LymphomaNCT00897923
Imaging of Radiolabeled White Blood Cells in Patients With Non-Hodgkin's Lymphoma
An observational study of Lymphoma and Small Intestine Cancer, run by Mayo Clinic at 2 sites in United States.
Trial summary
RATIONALE: Measuring the number of radiolabeled white blood cells in non-Hodgkin's lymphoma tumors may help doctors predict how well patients will respond to treatment, and may help the study of cancer in the future. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Lymphoma, Small Intestine Cancer
- What is being tested?
- radionuclide imaging, indium In 111-labeled autologous peripheral blood mononuclear cells and indium In 111-labeled autologous polymorphonuclear leukocytes
- Type of treatment
- Surgery or procedure
- How many people
- 17 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2003to 10 Feb 2012
- Phase
- Observational
- 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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: community sample
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed non-Hodgkin's lymphoma
- Indolent or aggressive disease
- Planning to receive a new regimen or starting a regimen of cancer therapy
- At least one tumor lesion measurable in two dimensions as ≥ 1.5 cm by CT scan
PATIENT CHARACTERISTICS:
- ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%
- Life expectancy ≥ 3 months
- No concurrent medical complications that would preclude study compliance
- Not pregnant or nursing
PRIOR CONCURRENT THERAPY:
- At least 3 weeks since prior chemotherapy (except for nonmyelosuppressive treatments)
- At least 3 weeks since prior radiation therapy
- Concurrent rituximab allowed
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, 52242-1002
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
About this study
Official title: In Vivo Imaging of Effector Cells in Anti-Lymphoma Therapy
RATIONALE: Measuring the number of radiolabeled white blood cells in non-Hodgkin's lymphoma tumors may help doctors predict how well patients will respond to treatment, and may help the study of cancer in the future.
PURPOSE: This study is measuring radiolabeled white blood cells in patients with non-Hodgkin's lymphoma.
Read the detailed description
OBJECTIVES:
- Determine the number of indium In 111-labeled peripheral blood mononuclear cells (PBMCs) and indium In 111-labeled polymorphonuclear leukocytes (PMNLs) trafficking into lymphoma tumors prior to therapy in patients with non-Hodgkin's lymphoma.
- Compare the number of PBMC and PMNL trafficking prior to vs after therapy in these patients.
- Compare, preliminarily, the number of in vivo baseline (i.e., pre-therapy) trafficking of PBMCs vs PMNLs in these patients.
- Gather important data regarding the inter- and intra-patient variability of effector cell trafficking into these tumors.
- Assess the relationship between response at 8-12 weeks and the magnitude of baseline effector cell trafficking or the magnitude of post-rituximab effector cell trafficking in these patients.
OUTLINE: This is a multicenter study. Patients are assigned to 1 of 2 groups.
- Group I: Patients receive autologous indium In 111 (^111In)-labeled peripheral blood mononuclear cells on day 0.
- Group II: Patients receive autologous ^111In-labeled polymorphonuclear leukocytes on day 0.
In both groups, patients undergo blood collection on day 0. Patients then undergo full-body single-photon emission-computed tomography (SPECT) scan 4 hours after cell infusion and on day 2. The labeling and imaging process may be repeated after at least 1 course of anticancer treatment.
Cellular uptake is measured by reader/visual interpretation, a semiquantitative grading system, and tumor-to-background uptake ratios.
PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.
- Conditions
- Lymphoma, Small Intestine Cancer
- Being tested
- radionuclide imaging, indium In 111-labeled autologous peripheral blood mononuclear cells, indium In 111-labeled autologous polymorphonuclear leukocytes
- Keywords
- AIDS-related peripheral/systemic lymphoma, AIDS-related primary CNS lymphoma, anaplastic large cell lymphoma, angioimmunoblastic T-cell lymphoma, extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue, intraocular lymphoma, nodal marginal zone B-cell lymphoma, primary central nervous system non-Hodgkin lymphoma, recurrent adult Burkitt lymphoma, recurrent adult diffuse large cell lymphoma, recurrent adult diffuse mixed cell lymphoma, recurrent adult diffuse small cleaved cell lymphoma, recurrent adult immunoblastic large cell lymphoma, recurrent adult lymphoblastic lymphoma, recurrent adult T-cell leukemia/lymphoma, recurrent cutaneous T-cell non-Hodgkin lymphoma, recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma, recurrent mantle cell lymphoma
- Medical subject headings
- Lymphoma, Lymphoma, Large-Cell, Anaplastic, Immunoblastic Lymphadenopathy, Intraocular Lymphoma, Lymphoma, B-Cell, Marginal Zone, Burkitt Lymphoma, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radionuclide imagingProcedure or surgery
indium In 111-labeled autologous peripheral blood mononuclear cellsRadiation
indium In 111-labeled autologous polymorphonuclear leukocytesRadiation
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of baseline indium In 111-labeled peripheral blood mononuclear cells (PBMCs) trafficking into tumors
Number of baseline indium In 111-labeled polymorphonuclear leukocytes (PMNLs) trafficking into tumors
Number of PBMC and PMNL trafficking prior to vs after therapy
Cellular uptake of PBMCs and PMNLs as measured by reader/visual interpretation, semiquantitative grading system, and tumor-to-background uptake ratios
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2009 (estimated)
- Study startSep 2003
- Primary completion10 Feb 2012
- Study completion10 Feb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Gregory Wiseman, MD, Study chair, Mayo ClinicMichael M. Graham, PhD, MD, Principal investigator, Holden Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00897923
- Sponsor's protocol ID
- CDR0000529768
- Other IDs
- UIHC-LS0383, MAYO-IRB-1414-03
- Status last verified
- Apr 2016
- First submitted
- 9 May 2009
- Last updated
- 22 Mar 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vivo Imaging of Effector Cells in Anti-Lymphoma Therapy
- ClinicalTrials.gov ID
- NCT00897923
- Acronym / sponsor ID
- CDR0000529768
- Conditions
- Lymphoma, Small Intestine Cancer
- Keywords
- AIDS-related peripheral/systemic lymphoma, AIDS-related primary CNS lymphoma, anaplastic large cell lymphoma, angioimmunoblastic T-cell lymphoma, extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue, intraocular lymphoma, nodal marginal zone B-cell lymphoma, primary central nervous system non-Hodgkin lymphoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Sep 2003
- Primary completion
- 10 Feb 2012 (actual)
- Study completion
- 10 Feb 2012 (actual)
- First posted
- 12 May 2009 (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.
RATIONALE: Measuring the number of radiolabeled white blood cells in non-Hodgkin's lymphoma tumors may help doctors predict how well patients will respond to treatment, and may help the study of cancer in the future.
PURPOSE: This study is measuring radiolabeled white blood cells in patients with non-Hodgkin's lymphoma.
Detailed description
OBJECTIVES:
- Determine the number of indium In 111-labeled peripheral blood mononuclear cells (PBMCs) and indium In 111-labeled polymorphonuclear leukocytes (PMNLs) trafficking into lymphoma tumors prior to therapy in patients with non-Hodgkin's lymphoma.
- Compare the number of PBMC and PMNL trafficking prior to vs after therapy in these patients.
- Compare, preliminarily, the number of in vivo baseline (i.e., pre-therapy) trafficking of PBMCs vs PMNLs in these patients.
- Gather important data regarding the inter- and intra-patient variability of effector cell trafficking into these tumors.
- Assess the relationship between response at 8-12 weeks and the magnitude of baseline effector cell trafficking or the magnitude of post-rituximab effector cell trafficking in these patients.
OUTLINE: This is a multicenter study. Patients are assigned to 1 of 2 groups.
- Group I: Patients receive autologous indium In 111 (^111In)-labeled peripheral blood mononuclear cells on day 0.
- Group II: Patients receive autologous ^111In-labeled polymorphonuclear leukocytes on day 0.
In both groups, patients undergo blood collection on day 0. Patients then undergo full-body single-photon emission-computed tomography (SPECT) scan 4 hours after cell infusion and on day 2. The labeling and imaging process may be repeated after at least 1 course of anticancer treatment.
Cellular uptake is measured by reader/visual interpretation, a semiquantitative grading system, and tumor-to-background uptake ratios.
PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- community sample
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 |
|---|---|---|
| radionuclide imaging | Procedure or surgery | – |
| indium In 111-labeled autologous peripheral blood mononuclear cells | Radiation | – |
| indium In 111-labeled autologous polymorphonuclear leukocytes | Radiation | – |
Primary outcome
Number of baseline indium In 111-labeled peripheral blood mononuclear cells (PBMCs) trafficking into tumors
Number of baseline indium In 111-labeled polymorphonuclear leukocytes (PMNLs) trafficking into tumors
Number of PBMC and PMNL trafficking prior to vs after therapy
Cellular uptake of PBMCs and PMNLs as measured by reader/visual interpretation, semiquantitative grading system, and tumor-to-background uptake ratios
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 22 Mar 2017.
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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.
Gregory Wiseman, MD study chair
Mayo Clinic
Michael M. Graham, PhD, MD principal investigator
Holden Comprehensive Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphoma and Small Intestine Cancer, run by Mayo Clinic 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 22 Mar 2017. 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.
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?
Number of baseline indium In 111-labeled peripheral blood mononuclear cells (PBMCs) trafficking into tumors. The study lists 4 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 22 Mar 2017.