High-Dose Y-90-Ibritumomab Tiuxetan Added to Reduced-Intensity Allogeneic Stem Cell Transplant Regimen for Relapsed or Refractory Aggressive B-Cell Lymphoma
NCT ID: NCT01434472
Last Updated: 2021-07-20
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
20 participants
INTERVENTIONAL
2011-11-16
2020-05-06
Brief Summary
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Detailed Description
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I. To assess the safety and efficacy of 1.5 mCi/kg (max 120 mCi) 90Y-Ibritumomab tiuxetan (yttrium Y 90 ibritumomab tiuxetan) (anti-CD20) combined with fludarabine (fludarabine phosphate) (30 mg/m\^2 x 3) and 2 gray (Gy) total body irradiation followed by human leukocyte antigens (HLA) matched allogeneic hematopoietic transplantation for patients with relapsed or refractory aggressive B-cell lymphoma.
OUTLINE:
Beginning 24-48 hours prior to therapy infusion, patients receive rituximab intravenously (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 orally (PO) twice daily (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 thrice daily (TID) on days 0-40 with taper to day 96 (unrelated donor).
After completion of study treatment and assessments through \~day 100 following transplant, patients are followed up at 1, 3, 6, and 12 months and then annually up to 2 years thereafter.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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).
Allogeneic Hematopoietic Stem Cell Transplantation
Undergo allogeneic PBSCT (infusion of donor stem cells via central catheter)
Cyclosporine
Given PO
Fludarabine Phosphate
Given IV
Indium In-111 Ibritumomab Tiuxetan
Given IV
Mycophenolate Mofetil
Given PO
Pharmacological Study
Correlative studies
Rituximab
Given IV prior to yttrium Y 90 ibritumomab tiuxetan
Total-Body Irradiation
Undergo TBI
Yttrium Y-90 Ibritumomab Tiuxetan
Given IV
Fludarabine
Given IV
Interventions
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Allogeneic Hematopoietic Stem Cell Transplantation
Undergo allogeneic PBSCT (infusion of donor stem cells via central catheter)
Cyclosporine
Given PO
Fludarabine Phosphate
Given IV
Indium In-111 Ibritumomab Tiuxetan
Given IV
Mycophenolate Mofetil
Given PO
Pharmacological Study
Correlative studies
Rituximab
Given IV prior to yttrium Y 90 ibritumomab tiuxetan
Total-Body Irradiation
Undergo TBI
Yttrium Y-90 Ibritumomab Tiuxetan
Given IV
Fludarabine
Given IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients must have relapsed after high-dose therapy and autologous transplantation or be ineligible for high-dose therapy and autologous transplantation; patients that have failed autologous transplantation are those with persistent disease \> 30 days after transplant; those ineligible for autologous transplant include those with chemoresistant disease (i.e., patients who have not achieved a partial response or better with their most recent chemotherapy regimen), are expected to have a poor outcome from autologous transplant (e.g., DLBCL relapsing within one year of rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, prednisone \[R-CHOP\]-like chemotherapy, double hit lymphoma, v-myc myelocytomatosis viral oncogene homolog (avian) positive \[MYC+\] lymphoma, persistent positron emission tomography \[PET\] positivity after chemotherapy), are unable to collect sufficient or tumor-free autologous stem cells per Seattle Cancer Care Alliance (SCCA) standard practice, are unable to tolerate the high-dose autologous conditioning regimens, or who refuse a high-dose autologous transplant regimen
* Creatinine (Cr) \< 2.0
* Bilirubin \< 1.5 mg/dL with the exception of patients thought to have Gilbert's syndrome, who may have a total bilirubin above 1.5 mg/dL
* Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) \< 3 x upper limit of normal (ULN)
* Patients must have an expected survival without treatment of \> 60 days and must be free of major infection including human immunodeficiency virus (HIV)
* Patients must have an HLA-identical related or HLA-matched unrelated donor
Exclusion Criteria
* \< 30 days for intravenously-administered cytotoxic chemotherapy and/or monoclonal antibodies
* \< 5 half-lives for all other anti-cancer agents (e.g., targeted therapies, corticosteroids, immunomodulatory agents, etc.)
* Inability to understand or give an informed consent
* Active central nervous system lymphoma
* Pregnancy
* Fertile men or women unwilling to use contraceptive techniques during and for 12 months following treatment
* Southwest Oncology Group (SWOG)/Eastern Cooperative Oncology Group (ECOG) performance score \>= 2
* High-dose chemotherapy or external beam radiation therapy to lung, liver, or kidneys \> 20 Gy within the previous 100 days prior to therapeutic 90Y-ibritumomab tiuxetan dose
* Medical condition that would contraindicate allogeneic transplantation as per standard practice guidelines (e.g., impaired cardiopulmonary function, hepatitis, etc)
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Fred Hutchinson Cancer Center
OTHER
Responsible Party
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Ajay Gopal
Professor
Principal Investigators
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Ajay Gopal
Role: PRINCIPAL_INVESTIGATOR
Fred Hutch/University of Washington Cancer Consortium
Locations
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Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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NCI-2011-01189
Identifier Type: REGISTRY
Identifier Source: secondary_id
2398.00
Identifier Type: OTHER
Identifier Source: secondary_id
RG9213033
Identifier Type: OTHER
Identifier Source: secondary_id
2398.00
Identifier Type: -
Identifier Source: org_study_id
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