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NCT00119392 · REGISTRY CONDITION SEARCH

Yttrium Y 90 Ibritumomab Tiuxetan, Fludarabine, Radiation Therapy, and Donor Stem Cell Transplant in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE2
Status at capture
COMPLETED
Registry last update
2018-06-29

Monoclonal antibodies, such as yttrium Y 90 ibritumomab tiuxetan, can block find cancer cells and either kill them or carry cancer-killing substances to them without harming normal cells. Giving monoclonal antibodies, low doses of chemotherapy, such as fludarabine phosphate, and low dose total-body radiation therapy before a donor peripheral stem cell transplant helps stop the growth of cancer cells and also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine or mycophenolate mofetil after the transplant may stop this from happening

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Treatment Related Mortality (TRM)

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outcome · POSTED

Overall and Progression-free Survival

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outcome · POSTED

Response Rates

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outcome · POSTED

Engraftment and Hematopoietic Toxicity

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outcome · POSTED

Incidence and Severity of Acute Graft-versus-host Disease (GVHD) and Chronic GVHD.

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
Inclusion Criteria: * Patients must have a histologically confirmed diagnosis of a lymphoid malignancy expressing the cluster of differentiation (CD)20 antigen and have failed at least one prior standard systemic therapy * Patients must have evidence of persistent lymphoma by physical examination, radiographic studies, bone marrow evaluation, flow cytometry, or polymerase chain reaction (PCR) * Creatinine \< 2.0 * Bilirubin \< 1.5 mg/dL * Patients must have an expected survival of \> 60 days and must be free of major infection including human immunodeficiency virus (HIV) * Patients must have an HLA-identical related or unrelated donor * DONOR: Donor eligibility includes both HLA-matched relatives or HLA matched, unrelated volunteer donors; related donors should be matched by molecular methods at the intermediate resolution level at HLA-A, B, C, and DRB1 according to FHCRC Standard Practice Guidelines and to the allele level at DQB1; unrelated donors should be identified using matching criteria that follows the FHCRC Standard Practice Guidelines limiting the study to eligible donors that are allele matched for HLA-A, B, C, DRB1, and DQB1 (Grade1), and accepting up to one allele mismatch as per Standard Practice Grade 2.1 for HLA-A, B, or C * Donor must consent to granulocyte colony-stimulating factor (G-CSF) (filgrastim) administration and leukapheresis * Donor must have adequate veins for leukapheresis or agree to placement of central venous catheter (femoral, subclavian) Exclusion Criteria: * Systemic anti-lymphoma therapy given in the previous 30 days * Patients who have experienced progressive disease within 3 months of prior Bexxar or Zevalin * Inability to understand or give an informed consent * 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 * Eligible for radioimmunotherapy-based autologous transplant trial * Medical condition that would contraindicate allogeneic transplantation * Evidence of Human Anti-Mouse Antibody (HAMA) for patients with prior exposure to therapeutic murine antibodies * Eligible for other therapeutic options that will be more likely to have a better long-term disease-free survival with lower potential toxicity (e.g., non-transplant therapy, autologous transplants, etc.) than this study * Other grave medical conditions considered to represent contraindications to bone marrow transplant (BMT) (e.g. unstable angina, pulmonary dysfunction \[diffusing capacity of the lung for carbon monoxide (DLCO) \< 30%, total lung capacity (TLC) \< 30%, continuous supplemental oxygen\], acquired immune deficiency syndrome \[AIDS\], etc.) * DONOR: Identical twin * DONOR: Age less than 12 years * DONOR: Pregnancy * DONOR: Infection with HIV * DONOR: Inability to achieve adequate venous access * DONOR: Known allergy to G-CSF * DONOR: Current serious systemic illness or infection
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    See Detailed Description
    intervention Names
    1. Biological: rituximab
    2. Drug: cyclosporine
    3. Drug: fludarabine phosphate
    4. Drug: mycophenolate mofetil
    5. Radiation: yttrium Y 90 ibritumomab tiuxetan
    6. Procedure: peripheral blood stem cell transplantation
    7. Procedure: allogeneic hematopoietic stem cell transplantation
    8. Radiation: total-body irradiation
    label
    Treatment (90Y ibritumomab tiuxetan, hematopoietic transplant)
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Treatment (90Y ibritumomab tiuxetan, hematopoietic transplant)
    description
    Given IV
    name
    rituximab
    other Names
    1. IDEC-C2B8
    2. IDEC-C2B8 monoclonal antibody
    3. Mabthera
    4. MOAB IDEC-C2B8
    5. Rituxan
    type
    BIOLOGICAL
  2. arm Group Labels
    1. Treatment (90Y ibritumomab tiuxetan, hematopoietic transplant)
    description
    Given orally
    name
    cyclosporine
    other Names
    1. ciclosporin
    2. cyclosporin
    3. cyclosporin A
    4. CYSP
    5. Sandimmune
    type
    DRUG
  3. arm Group Labels
    1. Treatment (90Y ibritumomab tiuxetan, hematopoietic transplant)
    description
    Given IV
    name
    fludarabine phosphate
    other Names
    1. 2-F-ara-AMP
    2. Beneflur
    3. Fludara
    type
    DRUG
  4. arm Group Labels
    1. Treatment (90Y ibritumomab tiuxetan, hematopoietic transplant)
    description
    Given orally
    name
    mycophenolate mofetil
    other Names
    1. Cellcept
    2. MMF
    type
    DRUG
  5. arm Group Labels
    1. Treatment (90Y ibritumomab tiuxetan, hematopoietic transplant)
    description
    Given IV
    name
    yttrium Y 90 ibritumomab tiuxetan
    other Names
    1. 90Y ibritumomab tiuxetan
    2. IDEC Y2B8
    3. Y90 Zevalin
    4. Y90-labeled ibritumomab tiuxetan
    type
    RADIATION
  6. arm Group Labels
    1. Treatment (90Y ibritumomab tiuxetan, hematopoietic transplant)
    description
    Undergo transplantation
    name
    peripheral blood stem cell transplantation
    other Names
    1. PBPC transplantation
    2. PBSC transplantation
    3. peripheral blood progenitor cell transplantation
    4. transplantation, peripheral blood stem cell
    type
    PROCEDURE
  7. arm Group Labels
    1. Treatment (90Y ibritumomab tiuxetan, hematopoietic transplant)
    description
    Undergo transplantation
    name
    allogeneic hematopoietic stem cell transplantation
    type
    PROCEDURE
  8. arm Group Labels
    1. Treatment (90Y ibritumomab tiuxetan, hematopoietic transplant)
    description
    Undergo TBI
    name
    total-body irradiation
    other Names
    1. TBI
    type
    RADIATION
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
42
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Cumulative incidence rate of treatment related mortality with relapse as a competing risk, assessed at 30 months.
    measure
    Treatment Related Mortality (TRM)
    time Frame
    At day +100
secondary Outcomes
  1. description
    Kaplan-Meier estimates for overall survival (OS) and progression free survival (PFS) assessed at two years.
    measure
    Overall and Progression-free Survival
    time Frame
    Up to 8 years
  2. measure
    Response Rates
    time Frame
    Up to 8 years
  3. description
    Median number of days after transplantation to a neutrophil count less than 500 neutrophils per microliter and a platelet count less than 50,000 platelets per microliter.
    measure
    Engraftment and Hematopoietic Toxicity
    time Frame
    At day +100
  4. measure
    Incidence and Severity of Acute Graft-versus-host Disease (GVHD) and Chronic GVHD.
    time Frame
    At day +84
Full study description
brief Summary
Monoclonal antibodies, such as yttrium Y 90 ibritumomab tiuxetan, can block find cancer cells and either kill them or carry cancer-killing substances to them without harming normal cells. Giving monoclonal antibodies, low doses of chemotherapy, such as fludarabine phosphate, and low dose total-body radiation therapy before a donor peripheral stem cell transplant helps stop the growth of cancer cells and also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine or mycophenolate mofetil after the transplant may stop this from happening
detailed Description
PRIMARY OBJECTIVES: I. To assess the feasibility, safety, and potential efficacy of treating patients with B-Cell non-Hodgkin lymphoma (NHL) with 90Y-ibritumomab tiuxetan, combined with HLA-matched related or unrelated donor hematopoietic cell transplantation. OUTLINE: Patients receive rituximab intravenously (IV) followed by, no more than 4 hours later, indium In 111 ibritumomab tiuxetan (for imaging) IV over 10 minutes on day -21. Patients undergo gamma camera imaging on day -19. Patients receive rituximab IV followed by, no more than 4 hours later, yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day -14. Patients also receive fludarabine phosphate IV over 30-60 minutes on days -7 to -5 and undergo low-dose total-body irradiation (TBI) on day 0. After TBI, patients undergo allogeneic peripheral blood stem cell transplantation (PBSCT) on day 0. Patients who undergo PBSCT from a related donor receive oral cyclosporine twice daily on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease (GVHD). These patients also receive oral mycophenolate mofetil twice daily on days 0 to 27. Patients who undergo PBSCT from an unrelated donor receive oral cyclosporine twice daily on days -3 to 100 followed by a taper over 11 weeks in the absence of GVHD. These patients also receive oral mycophenolate mofetil three times daily on days 0 to 40 followed by a taper to day 96. After completion of study treatment, patients are followed up at 1, 3, 6, and 12 months, and then annually thereafter.
Source references
references
  1. citation
    Puronen CE, Cassaday RD, Stevenson PA, Sandmaier BM, Flowers ME, Green DJ, Maloney DG, Storb RF, Press OW, Gopal AK. Long-Term Follow-Up of 90Y-Ibritumomab Tiuxetan, Fludarabine, and Total Body Irradiation-Based Nonmyeloablative Allogeneic Transplant Conditioning for Persistent High-Risk B Cell Lymphoma. Biol Blood Marrow Transplant. 2018 Nov;24(11):2211-2215. doi: 10.1016/j.bbmt.2018.06.033. Epub 2018 Jul 3.
    pmid
    30454872
    type
    DERIVED
  2. citation
    Gopal AK, Guthrie KA, Rajendran J, Pagel JM, Oliveira G, Maloney DG, Matesan MC, Storb RF, Press OW. (9)(0)Y-Ibritumomab tiuxetan, fludarabine, and TBI-based nonmyeloablative allogeneic transplantation conditioning for patients with persistent high-risk B-cell lymphoma. Blood. 2011 Jul 28;118(4):1132-9. doi: 10.1182/blood-2010-12-324392. Epub 2011 Apr 20.
    pmid
    21508413
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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    Preserved source evidence · Not medical advice