Non-Hodgkin's LymphomaPhase 2NCT00051025
Phase II Study of ONTAK in Previously Treated Patients With Low-grade Non-Hodgkin's Lymphoma (NHL)
A Phase 2 study testing ONTAK in people with Non-Hodgkin's Lymphoma and Lymphoma, B-cell, run by Eisai Inc. at 2 sites in United States.
Trial summary
The purpose of this study is to look at the safety and effectiveness of ONTAK in previously treated patients with NHL. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Hodgkin's Lymphoma, Lymphoma, B-cell, Lymphoma, Low-grade
- What is being tested?
- ONTAK
- How many people
- 9 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2000to Sep 2006
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Pathological diagnosis of low-grade (indolent), B-cell, non-Hodgkin's lymphoma.
- Positive expression for CD25 of tumor cells in a lymph node biopsy as defined by greater than 20% of malignant cells staining for CD25 by standardized immunohistochemical assay.
- Modified Ann Arbor Stage I, II, III or IV.
- Patients must have received at least two but no more than five prior therapies. One prior therapy must have been cytotoxic chemotherapy and one prior therapy must have been monoclonal antibody therapy. Combination chemotherapy, including regimens used prior to bone marrow transplantation, will count as a single therapy for purposes of eligibility.
- Patients must have bidimensionally measurable disease.
- Patients must be 18 years of age or older.
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- An ECOG performance status of 0, 1, or 2.
- Acceptable organ function defined as follows:
- absolute neutrophil count (ANC) > or = to 1,000/mm3, platelet count > or = to 50,000/mm3, Hemoglobin > or = to 8 g/dL;
- Bilirubin < or = to 1.5 times the upper limit of normal (ULN);
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < or = to 1.5 times the upper limit of normal;
- Serum creatinine <1.8mg/dL;
- Serum albumin > or = to 3.0 g/dL.
- New York Heart Association classification of I or II and no history of poorly controlled hypertension.
- Must be free of serious concurrent illness.
- Female patients must meet the following criteria:
- If the patient is a female of childbearing potential, she must have negative serum beta human chorionic gonadotropin (B-hCG) pregnancy test within seven days prior to study entry and must have used an effective means of contraception or have been sexually abstinent for at least four weeks prior to the negative serum pregnancy test and through to study entry.
- Female patients of childbearing potential must agree to practice an effective method of birth control during the entire treatment period and for at least three weeks after their last treatment on protocol.
Who cannot join
- Patients with cutaneous T-cell lymphoma.
- Patients previously treated with ONTAK (DAB389lL-2) or DAB486IL-2.
- Inability to comply with protocol requirements for this study.
- Pregnant women or lactating women who are breast feeding or women planning to become pregnant during the treatment period or three weeks after their last treatment on protocol.
- Serious intercurrent medical illnesses or active infections requiring parenteral antibiotics, which would interfere with the ability of the patient to carry out the treatment program.
- Sero-positive for human immunodeficiency virus (HIV) antibody. History of ongoing Hepatitis B or Hepatitis C infection.
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- Another malignancy or history of another cancer with less than five disease-free years (other than resected basal or squamous cell skin cancers or in situ cervical cancer).
- Patients with a known hypersensitivity to ONTAK or any of its components: diphtheria toxin, interleukin-2, or excipients.
- Any investigational agents within one month prior to study entry.
- Prior radiation therapy within four weeks of enrollment or to the only site of evaluable disease.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Central Baptist Hospital
Lexington, Kentucky, 40503
Hematology and Oncology Services
Metairie, Louisiana, 70006
About this study
Official title: A Randomized, Multicenter, Phase II Evaluation of ONTAK (Denileukin Diftitox) in Patients With Previously Treated, Indolent, B-Cell, Non-Hodgkin's Lymphoma
The purpose of this study is to look at the safety and effectiveness of ONTAK in previously treated patients with NHL.
- Being tested
- ONTAK
- Medical subject headings
- Lymphoma, Non-Hodgkin, Lymphoma, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ONTAKDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Clinical Response: Complete Response (CR) or Partial Response (PR) at Week 24, or, in the Event of Lengthened Cycle Intervals, at the End of Cycle 8.
Complete response: achievement of a complete regression for >4 weeks of all palpable and x-ray demonstrable disease and bone marrow disease. Partial response: response to therapy with a 75% reduction in the greatest diameters of the measurable lesions for >4 weeks and had indeterminate bone marrow biopsy
Measured: 24 Weeks
Secondary outcomes (2)
Duration of Response
The duration of response was defined as the time interval from start of the first response (CR or PR) to the time of documented disease progression.
Measured: From beginning of response to time of relapse
Time-to-Treatment Failure
Measured: From start of first treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2003 (estimated)
- Study startMay 2000
- Primary completionJan 2001
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Non-Hodgkin's LymphomaStudies of the same condition, open and under way.
- More trials run by Eisai Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Elyane Lombardy, M.D., Study director, Ligand Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00051025
- Sponsor's protocol ID
- L4389-30
- Status last verified
- Jul 2012
- First submitted
- 31 Dec 2002
- Last updated
- 13 Jul 2012
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multicenter, Phase II Evaluation of ONTAK (Denileukin Diftitox) in Patients With Previously Treated, Indolent, B-Cell, Non-Hodgkin's Lymphoma
- ClinicalTrials.gov ID
- NCT00051025
- Acronym / sponsor ID
- L4389-30
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Eisai Inc.Industry (pharma, biotech, devices)
- Study start
- May 2000
- Primary completion
- Jan 2001 (actual)
- Study completion
- Sep 2006 (actual)
- First posted
- 3 Jan 2003 (estimated)
- Results
- Posted 3 Aug 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to look at the safety and effectiveness of ONTAK in previously treated patients with NHL.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Pathological diagnosis of low-grade (indolent), B-cell, non-Hodgkin's lymphoma.
- Positive expression for CD25 of tumor cells in a lymph node biopsy as defined by greater than 20% of malignant cells staining for CD25 by standardized immunohistochemical assay.
- Modified Ann Arbor Stage I, II, III or IV.
- Patients must have received at least two but no more than five prior therapies. One prior therapy must have been cytotoxic chemotherapy and one prior therapy must have been monoclonal antibody therapy. Combination chemotherapy, including regimens used prior to bone marrow transplantation, will count as a single therapy for purposes of eligibility.
- Patients must have bidimensionally measurable disease.
Key exclusion criteria (10 listed)
- Patients with cutaneous T-cell lymphoma.
- Patients previously treated with ONTAK (DAB389lL-2) or DAB486IL-2.
- Inability to comply with protocol requirements for this study.
- Pregnant women or lactating women who are breast feeding or women planning to become pregnant during the treatment period or three weeks after their last treatment on protocol.
- Serious intercurrent medical illnesses or active infections requiring parenteral antibiotics, which would interfere with the ability of the patient to carry out the treatment program.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ONTAK | Drug | – |
Primary outcome
Objective Clinical Response: Complete Response (CR) or Partial Response (PR) at Week 24, or, in the Event of Lengthened Cycle Intervals, at the End of Cycle 8.
Time frame: 24 Weeks
Complete response: achievement of a complete regression for >4 weeks of all palpable and x-ray demonstrable disease and bone marrow disease. Partial response: response to therapy with a 75% reduction in the greatest diameters of the measurable lesions for >4 weeks and had indeterminate bone marrow biopsy
2 secondary outcomes
Duration of Response
Time frame: From beginning of response to time of relapse
Time-to-Treatment Failure
Time frame: From start of first treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elyane Lombardy, M.D. study director
Ligand Pharmaceuticals
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ONTAK in people with Non-Hodgkin's Lymphoma and Lymphoma, B-cell, run by Eisai Inc. at 2 sites 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?
The sponsor lists 18 inclusion and 10 exclusion criteria. 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: finished, as of the sponsor's last update on 13 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 3 Aug 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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.
What does the primary outcome measure?
Objective Clinical Response: Complete Response (CR) or Partial Response (PR) at Week 24, or, in the Event of Lengthened Cycle Intervals, at the End of Cycle 8. (time frame: 24 Weeks). It is what the study was designed to measure, not a finding.
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 13 Jul 2012.