Status:
COMPLETED
Radiolabeled Monoclonal Antibody and Combination Chemotherapy Before Stem Cell Transplant in Treating Patients With High-Risk Lymphoid Malignancies
Lead Sponsor:
Fred Hutchinson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Recurrent B-Cell Non-Hodgkin Lymphoma
Recurrent Hodgkin Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This phase I/II trial studies the side effects and the best dose of radiolabeled monoclonal antibody when given together with combination chemotherapy before stem cell transplant and to see how well i...
Detailed Description
PRIMARY OBJECTIVES: I. To estimate the maximum-tolerated dose (MTD) of 90Y-BC8-DOTA (yttrium Y 90 anti-CD45 monoclonal antibody BC8) (anti-cluster of differentiation \[CD\] 45) that can be delivered ...
Eligibility Criteria
Inclusion
- 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 x10\^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
Exclusion
- 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 carbon monoxide \[DLCO\] \< 50% predicted, etc.)
- Known human immunodeficiency virus (HIV) seropositivity
- Pregnancy or breast feeding
- Prior autologous or allogeneic bone marrow or stem cell transplant
- Prior radiation therapy (RT) \> 20 gray (Gy) to a critical organ within 1 year of enrollment
- Southwestern Oncology Group (SWOG) performance status \>= 2.0
Key Trial Info
Start Date :
October 9 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 26 2020
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01921387
Start Date
October 9 2013
End Date
July 26 2020
Last Update
August 4 2020
Active Locations (1)
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1
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109