Anti-CD20 Radioimmunotherapy Before Chemotherapy and Stem Cell Transplant in Treating Patients With High-Risk B-Cell Malignancies
NCT ID: NCT02483000
Last Updated: 2020-11-23
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE1
3 participants
INTERVENTIONAL
2017-02-01
2020-09-02
Brief Summary
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Detailed Description
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I. To estimate the maximum tolerated dose (MTD) of 90Y activity that can be delivered via pretargeted radioimmunotherapy (PRIT) using B9E9-fusion protein (B9E9-FP), clearing agent (CA), and radiolabeled tetraazacyclododecane-1,4,7,10-tetraacetic acid (DOTA)-biotin when followed by carmustine, etoposide, cytarabine, and melphalan (BEAM) chemotherapy and autologous stem cell transplantation.
SECONDARY OBJECTIVES:
I. To assess the overall and progression-free survival of the above regimen in such patients.
II. To evaluate the response rates of the above therapy.
III. To evaluate the toxicity and tolerability of the above therapy.
IV. To evaluate the feasibility of delivering sequential high-dose PRIT and chemotherapy.
TERTIARY OBJECTIVES:
I. Assess biodistribution and pharmacokinetics of B9E9-FP and radiolabeled DOTA-Biotin.
II. Assess ability of the clearing agent (CA) to remove excess B9E9-FP from the serum.
III. Evaluate the impact, if any, of circulating rituximab on biodistributions.
OUTLINE: This is a phase I, dose-escalation study of yttrium Y 90 DOTA-biotin followed by a phase II study.
B9E9-FP INFUSION: Patients receive B9E9-fusion protein intravenously (IV) over a minimum of 2 hours on day -17.
CLEARING AGENT INFUSION: Patients receive clearing agent IV over a minimum of 30 minutes on day -15.
RADIOBIOTIN INFUSION: Patients receive indium In 111-DOTA-biotin IV and yttrium Y 90 DOTA-biotin IV over 2-5 minutes on day -14.
BEAM CHEMOTHERAPY: Patients receive BEAM chemotherapy comprising carmustine IV over 3 hours on day -7; etoposide IV over 2 hours twice daily (BID) and cytarabine IV over 4 hours BID on days -6 to -3; and melphalan IV over 30 minutes on day -2.
STEM CELL INFUSION: Patients undergo autologous peripheral blood stem cell transplant (PBSCT) on day 0 per standard of care.
After completion of study treatment, patients are followed up at 1, 3, 6, and 12 months, and then annually thereafter.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment (PRIT)
B9E9-FP INFUSION: Patients receive B9E9-fusion protein IV over a minimum of 2 hours on day -17.
CLEARING AGENT INFUSION: Patients receive clearing agent IV over a minimum of 30 minutes on day -15.
RADIOBIOTIN INFUSION: Patients receive indium In 111-DOTA-biotin IV and yttrium Y 90 DOTA-biotin IV over 2-5 minutes on day -14.
BEAM CHEMOTHERAPY: Patients receive BEAM chemotherapy comprising carmustine IV over 3 hours on day -7; etoposide IV over 2 hours BID and cytarabine IV over 4 hours BID on days -6 to -3; and melphalan IV over 30 minutes on day -2.
STEM CELL INFUSION: Patients undergo autologous PBSCT on day 0 per standard of care.
Anti-CD20 B9E9 scFv-Streptavidin Fusion Protein
Given IV
Autologous Hematopoietic Stem Cell Transplantation
Undergo autologous PBSCT
Carmustine
Given IV
Clearing Agent
Given IV
Cytarabine
Given IV
Etoposide
Given IV
Indium In 111-DOTA-Biotin
Given IV
Laboratory Biomarker Analysis
Correlative studies
Melphalan
Given IV
Peripheral Blood Stem Cell Transplantation
Undergo autologous PBSCT
Pharmacological Study
Correlative studies
Yttrium Y 90-DOTA-Biotin
Given IV
Interventions
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Anti-CD20 B9E9 scFv-Streptavidin Fusion Protein
Given IV
Autologous Hematopoietic Stem Cell Transplantation
Undergo autologous PBSCT
Carmustine
Given IV
Clearing Agent
Given IV
Cytarabine
Given IV
Etoposide
Given IV
Indium In 111-DOTA-Biotin
Given IV
Laboratory Biomarker Analysis
Correlative studies
Melphalan
Given IV
Peripheral Blood Stem Cell Transplantation
Undergo autologous PBSCT
Pharmacological Study
Correlative studies
Yttrium Y 90-DOTA-Biotin
Given IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* All patients eligible for therapeutic study must have (\>= 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 of childbearing potential must agree to abstinence or the use of effective contraception
* DONOR SELECTION: Not applicable; this protocol employs autologous transplantation, utilizing the patient?s own hematopoietic stem cells obtained from either the peripheral blood or bone marrow
Exclusion Criteria
* Inability to understand or give an informed consent
* Prior radiation \> 20 Gy to any critical normal organ (e.g., lung, liver, spinal cord, both kidneys) within 1 year of the treatment date
* Active central nervous system lymphoma
* Other serious medical conditions considered to represent contraindications to bone marrow transplant (BMT) (e.g., abnormally decreased cardiac ejection fraction, diffusion capacity of the lung for carbon monoxide \[DLCO\] \< 50% predicted, patient on supplemental oxygen, acquired immune deficiency syndrome \[AIDS\], etc.)
* Pregnancy or breast feeding
* Prior bone marrow or stem cell transplant
* Southwest Oncology Group (SWOG) performance status \>= 2.0
* Known sensitivity to kanamycin and other aminoglycosides; patients with known hypersensitivity to kanamycin or any other aminoglycoside antibiotic will be excluded
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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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-2015-00299
Identifier Type: REGISTRY
Identifier Source: secondary_id
9189
Identifier Type: OTHER
Identifier Source: secondary_id
9189
Identifier Type: -
Identifier Source: org_study_id