Yttrium Y 90 Basiliximab and Combination Chemotherapy Before Stem Cell Transplant in Treating Patients With Mature T-cell Non-Hodgkin Lymphoma
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|ClinicalTrials.gov Identifier: NCT02342782|
Recruitment Status : Active, not recruiting
First Posted : January 21, 2015
Last Update Posted : June 23, 2020
|Condition or disease||Intervention/treatment||Phase|
|Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma Recurrent Mature T- and NK-Cell Non-Hodgkin Lymphoma Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma Recurrent Cutaneous T-Cell Non-Hodgkin Lymphoma Refractory Cutaneous T-Cell Non-Hodgkin Lymphoma||Biological: Yttrium Y 90 Basiliximab Drug: Carmustine Drug: Etoposide Drug: Cytarabine Drug: Melphalan Procedure: Autologous Hematopoietic Stem Cell Transplantation Other: Laboratory Biomarker Analysis Other: Pharmacological Study||Phase 1|
I. To determine if administration of 90Y-basiliximab/DOTA (yttrium Y 90 basiliximab), when given in combination with standard dose BEAM, as conditioning for autologous hematopoietic cell transplant (AHCT), is safe, by evaluation of toxicities, including type, frequency, severity, attribution, time course and duration.
II. To determine the maximum tolerated dose (MTD) of 90Y-basiliximab/DOTA when given in combination with standard dose BEAM, in patients with T-cell non-Hodgkin lymphoma (T-NHL) as part of conditioning for AHCT.
I. To characterize and evaluate hematologic recovery in terms of neutrophil and platelet engraftment time.
II. To estimate radiation doses to the whole body and normal organs through serial imaging studies.
III. To estimate overall survival, progression-free survival, non-relapse mortality and cumulative incidence of relapse/progression at 100-days (non-relapse mortality [NRM] only), 1-year and 2-years.
OUTLINE: This is a dose-escalation study of yttrium Y 90 basiliximab.
Patients receive yttrium Y 90 basiliximab intravenously (IV) on days -21 and -14, carmustine IV over 1-2 hours on days -7 and -6, cytarabine IV twice daily (BID) on days -5 to -2, etoposide IV BID on days -5 to -2, and melphalan IV on day -1. Patients undergo autologous hematopoietic stem cell transplant on day 0.
After completion of study treatment, patients are followed up at 30, 100, and 180 days and 1, 1.5, and 2 years.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Study of Yttrium-90 Labeled Anti-CD25 Monoclonal Antibody Plus Standard BEAM Conditioning for Autologous Hematopoietic Cell Transplantation in Patients With Mature T-Cell Non-Hodgkin Lymphoma: the aTAC BEAM Regimen|
|Study Start Date :||June 8, 2015|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
Experimental: Treatment (yttrium Y 90 basiliximab, BEAM, AHCT)
Patients receive yttrium Y 90 basiliximab IV on days -21 and -14, carmustine IV over 1-2 hours on days -7 and -6, cytarabine IV BID on days -5 to -2, etoposide IV BID on days -5 to -2, and melphalan IV on day -1. Patients undergo autologous hematopoietic stem cell transplant on day 0.
Biological: Yttrium Y 90 Basiliximab
Other Name: 90Y Basiliximab
Procedure: Autologous Hematopoietic Stem Cell Transplantation
Other Name: Autologous Stem Cell Transplantation
Other: Laboratory Biomarker Analysis
Other: Pharmacological Study
Other Name: pharmacological studies
- MTD of yttrium Y 90 basiliximab defined as the highest dose in which fewer than 33% of patients experience dose limiting toxicity attributable to study treatment, among those evaluable for toxicity [ Time Frame: 30 days post-transplant ]Dose limiting toxicities will be graded by the Modified Bearman scale.
- Incidence of toxicities assessed using National Cancer Institute (NCI) CTCAE version 4.03 [ Time Frame: Up to 100 days post-transplant ]Observed toxicities will be summarized by type (organ affected or laboratory determination such as absolute neutrophil count), severity (by NCI CTCAE version 4.03 and nadir or maximum values for lab measures), date of onset, duration, reversibility, and attribution.
- Disease response by Cheson 2007 criteria [ Time Frame: Up to 2 years post-transplant ]
- Engraftment: neutrophil and platelet recovery [ Time Frame: Up to 2 years post-transplant ]
- Overall survival [ Time Frame: From start of therapy (stem cell infusion) to death from any cause, assessed up to 2 years post-transplant ]Survival estimates will be calculated using the Kaplan-Meier method.
- Progression-free survival [ Time Frame: From start of therapy (stem cell infusion) to the first observation of disease relapse/progression or death from any cause, assessed up to 2 years post-transplant ]Survival estimates will be calculated using the Kaplan-Meier method.
- Non-relapse mortality [ Time Frame: From start of therapy until non-disease related death, or last follow-up, whichever comes first, assessed up to 2 years post-transplant ]The cumulative incidence of relapse/progression and non-relapse mortality will be calculated as competing risks using the Gray method.
- Cumulative incidence of relapse/progression [ Time Frame: From start of therapy (stem cell infusion) to the first observation of disease relapse/progression, assessed up to 2 years post-transplant ]The cumulative incidence of relapse/progression and non-relapse mortality will be calculated as competing risks using the Gray method.
- Absorbed radiation dose to organs assessed by nuclear scan images [ Time Frame: Up to day -14 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02342782
|United States, California|
|City of Hope Medical Center|
|Duarte, California, United States, 91010|
|Principal Investigator:||Jasmine Zain, MD||City of Hope Medical Center|