High-Dose Y-90-Ibritumomab Tiuxetan Added to Reduced-Intensity Allogeneic Stem Cell Transplant Regimen for Relapsed or Refractory Aggressive B-Cell Lymphoma

Part of paid clinical trials in Seattle, Washington.

Sponsor
Fred Hutchinson Cancer Center
Study ID
NCT01434472
Phase
PHASE2
Status
Terminated

Conditions

  • Post-Transplant Lymphoproliferative Disorder
  • Recurrent Adult Diffuse Large Cell Lymphoma
  • Recurrent B-Cell Non-Hodgkin Lymphoma
  • Recurrent Burkitt Lymphoma
  • Refractory B-Cell Non-Hodgkin Lymphoma
  • Refractory Burkitt Lymphoma
  • Refractory Diffuse Large B-Cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Allogeneic Hematopoietic Stem Cell Transplantation — PROCEDURE
    Undergo allogeneic PBSCT (infusion of donor stem cells via central catheter)
  • Cyclosporine — DRUG
    Given PO
  • Fludarabine Phosphate — DRUG
    Given IV
  • Indium In-111 Ibritumomab Tiuxetan — RADIATION
    Given IV
  • Mycophenolate Mofetil — DRUG
    Given PO
  • Pharmacological Study — OTHER
    Correlative studies
  • Rituximab — BIOLOGICAL
    Given IV prior to yttrium Y 90 ibritumomab tiuxetan
  • Total-Body Irradiation — RADIATION
    Undergo TBI
  • Yttrium Y-90 Ibritumomab Tiuxetan — RADIATION
    Given IV
  • Fludarabine — DRUG
    Given IV

Study Details

This phase II trial studies the side effects and how well high-dose yttrium-90 (Y-90)-ibritumomab tiuxetan (anti-cluster of differentiation \[CD\]20) followed by fludarabine phosphate, low-dose total body irradiation (TBI), and donor peripheral blood stem cell transplant (PBSCT) work in treating patients with aggressive B-cell lymphoma that has returned after a period of improvement (relapsed) or has not responded to previous treatment (refractory). Radiolabeled monoclonal antibodies, such as Y-90-ibritumomab tiuxetan, can find cancer cells and carry cancer-killing substances to them with less effect on normal cells. Giving chemotherapy, such as fludarabine phosphate, and TBI before a donor PBSCT helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. However, high-dose radiolabeled antibodies also destroy healthy blood cells in the patient's body. When healthy stem cells from a donor are infused into the patient (stem cell transplant), they may help the patient's body replace these blood cells. Giving high-dose Y-90-ibritumomab tiuxetan followed by fludarabine phosphate, TBI, and donor PBSCT may be an effective treatment for patients with B-cell lymphoma.

Key Dates

Start date
Nov 16, 2011
Status verified
Jul 2021
Primary completion
May 6, 2020
Completion
May 6, 2020

Study Design

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

Arms

  • Experimental: Treatment (radiolabeled antibody, TBI, allogeneic PBSCT)
    Beginning 24-48 hours prior to therapy infusion, patients receive rituximab IV over 4-6 hours and then receive a therapy-dose of high-dose yttrium Y 90 ibritumomab tiuxetan IV over 30 minutes on day -14 prior to transplant. Patients also receive fludarabine phosphate IV on days -4 to -2 and undergo TBI followed by allogeneic PBSCT on day 0. Patients also receive cyclosporine PO BID on days -3 to 56 with taper to day 180 (related donor) or -3 to 100 with taper over 11 weeks (unrelated donor) and mycophenolate mofetil PO BID on days 0-27 (related donor) or PO TID on days 0-40 with taper to day 96 (unrelated donor).

Primary Outcome Measure

Progression-free Survival [ Time Frame: 1 year ]

Locations (1)

FacilityCityStateZIPSite coordinators
Fred Hutch/University of Washington Cancer ConsortiumSeattleWashington98109-

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By research site
Fred Hutch/University of Washington Cancer Consortium· Seattle, WA

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