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

Part of paid clinical trials in Sacramento, California.

Sponsor
Joseph Tuscano
Study ID
NCT01811368
Phase
PHASE2
Status
Unknown

Conditions

  • Refractory Non Hodgkin Lymphoma
  • Relapsed Non Hodgkin Lymphoma

Eligibility Criteria

Sex
ALL
Age
19 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Mar 12, 2013
Status verified
Nov 2022
Primary completion
Apr 30, 2023
Completion
Dec 31, 2023

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (ibritumomab tiuxetan, allogeneic PBSCT)
    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.

Primary Outcome Measure

Response conversion rate (PD/SD to PR and CR) [ Time Frame: Up to 60 days post-transplant ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of California DavisSacramentoCalifornia95817-

Find similar trials in Sacramento, CA

By research site
University of California Davis· Sacramento, CA

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