A Phase 2 interventional study of rituximab and ibritumomab tiuxetan in Refractory Non Hodgkin Lymphoma and Relapsed Non Hodgkin Lymphoma, sponsored by Joseph Tuscano. Status unknown at 1 site in United States. Open to participants aged 19 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-11-30.
Sponsored by Joseph Tuscano · Phase 2, Interventional, and Treatment
This phase II trial studies how well ibritumomab tiuxetan before donor peripheral blood stem cell transplant works in treating patients with relapsed or refractory non-Hodgkin lymphoma. Giving rituximab, antithymocyte globulin, and total-lymphoid irradiation (TLI) before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells and helps stop the patient's immune system from rejecting the donor's stem cells. Also, radiolabeled monoclonal antibodies, such as ibritumomab tiuxetan, can find cancer cells and carry cancer-killing substances to them without harming normal cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving rituximab, antithymocyte globulin, and TLI before the transplant together with cyclosporine and mycophenolate mofetil after the transplant may stop this from happening. Giving a radiolabeled monoclonal antibody before a donor peripheral blood stem cell transplant may be an effective treatment for non-Hodgkin lymphoma.
PRIMARY OBJECTIVES:
I. To measure the response conversion (progressive disease [PD]/stable disease [SD] to partial response [PR] and complete response [CR]).
SECONDARY OBJECTIVES:
I. To assess the time to engraftment/chimerism. II. To assess the rate of acute and chronic graft-versus-host disease (GVHD). III. To assess toxicity. IV. To determine the overall survival. V. To investigate immune functional and phenotypic analysis. VI. To measure two year event free survival (EFS).
OUTLINE:
CONDITIONING REGIMEN: Patients receive rituximab intravenously (IV) on days -21 and 14, ibritumomab tiuxetan IV on day -14, TLI on days -11 to -7 and -4 to -1, and antithymocyte globulin IV over 4-6 hours on days -11 to -7. Patients also undergo TLI on days -11 to -7 and -4 to -1.
TRANSPLANT: Patients undergo allogeneic peripheral blood stem cell transplant (PBSCT) on day 0.
GVHD PROPHYLAXIS: Patients receive cyclosporine orally (PO) twice daily (BID) or IV on days -3 to 56 with taper to 6 months and mycophenolate mofetil PO BID or IV on days 0-28.
After completion of study treatment, patients are followed up periodically.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's planned enrollment of 20 is below the median of 40 across 4,508 interventional studies indexed under Lymphoma.
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Exclusion Criteria:
Patients with any of the following liver function abnormalities will be excluded:
CONDITIONING REGIMEN: Patients receive rituximab IV on days -21 and 14, ibritumomab tiuxetan IV on day -14, TLI on days -11 to -7 and -4 to -1, and antithymocyte globulin IV over 4-6 hours on days -11 to -7. Patients also undergo TLI on days -11 to -7 and -4 to -1. TRANSPLANT: Patients undergo allogeneic PBSCT on day 0. GVHD PROPHYLAXIS: Patients receive cyclosporine PO BID or IV on days -3 to 56 with taper to 6 months and mycophenolate mofetil PO BID or IV on days 0-28.
Biological: rituximab · Biological: ibritumomab tiuxetan · Biological: anti-thymocyte globulin · Radiation: total nodal irradiation · Procedure: peripheral blood stem cell transplantation · Procedure: allogeneic hematopoietic stem cell transplantation · Drug: cyclosporine · Drug: mycophenolate mofetil
Given IV
Also known as: IDEC-C2B8, Mabthera, Rituxan
Given IV
Also known as: Zevalin
Given IV
Also known as: ATG, ATGAM, lymphocyte immune globulin, Thymoglobulin
Undergo TLI
Also known as: TLI, total lymphoid irradiation
Undergo allogeneic peripheral blood stem cell transplant
Also known as: PBPC transplantation, PBSC transplantation, peripheral blood progenitor cell transplantation, transplantation, peripheral blood stem cell
Undergo allogeneic peripheral blood stem cell transplant
Given PO or IV
Also known as: cyclosporin, cyclosporin A, CYSP, Sandimmune
Given PO or IV
Also known as: Cellcept, MMF
Response conversion rate (PD/SD to PR and CR)
Calculated along with 95% confidence intervals (CI). Logistic regression will be used to assess the impact of patient characteristics (e.g., low/high lactate dehydrogenase isoenzyme-3 \[LDH\] or immunologic correlates) on the response conversion rate.
Time frame: Up to 60 days post-transplant
Time to engraftment/chimerism
Estimated using the method of Kaplan and Meier. Comparison of time-to-event endpoints by important subgroups of patients will be made using the logrank test. Cox (proportional hazards) regression will be used to evaluate multivariable predictive models of time-to-event outcomes when proper.
Time frame: Up to 3 years
Rate of acute GVHD
Time frame: Up to day 730
Rate of chronic GVHD
Time frame: Up to day 730
Overall survival
Estimated using the method of Kaplan and Meier. Comparison of time-to-event endpoints by important subgroups of patients will be made using the logrank test. Cox (proportional hazards) regression will be used to evaluate multivariable predictive models of time-to-event outcomes when proper.
Time frame: Up to day 730
EFS
Comparison of time-to-event endpoints by important subgroups of patients will be made using the logrank test. Cox (proportional hazards) regression will be used to evaluate multivariable predictive models of time-to-event outcomes when proper.
Time frame: 2 years
Toxicities
Toxicities as measured by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events v4.0
Time frame: Up to day 730
This study is status unknown, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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Joseph Tuscano