Lymphoma, B-CellPhase 2NCT00211276
A Study of ONTAK in Patients With Relapsed or Refractory, B-Cell Non Hodgkin's Lymphoma
A Phase 2 study testing ONTAK (denileukin diftitox) in people with Lymphoma, B-Cell, run by Eisai Inc. at 12 sites in United States.
Trial summary
The goal of this clinical research study is to find out if the study drug, ONTAK (denileukin diftitox), can shrink or slow the growth of B-cell non-Hodgkin's lymphoma (NHL) in patients whose disease has not responded to prior treatments, or has relapsed after an initial response to prior treatments. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, B-Cell
- What is being tested?
- ONTAK (denileukin diftitox)
- How many people
- 50 participants
- Where
- 12 sitesUnited States
- Study dates
- Mar 2005to Feb 2007
- 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
Who may be able to join
- Relapsed or refractory B-Cell NHL
- Histological documentation of diffuse large B-cell lymphoma, follicular lymphoma (grade 1, 2, or 3), small lymphocytic lymphoma or transformed B-Cell lymphoma.
- Bi-dimensionally measurable disease with at least one lymph node or tumor mass measuring > or equal to 4 cm2
- ECOG performance status less than or equal to 2.
- Failure to respond or progression of disease after 2 or more prior treatment regimens; this may include high dose therapy (HDT) with stem cell transplantation (SCT). Patients with prior HDT plus SCT will be considered as having "diminished bone marrow reserve"
- At least 18 years of age
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- At least 3 weeks from last anti-lymphoma therapy
- Mild to moderate cytopenia defined as any of the following:
- ANC > or equal to 1,000/microL and < 1,500/microL off growth factors
- WBC counts > or equal to 2,000/microL and < 4,000/microL off growth factors or
- Platelet count > or equal to 40,000/microL (25,000/microL if thrombocytopenia is secondary to marrow involvement by lymphoma) and < 150,000/microL.
- Acceptable organ function defined as all of the following:
- Bilirubin < or equal to 1.5 times the upper limit of normal (ULN)
- SGOT (AST) and SGPT (ALT) < or equal to 2 times the ULN.
- Serum creatinine < 2 times ULN.
- Serum albumin > or equal to 3.0 g/dL
- Female patient of childbearing potential must have a negative pregnancy test within seven days prior to study drug administration, and must agree to use an effective means of contraception throughout the study.
- Life expectancy of at least 16 weeks.
- Patients must have reviewed, signed and dated a witnessed informed consent document that has been approved by the IRB of each participating center.
Who cannot join
- Less than 6 months from prior allogeneic stem cell transplant and/or patient with active graft versus host disease (GVHD) Grade > or equal to 2.
- Prior history of veno-occlusive disease of the liver.
- Inability to comply with protocol requirements of this study for intravenous administration of ONTAK.
- Pregnant women or lactating women who are breastfeeding or women planning to become pregnant during the treatment period.
- Serious intercurrent medical illnesses or active infections that, in the investigators opinion, might interfere with the interpretation of the study safety data or compromise the patients ability to carry out the treatment program.
- Known history of seropositivity for HIV or chronic hepatitis (testing for HIV is not required).
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- Known hypersensitivity to ONTAK or any of its components: diptheria toxin, interleukin-2 or excipients.
- Experimental therapy within 4 weeks prior to study entry.
- Patients diagnosed with congestive heart failure, NYHA Class III or IV, ventricular tachycardia, fibrillation, or a history of myocardial infarction in the 12 months prior to study entry.
- Any prior radiation therapy within four weeks of enrollment, or prior radiation therapy to the only site of evaluable disease unless disease progression has occurred in that site.
- Patients on concurrent corticosteroids as treatment for NHL. The use of tapering doses or low doses of corticosteroids for resolving GVHD, or the use of corticosteroids as premedication prior to ONTAK or as a transient treatment for hypersensitivity reactions is permitted as necessary.
- History of prior malignancy within the preceding 5 years, except for successfully treated cervical carcinoma in situ or basal cell carcinoma.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Emory University
Atlanta, Georgia, 30306
Tower Cancer Research Foundation
Beverly Hills, California, 90211-1850
Roswell Park Cancer Institute
Buffalo, New York, 14263
Rush University Medical Center
Chicago, Illinois, 60612
Case Comprehensive Cancer Center
Cleveland, Ohio, 44106
Pacific Coast Hematology/Oncology
Fountain Valley, California, 92708
Hackensack University Medical Center
Hackensack, New Jersey, 07601
University of California, Los Angeles
Los Angeles, California, 90095
St. Vincent's Comprehensive Cancer Center
New York, New York, 10011
The Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, 15224
Siouxland Hematology-Oncology
Sioux City, Iowa, 51101-1733
Washington University Siteman Cancer Center
St Louis, Missouri, 63110
About this study
Official title: A Phase II Multicenter Study of ONTAK in Patients With Relapsed or Refractory, B-Cell Non-Hodgkins Lymphoma.
The goal of this clinical research study is to find out if the study drug, ONTAK (denileukin diftitox), can shrink or slow the growth of B-cell non-Hodgkin's lymphoma (NHL) in patients whose disease has not responded to prior treatments, or has relapsed after an initial response to prior treatments. The safety of treatment with ONTAK will also be studied. The hypothesis is that patients with relapsed or refractory B-cell NHL and mild to moderate myelosuppression treated with ONTAK at a new dosing regimen will respond sufficiently to warrant further study.
- Conditions
- Lymphoma, B-Cell
- Being tested
- ONTAK (denileukin diftitox)
- Medical subject headings
- Lymphoma, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ONTAK (denileukin diftitox)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Response will be evaluated by CT or MRI scans at baseline, every 8 weeks while on therapy, and every 3 months after therapy, using standard response criteria defined by Cheson et al.
Secondary outcomes (1)
Safety data will include laboratory, history and physical, and adverse events reports for both local and systemic signs or symptoms of study patients. Survival at one year post-therapy will also be assessed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startMar 2005
- Primary completionJan 2007
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, B-CellStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eisai Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Myron Czuczman, MD, Principal investigator, Roswell Park Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00211276
- Sponsor's protocol ID
- #123
- Status last verified
- Mar 2011
- First submitted
- 13 Sep 2005
- Last updated
- 14 Mar 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Multicenter Study of ONTAK in Patients With Relapsed or Refractory, B-Cell Non-Hodgkins Lymphoma.
- ClinicalTrials.gov ID
- NCT00211276
- Acronym / sponsor ID
- #123
- Conditions
- Lymphoma, B-Cell
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Eisai Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2005
- Primary completion
- Jan 2007 (actual)
- Study completion
- Feb 2007 (actual)
- First posted
- 21 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical research study is to find out if the study drug, ONTAK (denileukin diftitox), can shrink or slow the growth of B-cell non-Hodgkin's lymphoma (NHL) in patients whose disease has not responded to prior treatments, or has relapsed after an initial response to prior treatments. The safety of treatment with ONTAK will also be studied. The hypothesis is that patients with relapsed or refractory B-cell NHL and mild to moderate myelosuppression treated with ONTAK at a new dosing regimen will respond sufficiently to warrant further study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Relapsed or refractory B-Cell NHL
- Histological documentation of diffuse large B-cell lymphoma, follicular lymphoma (grade 1, 2, or 3), small lymphocytic lymphoma or transformed B-Cell lymphoma.
- Bi-dimensionally measurable disease with at least one lymph node or tumor mass measuring > or equal to 4 cm2
- ECOG performance status less than or equal to 2.
- Failure to respond or progression of disease after 2 or more prior treatment regimens; this may include high dose therapy (HDT) with stem cell transplantation (SCT). Patients with prior HDT plus SCT will be considered as having "diminished bone marrow reserve"
Key exclusion criteria (12 listed)
- Less than 6 months from prior allogeneic stem cell transplant and/or patient with active graft versus host disease (GVHD) Grade > or equal to 2.
- Prior history of veno-occlusive disease of the liver.
- Inability to comply with protocol requirements of this study for intravenous administration of ONTAK.
- Pregnant women or lactating women who are breastfeeding or women planning to become pregnant during the treatment period.
- Serious intercurrent medical illnesses or active infections that, in the investigators opinion, might interfere with the interpretation of the study safety data or compromise the patients ability 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 (denileukin diftitox) | Drug | – |
Primary outcome
Disease Response will be evaluated by CT or MRI scans at baseline, every 8 weeks while on therapy, and every 3 months after therapy, using standard response criteria defined by Cheson et al.
1 secondary outcome
Safety data will include laboratory, history and physical, and adverse events reports for both local and systemic signs or symptoms of study patients. Survival at one year post-therapy will also be assessed.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2012.
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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.
Myron Czuczman, MD principal investigator
Roswell Park Cancer Institute
12 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 (denileukin diftitox) in people with Lymphoma, B-Cell, run by Eisai Inc. at 12 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 19 inclusion and 12 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 14 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Disease Response will be evaluated by CT or MRI scans at baseline, every 8 weeks while on therapy, and every 3 months after therapy, using standard response criteria defined by Cheson et al.. 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 14 Mar 2012.