Recurrent Mantle Cell Lymphoma Clinical Trial
Official title:
A Phase I Study Evaluating Escalating Doses of 90Y-BC8-DOTA (Anti-CD45) Antibody Followed by Autologous Stem Cell Transplantation for Relapsed or Refractory Lymphoid Malignancies
Verified date | March 2021 |
Source | Fred Hutchinson Cancer Research Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 2 |
Est. completion date | September 27, 2018 |
Est. primary completion date | September 21, 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
Fred Hutchinson Cancer Research Center | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of Participants With Dose Limiting Toxicities (DLT) of Yttrium-90 Anti-CD45 | A DLT (dose limiting toxicity) is defined as a therapy-related grade III or IV Bearman (transplant) toxicity within 30 days of transplant. | Up to 30 days after receiving study drug | |
Secondary | Overall Response Rate | Up to 6 years | ||
Secondary | Overall Survival | Up to 6 years | ||
Secondary | Progression-free Survival | Up to 6 years | ||
Secondary | Tumor to Normal Organ Ratios | Derived from dosimetry estimates coupled with the absorbed dose to normal organs based on the administered activity of 90Y. | Up to 6 years |
Status | Clinical Trial | Phase | |
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