Non-Hodgkin's LymphomaPhase 2NCT01549886
Phase 2 Study of Zevalin Versus Zevalin and Motexafin Gadolinium in Patients With Rituximab-Refractory Low-grade or Follicular B-cell Non-Hodgkin's Lymphoma
A Phase 2 study testing Y-90-Zevalin, Moxtezafin Gadolinium and Rituximab in people with Non-Hodgkin's Lymphoma, run by Spectrum Pharmaceuticals, Inc at 9 sites in United States.
Trial summary
The objectives of this study are to evaluate the efficacy and safety of the Zevalin regimen compared to Zevalin and motexafin gadolinium in patients with rituximab-refractory, low-grade or follicular Non-Hodgkin's Lymphoma (NHL). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Hodgkin's Lymphoma
- What is being tested?
- Y-90-Zevalin, Moxtezafin Gadolinium and Rituximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 9 sitesUnited States
- Study dates
- Nov 2011to May 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
- Men or women, at least 18 years of age
- Histologically-confirmed follicular or indolent, marginal zone and small lymphocytic B cell non-Hodgkin's lymphoma
- Progressive disease within 6 months of the end of a rituximab-containing regimen; or progressive disease at any time following 2 or more prior rituximab-containing regimens; or progressive disease while on rituximab-containing regimen.
- At least 1 measurable tumor (> 1.5 cm in the long axis and > 1.0 cm in the short axis) that has not been irradiated previously or that has increased in size since previous irradiation
- A life expectancy of at least 3 months
- A World Health Organization/Eastern Cooperative Oncology Group (WHO/ECOG) performance status of 0 or 1
Show all 12Show fewer
- Adequate hematopoietic function: absolute neutrophil count (ANC) ≥ 1,500 cells/μL, absolute lymphocyte count (ALC) ≤ 5,000 cells/μL, platelet count ≥ 100,000 cells/μL,hemoglobin ≥ 9 g/dL (may be transfused to maintain this concentration). Patients who have received pre-phase therapy for purposes of improving performance status prior to initiating Zevalin are eligible.
- Adequate liver function: total bilirubin ≤ 2 × upper limit of normal (ULN), Aspartate aminotransferase (AST) (Serum glutamic oxaloacetic transaminase [SGOT]) and Alanine transaminase (ALT) (Serum glutamic pyruvic transaminase [SGPT]) ≤ 2.5 × upper limits of normal (ULN)
- Creatinine clearance ≥ 60 mL/min/1.73 m^2
- Bone marrow involvement < 25%
- If men or women of reproductive potential, agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for at least 1 year following treatment with Zevalin
- Willing and able to provide written Informed Consent and to comply with the requirements of the study protocol
Who cannot join
- Received antineoplastic, experimental, and/or radiation therapy within the 3 weeks prior to Study Day 1
- Has not recovered to ≤ Grade 1 from all toxicities related to prior treatments
- Prior radioimmunotherapy for NHL
- Autologous stem cell transplant within the 3 months prior to Study Day 1, and/or any history of allogeneic stem cell transplant with continued allogeneic hematopoiesis
- Platelet transfusion within the 7 days prior to Study Day 1
- History of porphyria
Show all 20Show fewer
- Grade 2 or higher peripheral neuropathy within the 14 days prior to Study Day 1
- History of or active central nervous system disease (e.g., primary brain tumor, seizures not controlled with standard medical therapy, brain metastases)
- Ongoing, active infection that requires anti infective therapy
- Clinically significant cardiovascular disease (e.g., unstable angina pectoris, serious cardiac arrhythmia requiring medication, uncontrolled hypertension, myocardial infarction, New York Heart Association [NYHA] Class 2 or higher congestive heart failure, Grade 2 or higher peripheral vascular disease) within the 12 months prior to Study Day 1
- History of another clinically significant medical condition, metabolic dysfunction, physical examination finding, and/or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or that might affect interpretation of the results of the study or place the patient at high risk of treatment complications and/or of noncompliance with the study procedures
- Major surgical procedure and/or significant traumatic injury (that which could interfere with the patient's ability to receive protocol therapy as determined by the principal investigator) within the 28 days prior to Study Day 1, and/or patient is anticipated to require a major surgical procedure during the study period
- Diagnosed with and/or treated for a malignancy other than NHL within the 2 years prior to Study Day 1, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, and/or low-risk prostate cancer after curative therapy from which the patient has been disease-free for at least 1 year
- Evidence of a bleeding diathesis and/or a coagulopathy
- Known HIV infection
- Known hypersensitivity to drugs with porfyrin-like structures, like Visudyne™.
- Positive Hepatitis B or C infection: Patient must be tested for hepatitis B surface antigen.
- Pregnant or lactating woman
- Full dose oral or parenteral anticoagulants within the 10 days prior to Study Day 1, and/or anticipated full dose oral or parenteral anticoagulant therapy during the study period(except as required to maintain patency of pre-existing, permanent, indwelling intravenous catheters) or thrombolytic agents
- Participated in another clinical study within the 4 weeks prior to Study Day 1
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Alta Bates Summit Medical Center-Herrick
Berkeley, California, 94704
Providence Saint Joseph Medical Center
Burbank, California, 91505
Rush University Medical Center
Chicago, Illinois, 60612
Halifax Health- Center for Oncology
Daytona Beach, Florida, 32114
Hackensack Medical Center
Hackensack, New Jersey, 07601
Loyola University Chicago
Maywood, Illinois, 60153
West Virginia University, WVU Healthcare
Morgantown, West Virginia, 26506
Oncology Specialists
Park Ridge, Illinois, 60068
University of Massachusetts - Worcester
Worcester, Massachusetts, 01655
About this study
Official title: A Randomized, Open-Label, Multi-Center, Phase 2 Study of Zevalin ([90Y]- Ibritumomab Tiuxetan) Versus Zevalin and Motexafin Gadolinium in Patients With Rituximab- Refractory Low-grade or Follicular B-cell Non-Hodgkin's Lymphoma
The objectives of this study are to evaluate the efficacy and safety of the Zevalin regimen compared to Zevalin and motexafin gadolinium in patients with rituximab-refractory, low-grade or follicular Non-Hodgkin's Lymphoma (NHL).
Effectiveness of the experimental regimen assessed by complete response rate within 6 months of study entry (primary endpoint), complete response rate within 3 months of study entry, and overall response rate within 6 month of study entry.
Read the detailed description
This multi-center, randomized, open-label study is designed to compare the safety and efficacy of therapy with Zevalin regimen versus Zevalin and motexafin gadolinium in patients with rituximab-refractory, low-grade or follicular NHL. Approximately 100 adult patients enrolled in the study (approximately 50 in each group at 15 clinical sites in North America).
Patients screened for eligibility within the 14 days prior to Day 1 of the study. Once written informed consent has been obtained and patient eligibility has been established, the patient randomized 1:1 to receive either Zevalin or Zevalin and motexafin gadolinium.
Patients assessed for safety at each visit to the study center and for disease response at Months 3, 6 and 12. An end-of-study-visit performed at Month 12.
Disease status assessed using positron emission tomography (PET) or PET/computerized tomography (CT), and/or flow cytometry. Disease response will be evaluated in accordance with the standardized definitions and criteria of the International Working Group Revised Response Criteria for Malignant Lymphoma. The efficacy endpoints that assessed are complete response rate and overall response rate.
Safety was assessed by adverse events, physical examinations, vital signs, and clinical laboratory assessments. Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) was collected for all patients beginning on Day 1 and continuing through the end-of study-visit to be performed at Month 12 or withdrawal from study.
- Conditions
- Non-Hodgkin's Lymphoma
- Being tested
- Y-90-Zevalin, Moxtezafin Gadolinium, Rituximab
- Keywords
- Non-Hodgkin's Lymphoma, Zevalin, Motexafin Gadolinium
- Medical subject headings
- Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Y-90-ZevalinDrug
Also called [90Y]- ibritumomab tiuxetan (Zevalin)
Day 8 - Y-90-Zevalin 0.4 mCi/kg 10-minute intravenous push
Moxtezafin GadoliniumDrug
Also called MGD
Day 1-4 Motexafin gadolinium 5 mg/kg intravenously once daily, followed in one hour (Day 1 only) by Day 1 Rituximab 250 mg/m^2 intravenous infusion.
Day 8-11 Motexafin gadolinium 5 mg/kg intravenously once daily
RituximabDrug
Day 1 and Day 8: Rituximab 250 mg/m^2 intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| MGD + Rituximab + Y-90-Zevalin | Experimental | Moxtezafin Gadolinium: Day 1-4 Motexafin gadolinium 5 mg/kg intravenously once daily, followed in one hour (Day 1 only) by Day 1 Rituximab 250 mg/m^2 intravenous infusion.
Day 8-11 Motexafin gadolinium 5 mg/kg intravenously once daily, followed in one hour (Day 8 only) by Day 8 Rituximab 250 mg/m^2 intravenous infusion, followed 4 hours later by Y-90-Zevalin 0.4 millicurie / kilogram (mCi/kg) 10-minute intravenous push (0.3 mCi/kg in patients with a platelet count in 100,000/μL to 149,000/μL. Receives: Drug: Y-90-Zevalin; Drug: Moxtezafin Gadolinium; Drug: Rituximab |
| Rituximab + Y-90-Zevalin | Active comparator | Day 1 Rituximab 250 mg/m^2 intravenous infusion. Day 8 Rituximab 250 mg/m^2 intravenous infusion, followed 4 hours later by Y-90-Zevalin 0.4 mCi/kg 10-minute intravenous push Receives: Drug: Y-90-Zevalin; Drug: Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Response Rate (CR)
Measured: 6 Months
Secondary outcomes (2)
Overall Response Rate
Complete response rate within 3 months, overall response rate within 6 months and progression-free survival.
Measured: 3 Months and 6 Months
Number of Participants With Serious Adverse Events and Non-Serious Adverse Events
An Adverse Events (AE) was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly. Non-SAEs was an AE events that are not Serious Adverse Events.
Measured: From time of dosing until 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2012 (estimated)
- Study startNov 2011
- Primary completionJun 2014
- Study completionMay 2015
Why it stopped: Due to business reasons.
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.
- 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
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spectrum Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrew M Evens, DO, MSc, Principal investigator, University of Massachusetts, Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01549886
- Sponsor's protocol ID
- SPI-MGD-11-201
- Status last verified
- Sep 2021
- First submitted
- 6 Mar 2012
- Last updated
- 4 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Multi-Center, Phase 2 Study of Zevalin ([90Y]- Ibritumomab Tiuxetan) Versus Zevalin and Motexafin Gadolinium in Patients With Rituximab- Refractory Low-grade or Follicular B-cell Non-Hodgkin's Lymphoma
- ClinicalTrials.gov ID
- NCT01549886
- Acronym / sponsor ID
- SPI-MGD-11-201
- Conditions
- Non-Hodgkin's Lymphoma
- Keywords
- Non-Hodgkin's Lymphoma, Zevalin, Motexafin Gadolinium
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to business reasons.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Spectrum Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Jun 2014 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 9 Mar 2012 (estimated)
- Results
- Posted 4 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objectives of this study are to evaluate the efficacy and safety of the Zevalin regimen compared to Zevalin and motexafin gadolinium in patients with rituximab-refractory, low-grade or follicular Non-Hodgkin's Lymphoma (NHL).
Effectiveness of the experimental regimen assessed by complete response rate within 6 months of study entry (primary endpoint), complete response rate within 3 months of study entry, and overall response rate within 6 month of study entry.
Detailed description
This multi-center, randomized, open-label study is designed to compare the safety and efficacy of therapy with Zevalin regimen versus Zevalin and motexafin gadolinium in patients with rituximab-refractory, low-grade or follicular NHL. Approximately 100 adult patients enrolled in the study (approximately 50 in each group at 15 clinical sites in North America).
Patients screened for eligibility within the 14 days prior to Day 1 of the study. Once written informed consent has been obtained and patient eligibility has been established, the patient randomized 1:1 to receive either Zevalin or Zevalin and motexafin gadolinium.
Patients assessed for safety at each visit to the study center and for disease response at Months 3, 6 and 12. An end-of-study-visit performed at Month 12.
Disease status assessed using positron emission tomography (PET) or PET/computerized tomography (CT), and/or flow cytometry. Disease response will be evaluated in accordance with the standardized definitions and criteria of the International Working Group Revised Response Criteria for Malignant Lymphoma. The efficacy endpoints that assessed are complete response rate and overall response rate.
Safety was assessed by adverse events, physical examinations, vital signs, and clinical laboratory assessments. Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) was collected for all patients beginning on Day 1 and continuing through the end-of study-visit to be performed at Month 12 or withdrawal from study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MGD + Rituximab + Y-90-Zevalin | Experimental | Drug: Y-90-Zevalin, Drug: Moxtezafin Gadolinium, Drug: RituximabMoxtezafin Gadolinium: Day 1-4 Motexafin gadolinium 5 mg/kg intravenously once daily, followed in one hour (Day 1 only) by Day 1 Rituximab 250 mg/m^2 intravenous infusion. Day 8-11 Motexafin gadolinium 5 mg/kg intravenously once daily, followed in one hour (Day 8 only) by Day 8 Rituximab 250 mg/m^2 intravenous infusion, followed 4 hours later by Y-90-Zevalin 0.4 millicurie / kilogram (mCi/kg) 10-minute intravenous push (0.3 mCi/kg in patients with a platelet count in 100,000/μL to 149,000/μL. |
| Rituximab + Y-90-Zevalin | Active comparator | Drug: Y-90-Zevalin, Drug: RituximabDay 1 Rituximab 250 mg/m^2 intravenous infusion. Day 8 Rituximab 250 mg/m^2 intravenous infusion, followed 4 hours later by Y-90-Zevalin 0.4 mCi/kg 10-minute intravenous push |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Men or women, at least 18 years of age
- Histologically-confirmed follicular or indolent, marginal zone and small lymphocytic B cell non-Hodgkin's lymphoma
- Progressive disease within 6 months of the end of a rituximab-containing regimen; or progressive disease at any time following 2 or more prior rituximab-containing regimens; or progressive disease while on rituximab-containing regimen.
- At least 1 measurable tumor (> 1.5 cm in the long axis and > 1.0 cm in the short axis) that has not been irradiated previously or that has increased in size since previous irradiation
- A life expectancy of at least 3 months
Key exclusion criteria (20 listed)
- Received antineoplastic, experimental, and/or radiation therapy within the 3 weeks prior to Study Day 1
- Has not recovered to ≤ Grade 1 from all toxicities related to prior treatments
- Prior radioimmunotherapy for NHL
- Autologous stem cell transplant within the 3 months prior to Study Day 1, and/or any history of allogeneic stem cell transplant with continued allogeneic hematopoiesis
- Platelet transfusion within the 7 days prior to Study Day 1
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 |
|---|---|---|
| Y-90-ZevalinAlso: [90Y]- ibritumomab tiuxetan (Zevalin)Day 8 - Y-90-Zevalin 0.4 mCi/kg 10-minute intravenous push | Drug | MGD + Rituximab + Y-90-Zevalin, Rituximab + Y-90-Zevalin |
| Moxtezafin GadoliniumAlso: MGDDay 1-4 Motexafin gadolinium 5 mg/kg intravenously once daily, followed in one hour (Day 1 only) by Day 1 Rituximab 250 mg/m^2 intravenous infusion. Day 8-11 Motexafin gadolinium 5 mg/kg intravenously once daily | Drug | MGD + Rituximab + Y-90-Zevalin |
| RituximabDay 1 and Day 8: Rituximab 250 mg/m^2 intravenous infusion | Drug | MGD + Rituximab + Y-90-Zevalin, Rituximab + Y-90-Zevalin |
Primary outcome
Complete Response Rate (CR)
Time frame: 6 Months
2 secondary outcomes
Overall Response Rate
Time frame: 3 Months and 6 Months
Number of Participants With Serious Adverse Events and Non-Serious Adverse Events
Time frame: From time of dosing until 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Non-Hodgkin's Lymphoma
RecruitingPhase 2
Ibrutinib Combination Therapy in Transplant Ineligible Individuals With Newly Diagnosed Primary CNS Lymphoma
Non-hodgkin Lymphoma
Active, not recruitingPhase 2
Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With CD30-Positive Peripheral T-cell Lymphoma
Adult T-Cell Leukemia/Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative
Not yet recruitingPhase 2
Obesity Treatment With Phentermine-Topiramate ER in AYA Surviving Leukemia and Lymphoma
Acute Lymphoblastic Leukemia in Remission, Hodgkin Lymphoma in Remission
Active, not recruitingPhase 2
A Study of Anakinra to Prevent or Treat Severe Side Effects for Patients Receiving CAR-T Cell Therapy
B Cell ALL, B-Cell Lymphoma
Active, not recruitingPhase 1
A Rollover Study of CC-122
Non-Hodgkin Lymphoma
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.
Andrew M Evens, DO, MSc principal investigator
University of Massachusetts, Worcester
9 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 Y-90-Zevalin, Moxtezafin Gadolinium and Rituximab in people with Non-Hodgkin's Lymphoma, run by Spectrum Pharmaceuticals, Inc at 9 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 12 inclusion and 20 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 4 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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 4 Oct 2021). 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?
Complete Response Rate (CR) (time frame: 6 Months). 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 4 Oct 2021.