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LymphomaPhase 2NCT00042913

Epratuzumab in Treating Patients With Non-Hodgkin's Lymphoma

A Phase 2 study testing epratuzumab in people with Lymphoma, run by Jonsson Comprehensive Cancer Center at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lymphoma
What is being tested?
epratuzumab
How many people
Not given
Where
1 siteUnited States
Study dates
May 2002to not given
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Jonsson Comprehensive Cancer Center, UCLA

    Los Angeles, California, 90095-1781

Other trials in United States

About this study

Official title: A Phase 2 Open Label, Randomized, Dose And Schedule Finding, Clinical Trial Of Immunotherapy With AMG 412 In Subjects With Diffuse Large B-Cell Non-Hodgkin's Lymphoma

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.

Read the detailed 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.

Conditions
Lymphoma
Being tested
epratuzumab
Keywords
recurrent adult diffuse large cell lymphoma
Medical subject headings
Lymphoma, Lymphoma, Large B-Cell, Diffuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • epratuzumabBiological

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startMay 2002

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
IDs, dates and publications
ClinicalTrials.gov ID
NCT00042913
Sponsor's protocol ID
CDR0000069484
Other IDs
UCLA-0201056, AMGEN-AMG-412-159, NCI-G02-2094
Status last verified
Sep 2003
First submitted
5 Aug 2002
Last updated
19 Dec 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing epratuzumab in people with Lymphoma, run by Jonsson Comprehensive Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2013.

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