 patients (50 per treatment arm) will be accrued for this study.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility DISEASE CHARACTERISTICS:

- Histologically confirmed diffuse large B-cell non-Hodgkin's lymphoma (NHL)

- Relapsed or refractory after at least 1 regimen of standard therapy

- Prior therapy may include high-dose chemotherapy with autologous stem cell transplantation (ASCT) or immunotherapy

- Bidimensionally measurable disease

- At least 1 lesion at least 1.5 cm by CT scan

- No primary or secondary CNS lymphoma

- No HIV-related lymphoma

- No known or suspected transformed lymphoma (prior or concurrent)

- No bulky disease (i.e., any single mass greater than 10.0 cm)

- No pleural effusion with positive cytology for lymphoma

- Most recent pathology specimen available for collection

- No rapid disease progression or symptoms that indicate disease progression requiring rapid intervention within the past 2 weeks (e.g., severe shortness of breath, severe pain, or gastrointestinal or genitourinary obstruction)

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- ECOG 0-2

Life expectancy

- At least 4 months

Hematopoietic

- Absolute neutrophil count at least 1,000/mm3

- Platelet count at least 50,000/mm3 (transfusion independent)

- Hemoglobin at least 9.0 g/dL

Hepatic

- Bilirubin no greater than 2 times upper limit of normal (ULN)

- AST and ALT less than 5 times ULN

- Hepatitis B surface antigen negative

- Hepatitis C negative

Renal

- Creatinine no greater than 2 times ULN

Other

- HIV negative

- No other primary malignancy within the past 3 years except squamous cell or basal cell skin cancer, carcinoma in situ of the cervix, or stage I prostate cancer

- No other serious nonmalignant condition that would preclude study

- No serious infection

- No known human antichimeric antibodies or human antihuman antibody positivity

- No type 1 hypersensitivity or anaphylactic reactions to murine proteins

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for at least 6 months after study

PRIOR CONCURRENT THERAPY:

Biologic therapy

- See Disease Characteristics

- At least 4 weeks since prior immunotherapy (unless clearly progressing)

- At least 12 weeks since prior ASCT

Chemotherapy

- See Disease Characteristics

- At least 4 weeks since prior chemotherapy (unless clearly progressing)

Endocrine therapy

- Not specified

Radiotherapy

- No prior radioimmunotherapy

Surgery

- At least 4 weeks since prior major surgery (unless patient has fully recovered)

Other

- At least 30 days since prior enrollment in clinical trials involving investigational devices or drugs

- No concurrent enrollment in other clinical trials involving investigational devices or drugs

- No concurrent investigational agents for disease other than NHL

Study Design

Allocation: Randomized, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Biological:
epratuzumab


Locations

Country Name City State
United States Jonsson Comprehensive Cancer Center, UCLA Los Angeles California

Sponsors (2)

Lead Sponsor Collaborator
Jonsson Comprehensive Cancer Center National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

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