NCT01811368

Zevalin Before Stem Cell Transplant in Treating Patients With Non-Hodgkin Lymphoma

Use of Zevalin to Enhance the Efficacy of Non-Myeloablative Allogeneic Transplantation in Patients With Relapsed or Refractory CD20+ Non-Hodgkin's Lymphoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Joseph Tuscano · Academic / Other
• Sex: All
• Age: 19 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Refractory Non Hodgkin Lymphoma
• Relapsed Non Hodgkin Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	rituximab	Given IV
BIOLOGICAL	ibritumomab tiuxetan	Given IV
BIOLOGICAL	anti-thymocyte globulin	Given IV
RADIATION	total nodal irradiation	Undergo TLI
PROCEDURE	peripheral blood stem cell transplantation	Undergo allogeneic peripheral blood stem cell transplant
PROCEDURE	allogeneic hematopoietic stem cell transplantation	Undergo allogeneic peripheral blood stem cell transplant
DRUG	cyclosporine	Given PO or IV
DRUG	mycophenolate mofetil	Given PO or IV

Timeline

• Start date: 2013-03-12
• Primary completion: 2023-04-01
• Completion: 2023-12-01
• First posted: 2013-03-14
• Last updated: 2022-11-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study