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NCT01678443 · REGISTRY CONDITION SEARCH

Monoclonal Antibody Therapy Before Stem Cell Transplant in Treating Patients With Relapsed or Refractory Lymphoid Malignancies

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

Phase
PHASE1
Status at capture
TERMINATED
Registry last update
2021-04-02

This phase I trial studies the side effects and best dose of monoclonal antibody therapy before stem cell transplant in treating patients with relapsed or refractory lymphoid malignancies. Radiolabeled monoclonal antibodies, such as yttrium-90 anti-CD45 monoclonal antibody BC8, 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. Giving radiolabeled monoclonal antibody before a stem cell transplant may be an effective treatment for relapsed or refractory lymphoid malignancies.

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

Percentage of Participants With Dose Limiting Toxicities (DLT) of Yttrium-90 Anti-CD45

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outcome · POSTED

Overall Response Rate

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outcome · POSTED

Overall Survival

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outcome · POSTED

Progression-free Survival

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outcome · POSTED

Tumor to Normal Organ Ratios

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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 B-NHL, T-NHL, or HL; only patients with classical HL must have documented histologic demonstration of CD45+ cells adjacent to the Reed Sternberg cells; patients must have received at least one prior standard systemic therapy with documented recurrent or refractory disease; patients with mantle cell lymphoma (MCL), T-NHL, or other high-risk malignancies may be enrolled/transplanted in complete remission (CR)/first partial remission (PR1) * Creatinine \< 2.0 * Bilirubin \< 1.5 mg/dL * All patients eligible for therapeutic study must have a minimum of \>= 2 x 10\^6 CD34/kg autologous hematopoietic stem cells harvested and cryopreserved * Patients must have an expected survival of \> 60 days and must be free of major infection * Patients are preferred to have either a tumor mass amenable to core needle biopsy during the dosimetry phase, or a measurable tumor mass with at least one site of involvement measuring 2.5 cm in largest dimension on computed tomography (CT) imaging for purposes of planar and/or single-photon emission computed tomography (SPECT)/CT tumor dosimetry Exclusion Criteria: * Circulating human anti-mouse antibody (HAMA), to be determined before each infusion * Systemic anti-lymphoma therapy given in the previous 30 days before the scheduled therapy dose with the exception of rituximab * Inability to understand or give an informed consent * Lymphoma involving the central nervous system * Other serious medical conditions considered to represent contraindications to ASCT (e.g., abnormally decreased cardiac ejection fraction, diffusion capacity of the lung for carbon monoxide \[DLCO\] \< 50% predicted, acquired immune deficiency syndrome \[AIDS\], etc.) * Known human immunodeficiency virus (HIV) seropositivity * Pregnancy or breast feeding * Prior allogeneic bone marrow or stem cell transplant * Prior autologous bone marrow or stem cell transplant within 1 year of enrollment * Prior radiation therapy (RT) \> 20 Gray (Gy) to a critical organ within 1 year of enrollment * Southwest Oncology Group (SWOG) performance status \>= 2.0 * Patients with relapsed diffuse large B-cell lymphoma (DLBCL) or HL that have achieved a positron emission tomography (PET)-negative CR following first salvage chemotherapy
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Patients receive indium-111 anti-CD45 monoclonal antibody BC8 IV on day -28 and (if necessary) day -21. Patients receive yttrium-90 anti-CD45 monoclonal antibody BC8 IV on day -28, -14, and -13. Patients then undergo autologous peripheral blood stem cell transplantation on day 0.
    intervention Names
    1. Biological: indium In 111 anti-CD45 monoclonal antibody BC8
    2. Radiation: yttrium Y 90 anti-CD45 monoclonal antibody BC8
    3. Procedure: peripheral blood stem cell transplantation
    label
    Treatment (yttrium-90 anti-CD45 monoclonal antibody BC8)
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Treatment (yttrium-90 anti-CD45 monoclonal antibody BC8)
    description
    Given IV
    name
    indium In 111 anti-CD45 monoclonal antibody BC8
    other Names
    1. In 111 MOAB BC8
    2. In 111 monoclonal antibody BC8
    3. In111 MOAB BC8
    4. indium In 111 MOAB BC8
    type
    BIOLOGICAL
  2. arm Group Labels
    1. Treatment (yttrium-90 anti-CD45 monoclonal antibody BC8)
    description
    Given IV
    name
    yttrium Y 90 anti-CD45 monoclonal antibody BC8
    other Names
    1. 90Y anti-CD45 MAb BC8
    2. 90Y anti-CD45 MoAb BC8
    type
    RADIATION
  3. arm Group Labels
    1. Treatment (yttrium-90 anti-CD45 monoclonal antibody BC8)
    description
    Undergo autologous peripheral blood stem cell transplant
    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
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
2
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    A DLT (dose limiting toxicity) is defined as a therapy-related grade III or IV Bearman (transplant) toxicity within 30 days of transplant.
    measure
    Percentage of Participants With Dose Limiting Toxicities (DLT) of Yttrium-90 Anti-CD45
    time Frame
    Up to 30 days after receiving study drug
secondary Outcomes
  1. measure
    Overall Response Rate
    time Frame
    Up to 6 years
  2. measure
    Overall Survival
    time Frame
    Up to 6 years
  3. measure
    Progression-free Survival
    time Frame
    Up to 6 years
  4. description
    Derived from dosimetry estimates coupled with the absorbed dose to normal organs based on the administered activity of 90Y.
    measure
    Tumor to Normal Organ Ratios
    time Frame
    Up to 6 years
Full study description
brief Summary
This phase I trial studies the side effects and best dose of monoclonal antibody therapy before stem cell transplant in treating patients with relapsed or refractory lymphoid malignancies. Radiolabeled monoclonal antibodies, such as yttrium-90 anti-CD45 monoclonal antibody BC8, 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. Giving radiolabeled monoclonal antibody before a stem cell transplant may be an effective treatment for relapsed or refractory lymphoid malignancies.
detailed Description
PRIMARY OBJECTIVES: I. To estimate the maximally tolerated dose (MTD) of 90Y-BC8-DOTA (anti-cluster of differentiation \[CD\]45) (yttrium-90 anti-CD45 monoclonal antibody BC8) that can be delivered prior to autologous stem cell transplantation for patients with relapsed/refractory B-cell non-Hodgkin lymphoma (B-NHL), T-cell NHL (T-NHL), and Hodgkin lymphoma (HL). SECONDARY OBJECTIVES: I. To optimize the protein dose (antibody \[Ab\]) to deliver a favorable biodistribution in the majority of patients. II. To describe the impact of rituximab concentrations, B-cell depletion, and disease burden on CD20 and CD45 targeting. III. To describe response rates and remission durations in relapsed B-NHL, T-NHL, and HL following administration of myeloablative doses of 90Y-BC8-DOTA prior to autologous stem cell transplant (ASCT). IV. To assess the correlation of lymphoma biomarkers with outcomes. OUTLINE: This is a dose-escalation study of yttrium-90 anti-CD45 monoclonal antibody BC8. Patients receive indium-111 anti-CD45 monoclonal antibody BC8 intravenously (IV) on day -28 and (if necessary) day -21 to evaluate the antibody's biodistribution. Patients then receive yttrium-90 anti-CD45 monoclonal antibody BC8 IV on day -14. Patients then undergo autologous peripheral blood stem cell transplantation on day 0. After completion of study treatment, patients are followed up at 3, 6, and 12 months and then annually thereafter.
Source references
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