Post-transplant Lymphoproliferative DisorderPhase 1/2NCT00064246
Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab in Treating Patients With Post-Transplant Lymphoproliferative Disorder
A Phase 1/2 study testing rituximab, indium In 111 ibritumomab tiuxetan and yttrium Y 90 ibritumomab tiuxetan in people with Post-transplant Lymphoproliferative Disorder and Recurrent Adult Burkitt Lymphoma, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Phase I/II trial to study the effectiveness of combining yttrium Y 90 ibritumomab tiuxetan with rituximab in treating patients who have localized or recurrent lymphoproliferative disorder after an organ transplant. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-transplant Lymphoproliferative Disorder, Recurrent Adult Burkitt Lymphoma, Recurrent Adult Diffuse Large Cell Lymphoma
- What is being tested?
- rituximab, indium In 111 ibritumomab tiuxetan 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
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2003to Sep 2004
- Phase
- Phase 1/2
- 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
- Histologically confirmed post-transplant lymphoproliferative disorder (PTLD) of 1 of the following stages:
- Stage III or IV
- Localized (not amenable to localized radiotherapy or excision)
- Recurrent
- The following histologies* are eligible:
- Polyclonal PTLD
Show all 45Show fewer
- Monoclonal PTLD
- Diffuse large B-cell non-Hodgkin's lymphoma (NHL)
- Lymphoplasmacytic NHL
- Burkitt/Burkitt-like NHL
- Must not have completely responded during OR progressed after prior rituximab with or without chemotherapy
- No history of rapid disease progression while receiving prior chemotherapy
- Measurable disease
- Must have less than 25% bone marrow involvement with lymphoma
- Prior solid organ transplantation required
- Evaluation of malignant cells for Epstein-Barr virus (EBV) required
- EBV positive or negative allowed
- No pleural effusion
- No CNS lymphoma, including leptomeningeal disease
- No pulmonary involvement by NHL in patients with prior lung transplantation
- No HIV or AIDS-related lymphoma
- No hypocellular bone marrow (i.e., less than 15% cellularity)
- No marked reduction in bone marrow precursors of one or more cell lines (i.e., granulocytic, megakaryocytic, or erythroid)
- Performance status - Karnofsky 50-100%
- At least 3 months
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 150,000/mm^3
- Bilirubin no greater than 2.5 mg/dL
- Creatinine no greater than 2.5 mg/dL
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 6 months after study participation
- HIV negative
- No serious nonmalignant disease or infection that would compromise study objectives
- No presence of antimurine antibody reactivity
- No other concurrent active malignancy requiring therapy
- More than 2 weeks since prior filgrastim (G-CSF) or sargramostim (GM-CSF)
- More than 6 weeks since prior rituximab
- No prior allogeneic bone marrow or hematopoietic stem cell transplantation
- No prior radioimmunotherapy for NHL
- More than 4 weeks since prior chemotherapy
- See Biologic therapy
- No prior radiotherapy to more than 25% of active bone marrow (involved field or regional)
- More than 4 weeks since prior major surgery except diagnostic surgery
- No other concurrent anticancer therapy
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
AIDS - Associated Malignancies Clinical Trials Consortium
Rockville, Maryland, 20850
About this study
Official title: A Phase I/II Study: Zevalin Radioimmunotherapy for Patients With Post Transplant Lymphoproliferative Disease Following Solid Organ Transplantation
Phase I/II trial to study the effectiveness of combining yttrium Y 90 ibritumomab tiuxetan with rituximab in treating patients who have localized or recurrent lymphoproliferative disorder after an organ transplant. 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
Read the detailed description
OBJECTIVES:
- Determine the safety and tolerability of yttrium Y 90 ibritumomab tiuxetan (IDEC-Y2B8) in patients with post-transplant lymphoproliferative disorder.
II. Determine the safety and toxicity profile of IDEC-Y2B8 and rituximab in these patients.
III. Correlate the Epstein-Barr virus viral load with response and relapse in patients treated with this regimen.
OUTLINE: This is a multicenter, dose-escalation study of yttrium Y 90 ibritumomab tiuxetan (IDEC-Y2B8).
Phase I: Patients receive rituximab IV and indium In 111 ibritumomab tiuxetan IV over 10 minutes on day 1. Patients undergo 2 (or 3 if needed) imaging scans between days 1-6. In the absence of altered biodistribution, patients receive rituximab IV followed within 4 hours by IDEC-Y2B8 IV over 10 minutes on day 8.Cohorts of 6 patients receive escalating doses of IDEC-Y2B8 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 1 of 6 patients experience dose-limiting toxicity.
Phase II: Patients receive treatment as in phase I at the MTD of IDEC-Y2B8. Patients are followed monthly for 3 months, every 3 months for 2 years, and then every 6 months for 2 years.
- Conditions
- Post-transplant Lymphoproliferative Disorder, Recurrent Adult Burkitt Lymphoma, Recurrent Adult Diffuse Large Cell Lymphoma, Stage III Adult Burkitt Lymphoma, Stage III Adult Diffuse Large Cell Lymphoma, Stage IV Adult Burkitt Lymphoma
- Being tested
- rituximab, indium In 111 ibritumomab tiuxetan, yttrium Y 90 ibritumomab tiuxetan
- Medical subject headings
- Burkitt Lymphoma, Lymphoma, Large B-Cell, Diffuse, Waldenstrom Macroglobulinemia
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
indium In 111 ibritumomab tiuxetanRadiation
Also called IDEC-In2B8
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 |
|---|---|---|
| Treatment (rituximab, yttrium Y 90 ibritumomab tiuxetan) | Experimental | Phase I: Patients receive rituximab IV and indium In 111 ibritumomab tiuxetan IV over 10 minutes on day 1. Patients undergo 2 (or 3 if needed) imaging scans between days 1-6. In the absence of altered biodistribution, patients receive rituximab IV followed within 4 hours by IDEC-Y2B8 IV over 10 minutes on day 8.
Phase II: Patients receive treatment as in phase I at the MTD of IDEC-Y2B8. Patients are followed monthly for 3 months, every 3 months for 2 years, and then every 6 months for 2 years. Receives: Biological: rituximab; Radiation: indium In 111 ibritumomab tiuxetan; 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
Estimated using binomial proportions and their 95% confidence intervals.
Measured: Up to 4 years
Secondary outcomes (3)
Time to response
Analyzed by the Kaplan-Meier non-parametric methods.
Measured: Up to 4 years
Time to progression
Analyzed by the Kaplan-Meier non-parametric methods.
Measured: From the date of first study treatment to the first date when progressive disease is documented, assessed up to 4 years
Incidence of toxicity related dose reductions graded according to the NCI CTCAE version 3.0
Presented by severity for each dose group.
Measured: Up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2003 (estimated)
- Study startJul 2003
- Primary completionSep 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-transplant Lymphoproliferative DisorderStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- David Scadden, Principal investigator, AIDS Associated Malignancies Clinical Trials Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00064246
- Sponsor's protocol ID
- NCI-2012-02721
- Other IDs
- AMC-037, U01CA070019, CDR0000310158
- Status last verified
- Jan 2013
- First submitted
- 8 Jul 2003
- Last updated
- 25 Jan 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study: Zevalin Radioimmunotherapy for Patients With Post Transplant Lymphoproliferative Disease Following Solid Organ Transplantation
- ClinicalTrials.gov ID
- NCT00064246
- Acronym / sponsor ID
- NCI-2012-02721
- Conditions
- Post-transplant Lymphoproliferative Disorder, Recurrent Adult Burkitt Lymphoma, Recurrent Adult Diffuse Large Cell Lymphoma, Stage III Adult Burkitt Lymphoma, Stage III Adult Diffuse Large Cell Lymphoma, Stage IV Adult Burkitt Lymphoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Jul 2003
- Primary completion
- Sep 2004 (actual)
- First posted
- 9 Jul 2003 (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.
Phase I/II trial to study the effectiveness of combining yttrium Y 90 ibritumomab tiuxetan with rituximab in treating patients who have localized or recurrent lymphoproliferative disorder after an organ transplant. 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
Detailed description
OBJECTIVES:
- Determine the safety and tolerability of yttrium Y 90 ibritumomab tiuxetan (IDEC-Y2B8) in patients with post-transplant lymphoproliferative disorder.
II. Determine the safety and toxicity profile of IDEC-Y2B8 and rituximab in these patients.
III. Correlate the Epstein-Barr virus viral load with response and relapse in patients treated with this regimen.
OUTLINE: This is a multicenter, dose-escalation study of yttrium Y 90 ibritumomab tiuxetan (IDEC-Y2B8).
Phase I: Patients receive rituximab IV and indium In 111 ibritumomab tiuxetan IV over 10 minutes on day 1. Patients undergo 2 (or 3 if needed) imaging scans between days 1-6. In the absence of altered biodistribution, patients receive rituximab IV followed within 4 hours by IDEC-Y2B8 IV over 10 minutes on day 8.Cohorts of 6 patients receive escalating doses of IDEC-Y2B8 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 1 of 6 patients experience dose-limiting toxicity.
Phase II: Patients receive treatment as in phase I at the MTD of IDEC-Y2B8. Patients are followed monthly for 3 months, every 3 months for 2 years, and then every 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 |
|---|---|---|
| Treatment (rituximab, yttrium Y 90 ibritumomab tiuxetan) | Experimental | Biological: rituximab, Radiation: indium In 111 ibritumomab tiuxetan, Radiation: yttrium Y 90 ibritumomab tiuxetanPhase I: Patients receive rituximab IV and indium In 111 ibritumomab tiuxetan IV over 10 minutes on day 1. Patients undergo 2 (or 3 if needed) imaging scans between days 1-6. In the absence of altered biodistribution, patients receive rituximab IV followed within 4 hours by IDEC-Y2B8 IV over 10 minutes on day 8. Phase II: Patients receive treatment as in phase I at the MTD of IDEC-Y2B8. Patients are followed monthly for 3 months, every 3 months for 2 years, and then every 6 months for 2 years. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (45 listed)
- Histologically confirmed post-transplant lymphoproliferative disorder (PTLD) of 1 of the following stages:
- The following histologies* are eligible:
- Must not have completely responded during OR progressed after prior rituximab with or without chemotherapy
- Measurable disease
- Must have less than 25% bone marrow involvement with lymphoma
Key exclusion criteria (0 listed)
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 | Treatment (rituximab, yttrium Y 90 ibritumomab tiuxetan) |
| indium In 111 ibritumomab tiuxetanAlso: IDEC-In2B8Given IV | Radiation | Treatment (rituximab, yttrium Y 90 ibritumomab tiuxetan) |
| yttrium Y 90 ibritumomab tiuxetanAlso: 90Y ibritumomab tiuxetan, IDEC Y2B8, Y90 Zevalin, Y90-labeled ibritumomab tiuxetanGiven IV | Radiation | Treatment (rituximab, yttrium Y 90 ibritumomab tiuxetan) |
Primary outcome
Response rate
Time frame: Up to 4 years
Estimated using binomial proportions and their 95% confidence intervals.
3 secondary outcomes
Time to response
Time frame: Up to 4 years
Time to progression
Time frame: From the date of first study treatment to the first date when progressive disease is documented, assessed up to 4 years
Incidence of toxicity related dose reductions graded according to the NCI CTCAE version 3.0
Time frame: Up to 4 years
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 25 Jan 2013.
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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.
David Scadden principal investigator
AIDS Associated Malignancies Clinical Trials Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing rituximab, indium In 111 ibritumomab tiuxetan and yttrium Y 90 ibritumomab tiuxetan in people with Post-transplant Lymphoproliferative Disorder and Recurrent Adult Burkitt Lymphoma, run by National Cancer Institute (NCI) 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 45 inclusion and 0 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 25 Jan 2013. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Response rate (time frame: Up to 4 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 25 Jan 2013.