Primary Central Nervous System Non-Hodgkin LymphomaPhase 2NCT01973062
Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab in Primary Central Nervous System Non-Hodgkin Lymphoma
A Phase 2 study testing rituximab and yttrium Y 90 ibritumomab tiuxetan in people with Primary Central Nervous System Non-Hodgkin Lymphoma, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial summary
This phase II trial studies how well yttrium Y 90 ibritumomab tiuxetan and rituximab work in treating patients with recurrent or refractory primary central nervous system non-Hodgkin lymphoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Central Nervous System Non-Hodgkin Lymphoma
- What is being tested?
- rituximab and yttrium Y 90 ibritumomab tiuxetan
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Jun 2015
- 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
- Patients with histological diagnosis of recurrent or refractory primary central nervous system (CNS) lymphoma with at least 1 measurable gadolinium enhancing lesion on brain MRI scans
- Karnofsky performance status (KPS) >= 60
- Patients could not have had more than 3 prior therapy regimens for the treatment of PCNSL
- Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
- Platelets >= 100 x 10^9/L
- Hemoglobin (Hgb) > 10 g/dL
Show all 19Show fewer
- Serum total bilirubin =< 1.5 x upper limit of normal (ULN)
- Alanine aminotransferase (ALT) =< 3.0 x ULN
- Aspartate aminotransferase (AST) =< 3.0 x ULN
- Serum creatinine =< 1.5 x ULN
- Minimum interval since completion of radiation treatment is 12 weeks
- Minimum interval since last drug therapy:
- 3 weeks since the completion of non-cytotoxic agents
- 4 weeks since the completion of a non-nitrosourea-containing regimen
- 6 weeks since the completion of a nitrosourea-containing regimen
- Patients must have signed an approved informed consent and authorization permitting release of personal health information
- Patients are not on corticosteroids or on stable doses (less than 6 mg daily of dexamethasone) for more than 1 week before baseline imaging
- Patients with the potential for pregnancy or impregnating their partner must agree to follow acceptable birth control methods to avoid conception
- Patients must have no concurrent malignancy except curatively treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix and breast, adequately treated stage I or II cancer from which the patient is in complete remission; patients with other prior malignancies must be disease-free for >= three years
Who cannot join
- Pregnant or breast-feeding women
- Patients unwilling or unable to comply with the protocol
- Other concurrent severe and/or uncontrolled concomitant medical conditions (e.g. active infection, uncontrolled diabetes, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, or psychiatric illness, etc.) that could cause unacceptable safety risks or compromise compliance with the protocol
- Known diagnosis of human immunodeficiency virus (HIV) infection; prior radioimmunotherapy, prior myeloablative therapy with autologous bone marrow transplantation or peripheral stem cell rescue, and prior external beam radiation therapy to more than 25% of active bone marrow
- Patients who have received filgrastim (G-CSF) or sargramostim (GM-CSF) within 2 weeks before treatment or major surgery within the prior 4 weeks
Trial locations and contacts
1 site in 1 country.
United States1 site
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, 44195
About this study
Official title: Phase II Study of Radioimmunotherapy With Zevalin (Ibritumomab Tiuxetan) Therapy for Patients With Refractory or Relapsed Primary Central Nervous System Lymphoma (PCNSL)
This phase II trial studies how well yttrium Y 90 ibritumomab tiuxetan and rituximab work in treating patients with recurrent or refractory primary central nervous system non-Hodgkin lymphoma. Radiolabeled monoclonal antibodies, such as yttrium 90 ibritumomab tiuxetan, can find cancer cells and carry cancer-killing substances to them without harming normal cells. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving yttrium Y 90 ibritumomab tiuxetan with rituximab may kill more cancer cells.
Read the detailed description
PRIMARY OBJECTIVES:
- Determine the radiographic response proportion in patients with refractory or recurrent primary central nervous system lymphoma (PCNSL) to ibritumomab tiuxetan (yttrium Y 90 ibritumomab tiuxetan) when given as an intravenous infusion.
SECONDARY OBJECTIVES:
- Determine the progression free survival of patients treated with ibritumomab tiuxetan when given as an intravenous infusion.
II. Determine the overall survival of patients treated with ibritumomab tiuxetan when given as an intravenous infusion.
III. Establish the toxicity profile of ibritumomab tiuxetan in this patient population.
IV. Use positron emission tomography (PET)/magnetic resonance imaging (MRI) to map the distribution of Y-90 ibritumomab tiuxetan, and calculate the Gy delivered based on the activity found within tumor.
OUTLINE:
Patients receive rituximab intravenously (IV) on day 1. Within 7 to 9 days, patients receive rituximab IV and yttrium Y 90 ibritumomab tiuxetan IV in the absence of disease progression or unacceptable toxicity. Distribution and dose absorbed dose will be assessed on day 11. Quality of life will be assessed at screening, at day 1, 36, 92, and at each follow-up visit.
After completion of study treatment, patients are followed every 3-6 months for 2 years.
- Being tested
- rituximab, yttrium Y 90 ibritumomab tiuxetan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rituximabBiological
Also called IDEC-C2B8, IDEC-C2B8 monoclonal antibody, Mabthera, MOAB IDEC-C2B8
Given IV
yttrium Y 90 ibritumomab tiuxetanRadiation
Also called 90Y ibritumomab tiuxetan, IDEC Y2B8, Y90 Zevalin, Y90-labeled ibritumomab tiuxetan
Given IV
| Study group | Role | What they receive |
|---|---|---|
| rituximab and yttrium Y 90 ibritumomab tiuxetan | Experimental | Patients receive rituximab IV on day 1. Within 7 to 9 days, patients receive rituximab IV and yttrium Y 90 ibritumomab tiuxetan IV in the absence of disease progression or unacceptable toxicity. Receives: Biological: rituximab; Radiation: yttrium Y 90 ibritumomab tiuxetan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic Response Assessed by MRI or FDG-PET/MRI
Number of patients with at least a 50% reduction in tumor size on a MRI scan with stable or decreasing dose of corticosteroids
Measured: Up to 2 years
Secondary outcomes (4)
Progression Free Survival
The number of patients without an unequivocal increase in tumor size or the appearance of new lesions by MRI
Measured: Up to 2 years
Overall Survival
The number of patients alive up to two years after treatment
Measured: Up to 2 years
Establish the Toxicity Profile of Ibritumomab Tiuxetan in This Patient Population.
Number of patients with toxicities related to the study drug
Measured: Up to 30 days following the last dose of study treatment
Dosimetry Calculations of Yttrium Y 90 Ibritumomab Tiuxetan Assessed by PET/MRI
Number of Gy delivered to each tumor as calculated using the MIRD dosimetry formula on PET data
Measured: At day 11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2013 (estimated)
- Study startMar 2014
- Primary completionJun 2015
- Study completionJun 2015
Why it stopped: Funding Unavailable
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 Primary Central Nervous System Non-Hodgkin LymphomaStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer 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
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Manmeet Ahluwalia, MD, Principal investigator, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01973062
- Sponsor's protocol ID
- CASE4413
- Other IDs
- NCI-2013-01993
- Status last verified
- Jul 2020
- First submitted
- 25 Oct 2013
- Last updated
- 24 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Radioimmunotherapy With Zevalin (Ibritumomab Tiuxetan) Therapy for Patients With Refractory or Relapsed Primary Central Nervous System Lymphoma (PCNSL)
- ClinicalTrials.gov ID
- NCT01973062
- Acronym / sponsor ID
- CASE4413
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding Unavailable
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 31 Oct 2013 (estimated)
- Results
- Posted 20 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II trial studies how well yttrium Y 90 ibritumomab tiuxetan and rituximab work in treating patients with recurrent or refractory primary central nervous system non-Hodgkin lymphoma. Radiolabeled monoclonal antibodies, such as yttrium 90 ibritumomab tiuxetan, can find cancer cells and carry cancer-killing substances to them without harming normal cells. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving yttrium Y 90 ibritumomab tiuxetan with rituximab may kill more cancer cells.
Detailed description
PRIMARY OBJECTIVES:
- Determine the radiographic response proportion in patients with refractory or recurrent primary central nervous system lymphoma (PCNSL) to ibritumomab tiuxetan (yttrium Y 90 ibritumomab tiuxetan) when given as an intravenous infusion.
SECONDARY OBJECTIVES:
- Determine the progression free survival of patients treated with ibritumomab tiuxetan when given as an intravenous infusion.
II. Determine the overall survival of patients treated with ibritumomab tiuxetan when given as an intravenous infusion.
III. Establish the toxicity profile of ibritumomab tiuxetan in this patient population.
IV. Use positron emission tomography (PET)/magnetic resonance imaging (MRI) to map the distribution of Y-90 ibritumomab tiuxetan, and calculate the Gy delivered based on the activity found within tumor.
OUTLINE:
Patients receive rituximab intravenously (IV) on day 1. Within 7 to 9 days, patients receive rituximab IV and yttrium Y 90 ibritumomab tiuxetan IV in the absence of disease progression or unacceptable toxicity. Distribution and dose absorbed dose will be assessed on day 11. Quality of life will be assessed at screening, at day 1, 36, 92, and at each follow-up visit.
After completion of study treatment, patients are followed every 3-6 months for 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| rituximab and yttrium Y 90 ibritumomab tiuxetan | Experimental | Biological: rituximab, Radiation: yttrium Y 90 ibritumomab tiuxetanPatients receive rituximab IV on day 1. Within 7 to 9 days, patients receive rituximab IV and yttrium Y 90 ibritumomab tiuxetan IV in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Patients with histological diagnosis of recurrent or refractory primary central nervous system (CNS) lymphoma with at least 1 measurable gadolinium enhancing lesion on brain MRI scans
- Karnofsky performance status (KPS) >= 60
- Patients could not have had more than 3 prior therapy regimens for the treatment of PCNSL
- Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
- Platelets >= 100 x 10^9/L
Key exclusion criteria (5 listed)
- Pregnant or breast-feeding women
- Patients unwilling or unable to comply with the protocol
- Other concurrent severe and/or uncontrolled concomitant medical conditions (e.g. active infection, uncontrolled diabetes, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, or psychiatric illness, etc.) that could cause unacceptable safety risks or compromise compliance with the protocol
- Known diagnosis of human immunodeficiency virus (HIV) infection; prior radioimmunotherapy, prior myeloablative therapy with autologous bone marrow transplantation or peripheral stem cell rescue, and prior external beam radiation therapy to more than 25% of active bone marrow
- Patients who have received filgrastim (G-CSF) or sargramostim (GM-CSF) within 2 weeks before treatment or major surgery within the prior 4 weeks
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: IDEC-C2B8, IDEC-C2B8 monoclonal antibody, Mabthera, MOAB IDEC-C2B8Given IV | Biological | rituximab and yttrium Y 90 ibritumomab tiuxetan |
| yttrium Y 90 ibritumomab tiuxetanAlso: 90Y ibritumomab tiuxetan, IDEC Y2B8, Y90 Zevalin, Y90-labeled ibritumomab tiuxetanGiven IV | Radiation | rituximab and yttrium Y 90 ibritumomab tiuxetan |
Primary outcome
Radiographic Response Assessed by MRI or FDG-PET/MRI
Time frame: Up to 2 years
Number of patients with at least a 50% reduction in tumor size on a MRI scan with stable or decreasing dose of corticosteroids
4 secondary outcomes
Progression Free Survival
Time frame: Up to 2 years
Overall Survival
Time frame: Up to 2 years
Establish the Toxicity Profile of Ibritumomab Tiuxetan in This Patient Population.
Time frame: Up to 30 days following the last dose of study treatment
Dosimetry Calculations of Yttrium Y 90 Ibritumomab Tiuxetan Assessed by PET/MRI
Time frame: At day 11
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2020.
- 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.
Manmeet Ahluwalia, MD principal investigator
Case Comprehensive Cancer Center
1 site 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 and yttrium Y 90 ibritumomab tiuxetan in people with Primary Central Nervous System Non-Hodgkin Lymphoma, run by Case 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?
The sponsor lists 19 inclusion and 5 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: stopped early, as of the sponsor's last update on 24 Jul 2020. 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?
Yes. Results are posted in the registry (first posted 20 Jul 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?
Radiographic Response Assessed by MRI or FDG-PET/MRI (time frame: Up to 2 years). 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 24 Jul 2020.