LymphomaPhase 2NCT00073957
Y 90 Ibritumomab Tiuxetan &Rituximab Relapsed or Refractory Diffuse Large B-Cell Non-Hodgkin's Lymphoma
A Phase 2 study testing rituximab, cytarabine and liposomal cytarabine in people with Lymphoma, run by Beth Israel Deaconess Medical Center at 2 sites in United States.
Trial summary
RATIONALE: Monoclonal antibodies, such as yttrium Y 90 ibritumomab tiuxetan and rituximab, can locate cancer cells and either kill them or deliver radioactive cancer-killing substances to them without harming normal cells. Combining yttrium Y 90 ibritumomab tiuxetan with rituximab may kill more cancer cells. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Lymphoma
- What is being tested?
- rituximab, cytarabine and liposomal cytarabine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2003to 1 Jan 2012
- 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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed diffuse large B-cell non-Hodgkin's lymphoma, including any of the following:
- B-cell diffuse large cell variant
- Immunoblastic
- Mediastinal (thymic) large cell
- T-cell/histiocyte-rich
- Anaplastic large B-cell
- Intravascular large B-cell
- Lymphomatoid granulomatosis
- Relapsed or refractory disease after at least 1 prior chemotherapy regimen and requires further treatment
- Relapsed disease, defined as the following:
- Appearance of any new lesion OR increase of at least 50% in the size of a previously involved site
- 50% increase in greatest diameter of any previously identified node greater than 1 cm in the short axis OR in the sum of the perpendicular diameter (SPD) of more than 1 node
- Progressive disease, defined as the following:
- 50% increase from nadir in the SPD of any previously identified abnormal node
- Appearance of any new lesion during or at the end of therapy
- CD20-positive disease by immunohistochemistry
- Bidimensionally measurable disease
- At least 1 lesion at least 2.0 cm by CT scan
- Less than 25% bone marrow involvement by lymphoma
- No transformed lymphoma from indolent to aggressive
- No HIV- or AIDS-related lymphoma
- No hypocellular bone marrow
- No marked reduction in bone marrow precursors of 1 or more cell lines (e.g., granulocytic, megakaryocytic, or erythroid)
- No CNS lymphoma
- Ineligible for myeloablative therapy OR refused transplantation
- Ineligible for any other open yttrium Y 90 ibritumomab tiuxetan investigational protocols
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- WHO 0-2
Life expectancy
- At least 3 months
Hematopoietic
- Absolute neutrophil count at least 1,500/mm^3
- Lymphocyte count no greater than 5,000/mm^3 (for patients with small lymphocytic lymphoma)
- Platelet count at least 100,000/mm^3
Hepatic
- Bilirubin no greater than 2.0 mg/dL
Renal
- Creatinine no greater than 2.0 mg/dL
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 1 year after study participation
- No concurrent serious nonmalignant disease or infection that would preclude study participation
- No human antimurine antibody reactivity
PRIOR CONCURRENT THERAPY:
Biologic therapy
- See Disease Characteristics
- No prior autologous bone marrow transplantation
- No prior peripheral blood stem cell rescue
- No prior failed stem cell collection
- Prior rituximab within the past 90 days allowed provided patient has fludeoxyglucose-avid disease that is also indium In 111 ibritumomab tiuxetan-avid disease in at least 1 lesion
- More than 2 weeks since prior filgrastim (G-CSF) or sargramostim (GM-CSF)
Chemotherapy
- See Disease Characteristics
Endocrine therapy
- Not specified
Radiotherapy
- No prior radioimmunotherapy
- No prior external beam radiotherapy (involved field or regional) to more than 25% of active bone marrow
Surgery
- More than 4 weeks since prior major surgery (except diagnostic surgery)
Other
- Recovered from all prior therapy
- More than 4 weeks since prior therapy for lymphoma
- More than 8 weeks since prior phase II investigational drugs
- No other concurrent antineoplastic therapy
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Fletcher Allen Health Care - Medical Center Campus
Burlington, Vermont, 05401
About this study
Official title: Zevalin And Rituxan For The Treatment Of Relapsed Or Refractory Diffuse Large B-Cell Non-Hodgkin's Lymphoma
RATIONALE: Monoclonal antibodies, such as yttrium Y 90 ibritumomab tiuxetan and rituximab, can locate cancer cells and either kill them or deliver radioactive cancer-killing substances to them without harming normal cells. Combining yttrium Y 90 ibritumomab tiuxetan with rituximab may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of combining yttrium Y 90 Ibritumomab tiuxetan with rituximab in treating patients who have relapsed or refractory diffuse large B-cell non-Hodgkin's lymphoma.
Read the detailed description
OBJECTIVES:
- Determine the best overall response in patients with relapsed or refractory diffuse large B-cell non-Hodgkin's lymphoma treated with yttrium Y 90 ibritumomab tiuxetan and rituximab.
- Determine the event-free survival of patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
OUTLINE: This is an open-label, multicenter study.
- Radioimmunotherapy: Patients receive indium In 111 ibritumomab tiuxetan IV over 10 minutes on day 1 (for imaging only); yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 8; and rituximab IV over 3-4 hours on days 1, 8, 15, 22, 29, and 36.
- CNS ( central nervous system)prophylaxis: Patients receive CNS prophylaxis comprising intrathecal (IT) methotrexate or IT cytarabine on days 15, 22, 29, and 36 OR IT cytarabine (liposomal) on days 15 and 29.
- Maintenance rituximab: Patients are assessed for response at week 14. Beginning at month 6, patients with stable or responding disease receive maintenance therapy comprising rituximab IV over 3-4 hours once weekly for 4 weeks. Maintenance therapy repeats every 6 months for 2 years (total of 4 courses) in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years and then every 6 months for 2 years.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 2 years.
- Conditions
- Lymphoma
- Being tested
- rituximab, cytarabine, liposomal cytarabine, yttrium Y 90 ibritumomab tiuxetan
- Keywords
- recurrent adult diffuse large cell lymphoma, recurrent adult immunoblastic large cell lymphoma, anaplastic large cell lymphoma
- Medical subject headings
- Lymphoma, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Large-Cell, Immunoblastic, Lymphoma, Large-Cell, Anaplastic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rituximabBiological
Also called Rituxan
cytarabineDrug
Also called cytosine arabinoside
to be used for CNS prophylaxis
liposomal cytarabineDrug
Also called Depocyte
to be used as CNS prophylaxis
yttrium Y 90 ibritumomab tiuxetanRadiation
Also called Zevalin
| Study group | Role | What they receive |
|---|---|---|
| Y-90 Ibritumomab Tiuxetan | Experimental | Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab and central nervous system prophylaxis with Cytarabine or liposomal cytarabine Receives: Biological: rituximab; Drug: cytarabine; Drug: liposomal cytarabine; Radiation: yttrium Y 90 ibritumomab tiuxetan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response Rate = Complete and Partial Response at 12 Weeks.
Definition Nodal Masses Spleen, Liver Bone Marrow CR Disappearance of all evidence of disease Partial response Regression and no new sites ≥ 50% decrease in sum of the perpendicular dimension of up to 6 largest dominant masses; no increase in size of other nodes Stable disease Failure to attain CR/PR or Progressive disease or Relapsed disease : the appearance of any new lesion or the (a) FDG-avid or PET positive prior to therapy; PET positive at prior sites of disease and no new sites on CT or PET Any new lesion or increase by ≥ 50% of previously involved sites from nadir Appearance of a new lesion(s) > 1.5 cm in any axis, ≥ 50% increase in SPD of more than one node, or ≥ 50% increase in longest diameter of a previously identified node > 1 cm in short axis > 50% increase from nadir in the SPD of any previous lesions New or recurrent involvement Lesions PET positive if FDG-avid lymphoma or PET positive prior to therapy
Measured: 12 weeks
Best Response
This data is the best overall response achieved by patients by the 12 month period.
Measured: 12 months
Secondary outcomes (1)
Event Free Survival
the median time point at which a participants experienced and event or toxicity or progression
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2003 (estimated)
- Study startDec 2003
- Primary completion1 Jan 2012
- Study completion1 Jan 2012
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 LymphomaStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- Standard Phase 2
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robin Joyce, Beth Israel Deaconess Medical Center
- Investigators
- Robin Joyce, MD, Study chair, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00073957
- Sponsor's protocol ID
- 2003P000182
- Other IDs
- CDR0000341437
- Status last verified
- Dec 2017
- First submitted
- 10 Dec 2003
- Last updated
- 23 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zevalin And Rituxan For The Treatment Of Relapsed Or Refractory Diffuse Large B-Cell Non-Hodgkin's Lymphoma
- ClinicalTrials.gov ID
- NCT00073957
- Acronym / sponsor ID
- 2003P000182
- Conditions
- Lymphoma
- Keywords
- recurrent adult diffuse large cell lymphoma, recurrent adult immunoblastic large cell lymphoma, anaplastic large cell lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- Dec 2003 (actual)
- Primary completion
- 1 Jan 2012 (actual)
- Study completion
- 1 Jan 2012 (actual)
- First posted
- 11 Dec 2003 (estimated)
- Results
- Posted 23 Jan 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Monoclonal antibodies, such as yttrium Y 90 ibritumomab tiuxetan and rituximab, can locate cancer cells and either kill them or deliver radioactive cancer-killing substances to them without harming normal cells. Combining yttrium Y 90 ibritumomab tiuxetan with rituximab may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of combining yttrium Y 90 Ibritumomab tiuxetan with rituximab in treating patients who have relapsed or refractory diffuse large B-cell non-Hodgkin's lymphoma.
Detailed description
OBJECTIVES:
- Determine the best overall response in patients with relapsed or refractory diffuse large B-cell non-Hodgkin's lymphoma treated with yttrium Y 90 ibritumomab tiuxetan and rituximab.
- Determine the event-free survival of patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
OUTLINE: This is an open-label, multicenter study.
- Radioimmunotherapy: Patients receive indium In 111 ibritumomab tiuxetan IV over 10 minutes on day 1 (for imaging only); yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 8; and rituximab IV over 3-4 hours on days 1, 8, 15, 22, 29, and 36.
- CNS ( central nervous system)prophylaxis: Patients receive CNS prophylaxis comprising intrathecal (IT) methotrexate or IT cytarabine on days 15, 22, 29, and 36 OR IT cytarabine (liposomal) on days 15 and 29.
- Maintenance rituximab: Patients are assessed for response at week 14. Beginning at month 6, patients with stable or responding disease receive maintenance therapy comprising rituximab IV over 3-4 hours once weekly for 4 weeks. Maintenance therapy repeats every 6 months for 2 years (total of 4 courses) in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years and then every 6 months for 2 years.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Standard Phase 2
| Arm | Type | Receives |
|---|---|---|
| Y-90 Ibritumomab Tiuxetan | Experimental | Biological: rituximab, Drug: cytarabine, Drug: liposomal cytarabine, Radiation: yttrium Y 90 ibritumomab tiuxetanYttrium Y 90 Ibritumomab Tiuxetan and Rituximab and central nervous system prophylaxis with Cytarabine or liposomal cytarabine |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| rituximabAlso: Rituxan | Biological | Y-90 Ibritumomab Tiuxetan |
| cytarabineAlso: cytosine arabinosideto be used for CNS prophylaxis | Drug | Y-90 Ibritumomab Tiuxetan |
| liposomal cytarabineAlso: Depocyteto be used as CNS prophylaxis | Drug | Y-90 Ibritumomab Tiuxetan |
| yttrium Y 90 ibritumomab tiuxetanAlso: Zevalin | Radiation | Y-90 Ibritumomab Tiuxetan |
Primary outcome
Response Rate = Complete and Partial Response at 12 Weeks.
Time frame: 12 weeks
Definition Nodal Masses Spleen, Liver Bone Marrow CR Disappearance of all evidence of disease Partial response Regression and no new sites ≥ 50% decrease in sum of the perpendicular dimension of up to 6 largest dominant masses; no increase in size of other nodes Stable disease Failure to attain CR/PR or Progressive disease or Relapsed disease : the appearance of any new lesion or the (a) FDG-avid or PET positive prior to therapy; PET positive at prior sites of disease and no new sites on CT or PET Any new lesion or increase by ≥ 50% of previously involved sites from nadir Appearance of a new lesion(s) > 1.5 cm in any axis, ≥ 50% increase in SPD of more than one node, or ≥ 50% increase in longest diameter of a previously identified node > 1 cm in short axis > 50% increase from nadir in the SPD of any previous lesions New or recurrent involvement Lesions PET positive if FDG-avid lymphoma or PET positive prior to therapy
Best Response
Time frame: 12 months
This data is the best overall response achieved by patients by the 12 month period.
1 secondary outcome
Event Free Survival
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Robin Joyce, MD study chair
Beth Israel Deaconess Medical Center
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 rituximab, cytarabine and liposomal cytarabine in people with Lymphoma, run by Beth Israel Deaconess Medical Center 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?
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 23 Jan 2018. 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 23 Jan 2018). 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?
Response Rate = Complete and Partial Response at 12 Weeks. (time frame: 12 weeks). The study lists 2 primary outcomes in all. 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 23 Jan 2018.