LymphomaPhase 2NCT00493467
Zevalin (Ibritumomab Tiuxetan) for Early Stage Indolent Lymphomas
A Phase 2 study testing Ibritumomab Tiuxetan (Zevalin) and Rituximab in people with Lymphoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to find out if giving (Rituxan) rituximab with 90Y (ibritumomab tiuxetan) (90 Y Zevalin®) may be effective in treating low-grade lymphoma. The safety of this combination treatment will also be studied. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma
- What is being tested?
- Ibritumomab Tiuxetan (Zevalin) and Rituximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to 11 Aug 2022
- 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
- New diagnosis of low-grade indolent lymphomas Stage I-II. Patients with multiple skin lesions will be eligible provided that the skin is the only site of involvement.
- Histology includes Indolent cluster of differentiation antigen 20 (CD20)+ lymphomas including: Follicular lymphoma, Extranodal marginal lymphoma of MALT type, Nodal Marginal zone B-cell lymphoma (+/- monocytoid cells), and Splenic marginal B-cell lymphoma (+/- villous lymphocytes).
- Signed Informed Consent.
- Age >/= 18 years.
- Pre-study Zubrod performance status of 0, 1, or 2.
- Acceptable hematologic status within two weeks prior to patient registration, including: absolute neutrophil count ([segmented neutrophils + bands] x total WBC) >/= 1, 500/mm^3, total lymphocyte count </= 5,000/mm^3 and platelet counts >/= 100,000/mm^3.
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- Female patients who are not pregnant or lactating.
- Men and women of reproductive potential who are following accepted birth control methods (as determined by the treating physician, however abstinence is not an acceptable method).
- Patients determined to have < 25% bone marrow involvement with lymphoma within six weeks of registration (define measurement of a bone marrow aspirate or biopsy).
- Patient should have at least one lesion measuring >/= 1.5 cm in a single dimension. Measurable cutaneous lesions are allowed.
Who cannot join
- Presence of central nervous system (CNS) lymphoma.
- Patients with HIV or AIDS-related lymphoma.
- Patients with pleural effusion.
- Patients with abnormal liver function: total bilirubin > 2.0 mg/dL.
- Patients with abnormal renal function: serum creatinine > 2.0 mg/dL.
- Patients who have received prior external beam radiation therapy to > 25% of active bone marrow (involved field or regional).
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- Impaired bone marrow reserve as indicated by < 15% bone marrow cellularity
- Serious nonmalignant disease or infection which, in the opinion of the investigator and/or the sponsor, would compromise other protocol objectives.
- Major surgery, other than diagnostic surgery, within four weeks.
- Evidence of transformation in the latest biopsy.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Phase II Study of Zevalin for the Treatment of Early-Stage Indolent Lymphomas
The goal of this clinical research study is to find out if giving (Rituxan) rituximab with 90Y (ibritumomab tiuxetan) (90 Y Zevalin®) may be effective in treating low-grade lymphoma. The safety of this combination treatment will also be studied.
Read the detailed description
90 Y Zevalin and rituximab are both designed to attach to lymphoma cells, causing them to die.
Before you can start treatment on this study, you will have "screening tests." These tests will help the doctor decide if you are eligible to take part in this study. You will have a physical exam. Blood (about 2 to 3 teaspoons) and urine will be collected for routine tests. You will have a chest x-ray and computerized tomography (CT) scans of the neck, chest, abdomen (stomach area), and pelvis.
A PET scan is also recommended. A PET (Positron Emission Tomography) scan is a medical technique that monitors the activity in the brain and other organs by tracking the movement of a special radioactive solution through the body. The radioactive solution is either inhaled as a mist or injected into a vein. The radioactive solution is usually made from simple sugar that has radioactive particles attached to it. After the solution is injected into a vein or inhaled, the PET scanner takes pictures of the radioactive solution as it moves through the body and collects in various organs. By watching how the solution travels through the body and studying where the solution collects, researchers can learn the extent of disease in certain organs in the body.
You will have an electrocardiogram (ECG -- a test that measures the electrical activity of the heart). You will have a bone marrow aspirate and biopsy performed. To collect a bone marrow aspirate and biopsy, an area of the hip or chest bone is numbed with anesthetic, and a small amount of bone marrow and bone is withdrawn through a large needle. Women who are able to have children must have a negative blood or urine pregnancy test.
If you are found to be eligible to take part in this study, you will be given diphenhydramine (Benadryl) by vein and you will take acetaminophen (Tylenol) by mouth before each dose of rituximab. This is done to help decrease the risk of developing side effects of rituximab. You will then receive 1 dose of rituximab by vein over about 4-6 hours on Day 1 of treatment. After treatment with rituximab, you will then be given 111 In Zevalin (this is a radioactive agent that binds to rituximab to help with imaging exams), by vein over about 10 minutes. This is so researchers can use a special camera to see where the drug is in your body.
You will have imaging performed (on a camera, like an x-ray) on either Day 2 or 3. On Day 8 (7 days after the first dose of rituximab) you will receive a second dose of rituximab. You will also be given Benadryl, Tylenol, and 90Y Zevalin in the same manner as on Day 1.
If you experience intolerable side effects while on this study, you may be removed from this study. Your treatment on the study will end on Day 8.
You will return for follow-up tests for 4 years. Blood (about 2 tablespoons) will be drawn weekly for the first 3 months. Blood (about 2 tablespoons each time) will also be drawn at month 6 and 9 of the first year, and every 6 months in the second, third, and fourth years. You may also have CT scans, PET scans (which are recommended), x-rays, and bone marrow biopsies and aspirates performed, if your doctor thinks they are necessary.
Your participation on this study will end in about 4 years.
This is an investigational study. 90 Y Zevalin and rituximab are FDA approved and commercially available. Their use in this study is investigational. Up to 36 patients will take part in this multicenter study. Up to 36 patients will be enrolled at M. D. Anderson.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ibritumomab Tiuxetan (Zevalin)Drug
Also called Ibritumomab, Zevalin, IDEC-Y2B8
111In Zevalin (5 mCi of ^111In, 1.6 mg of Ibritumomab Tiuxetan) Intravenously Over 10 minutes on Day 1.
90Y Zevalin 0.3 or 0.4 mCi/kg Intravenously Over 10 minutes on Day 8.
RituximabDrug
Also called Rituxan
250 mg/m^2 Intravenously Over 4-6 Hours On Days 1 and 8.
| Study group | Role | What they receive |
|---|---|---|
| Zevalin | Experimental | Ibritumomab Tiuxetan (Zevalin) + Rituximab Receives: Drug: Ibritumomab Tiuxetan (Zevalin); Drug: Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (ORR)
ORR defined as the percentage of number of complete response (CR), complete response unconfirmed (CRu) or partial response (PR) in patients treated using International Working Group (IWG) revised response criteria for Malignant Lymphoma. ORR to therapy is evaluated after three months using radiographic and clinical parameters to assess response. CR: Complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms. CRu: A residual lymph node mass greater than 1.5 cm in greatest transverse diameter that has regressed by more than 75% in the sum of the products of the greatest diameters (SPD). Individual nodes that were previously confluent must have regressed by more than 75% in their SPD compared to the original mass and indeterminate bone marrow. PR: ≥ 50% decrease in SPD of the six largest dominant nodes or nodal masses. No increase in the size of other nodes, liver or spleen and no new sites of disease.
Measured: Up to 5 years; Evaluation at 3-month intervals during Year 1, then every 6 months to Year 4. The median follow-up was 56 months for censored observations.
Secondary outcomes (1)
Progression Free Survival (PFS) Rate at 3 Years
PFS measured, in a responder, from the date when a CR, CRu or PR is first noted to the first date at which progressive disease is observed or death. An ongoing PFS interval occurs when there is a responder for whom progressive disease has not been noted. Progression of disease defined as enlargement of liver/spleen, new sites observed, new or increased lymph nodes or lymph node masses, or reappearance of bone marrow.
Measured: Evaluation at 3-month intervals during the first year and then every 6 months until year 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2007 (estimated)
- Study startJun 2006
- Primary completionApr 2015
- Study completion11 Aug 2022
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 M.D. Anderson 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
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Biogen, CTI BioPharma
- Responsible party
- Sponsor
- Investigators
- Felipe Samaniego, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00493467
- Sponsor's protocol ID
- 2005-0512
- Other IDs
- NCI-2012-01569
- Status last verified
- Aug 2022
- First submitted
- 27 Jun 2007
- Last updated
- 15 Sep 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Zevalin for the Treatment of Early-Stage Indolent Lymphomas
- ClinicalTrials.gov ID
- NCT00493467
- Acronym / sponsor ID
- 2005-0512
- Conditions
- Lymphoma
- Keywords
- Non-Hodgkin's Lymphoma, Lymphoma, Indolent Lymphomas, Ibritumomab Tiuxetan, Zevalin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Biogen, CTI BioPharma
- Study start
- Jun 2006
- Primary completion
- Apr 2015 (actual)
- Study completion
- 11 Aug 2022 (actual)
- First posted
- 28 Jun 2007 (estimated)
- Results
- Posted 1 Sep 2020
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 giving (Rituxan) rituximab with 90Y (ibritumomab tiuxetan) (90 Y Zevalin®) may be effective in treating low-grade lymphoma. The safety of this combination treatment will also be studied.
Detailed description
90 Y Zevalin and rituximab are both designed to attach to lymphoma cells, causing them to die.
Before you can start treatment on this study, you will have "screening tests." These tests will help the doctor decide if you are eligible to take part in this study. You will have a physical exam. Blood (about 2 to 3 teaspoons) and urine will be collected for routine tests. You will have a chest x-ray and computerized tomography (CT) scans of the neck, chest, abdomen (stomach area), and pelvis.
A PET scan is also recommended. A PET (Positron Emission Tomography) scan is a medical technique that monitors the activity in the brain and other organs by tracking the movement of a special radioactive solution through the body. The radioactive solution is either inhaled as a mist or injected into a vein. The radioactive solution is usually made from simple sugar that has radioactive particles attached to it. After the solution is injected into a vein or inhaled, the PET scanner takes pictures of the radioactive solution as it moves through the body and collects in various organs. By watching how the solution travels through the body and studying where the solution collects, researchers can learn the extent of disease in certain organs in the body.
You will have an electrocardiogram (ECG -- a test that measures the electrical activity of the heart). You will have a bone marrow aspirate and biopsy performed. To collect a bone marrow aspirate and biopsy, an area of the hip or chest bone is numbed with anesthetic, and a small amount of bone marrow and bone is withdrawn through a large needle. Women who are able to have children must have a negative blood or urine pregnancy test.
If you are found to be eligible to take part in this study, you will be given diphenhydramine (Benadryl) by vein and you will take acetaminophen (Tylenol) by mouth before each dose of rituximab. This is done to help decrease the risk of developing side effects of rituximab. You will then receive 1 dose of rituximab by vein over about 4-6 hours on Day 1 of treatment. After treatment with rituximab, you will then be given 111 In Zevalin (this is a radioactive agent that binds to rituximab to help with imaging exams), by vein over about 10 minutes. This is so researchers can use a special camera to see where the drug is in your body.
You will have imaging performed (on a camera, like an x-ray) on either Day 2 or 3. On Day 8 (7 days after the first dose of rituximab) you will receive a second dose of rituximab. You will also be given Benadryl, Tylenol, and 90Y Zevalin in the same manner as on Day 1.
If you experience intolerable side effects while on this study, you may be removed from this study. Your treatment on the study will end on Day 8.
You will return for follow-up tests for 4 years. Blood (about 2 tablespoons) will be drawn weekly for the first 3 months. Blood (about 2 tablespoons each time) will also be drawn at month 6 and 9 of the first year, and every 6 months in the second, third, and fourth years. You may also have CT scans, PET scans (which are recommended), x-rays, and bone marrow biopsies and aspirates performed, if your doctor thinks they are necessary.
Your participation on this study will end in about 4 years.
This is an investigational study. 90 Y Zevalin and rituximab are FDA approved and commercially available. Their use in this study is investigational. Up to 36 patients will take part in this multicenter study. Up to 36 patients will be enrolled at M. D. Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Zevalin | Experimental | Drug: Ibritumomab Tiuxetan (Zevalin), Drug: RituximabIbritumomab Tiuxetan (Zevalin) + Rituximab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- New diagnosis of low-grade indolent lymphomas Stage I-II. Patients with multiple skin lesions will be eligible provided that the skin is the only site of involvement.
- Histology includes Indolent cluster of differentiation antigen 20 (CD20)+ lymphomas including: Follicular lymphoma, Extranodal marginal lymphoma of MALT type, Nodal Marginal zone B-cell lymphoma (+/- monocytoid cells), and Splenic marginal B-cell lymphoma (+/- villous lymphocytes).
- Signed Informed Consent.
- Age >/= 18 years.
- Pre-study Zubrod performance status of 0, 1, or 2.
Key exclusion criteria (10 listed)
- Presence of central nervous system (CNS) lymphoma.
- Patients with HIV or AIDS-related lymphoma.
- Patients with pleural effusion.
- Patients with abnormal liver function: total bilirubin > 2.0 mg/dL.
- Patients with abnormal renal function: serum creatinine > 2.0 mg/dL.
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 |
|---|---|---|
| Ibritumomab Tiuxetan (Zevalin)Also: Ibritumomab, Zevalin, IDEC-Y2B8111In Zevalin (5 mCi of ^111In, 1.6 mg of Ibritumomab Tiuxetan) Intravenously Over 10 minutes on Day 1. 90Y Zevalin 0.3 or 0.4 mCi/kg Intravenously Over 10 minutes on Day 8. | Drug | Zevalin |
| RituximabAlso: Rituxan250 mg/m^2 Intravenously Over 4-6 Hours On Days 1 and 8. | Drug | Zevalin |
Primary outcome
Overall Response Rate (ORR)
Time frame: Up to 5 years; Evaluation at 3-month intervals during Year 1, then every 6 months to Year 4. The median follow-up was 56 months for censored observations.
ORR defined as the percentage of number of complete response (CR), complete response unconfirmed (CRu) or partial response (PR) in patients treated using International Working Group (IWG) revised response criteria for Malignant Lymphoma. ORR to therapy is evaluated after three months using radiographic and clinical parameters to assess response. CR: Complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms. CRu: A residual lymph node mass greater than 1.5 cm in greatest transverse diameter that has regressed by more than 75% in the sum of the products of the greatest diameters (SPD). Individual nodes that were previously confluent must have regressed by more than 75% in their SPD compared to the original mass and indeterminate bone marrow. PR: ≥ 50% decrease in SPD of the six largest dominant nodes or nodal masses. No increase in the size of other nodes, liver or spleen and no new sites of disease.
1 secondary outcome
Progression Free Survival (PFS) Rate at 3 Years
Time frame: Evaluation at 3-month intervals during the first year and then every 6 months until year 3
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
Felipe Samaniego, MD principal investigator
M.D. Anderson 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 Ibritumomab Tiuxetan (Zevalin) and Rituximab in people with Lymphoma, run by M.D. Anderson 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 10 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 15 Sep 2022. 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 1 Sep 2020). 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?
Overall Response Rate (ORR) (time frame: Up to 5 years; Evaluation at 3-month intervals during Year 1, then every 6 months to Year 4. The median follow-up was 56 months for censored observations.). 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 15 Sep 2022.