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LymphomaPhase 3NCT00022685

Epratuzumab in Treating Patients With Non-Hodgkin's Lymphoma

A Phase 3 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 The sponsor has not verified this record for over two years, so it may be out of date.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: Phase III trial to determine the effectiveness of epratuzumab in treating patients who have low-grade non-Hodgkin's lymphoma that has not… 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
Sep 2001to not given
Phase
Phase 3
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 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.

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/mm^3
  • Platelet count at least 50,000/mm^3
  • 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

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

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 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)

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: Phase III trial to determine the effectiveness of epratuzumab in treating patients who have low-grade non-Hodgkin's lymphoma that has not responded to chemotherapy or rituximab.

Read the detailed description

OBJECTIVES:

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

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.

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

Conditions
Lymphoma
Being tested
epratuzumab
Keywords
recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma
Medical subject headings
Lymphoma, Lymphoma, Follicular

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 startSep 2001

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 3
Primary purpose
Treatment
Masking
None (open label)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00022685
Sponsor's protocol ID
CDR0000068842
Other IDs
UCLA-0009041, IM-T-hLL2-07, UCLA-BB-IND-7124, NCI-G01-2004
Status last verified
Apr 2003
First submitted
10 Aug 2001
Last updated
19 Dec 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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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