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Monoclonal Antibodies
Radioimmunotherapy + Chemotherapy Before Stem Cell Transplant for T-Cell Lymphoma
Phase 1
Waitlist Available
Led By Jasmine Zain, MD
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years post-transplant
Awards & highlights
Study Summary
This trial is testing the side effects and best dose of yttrium Y 90 basiliximab when given with standard combination chemotherapy before a stem cell transplant, in order to treat patients with mature T-cell non-Hodgkin lymphoma.
Who is the study for?
This trial is for patients with mature T-cell non-Hodgkin lymphoma who can undergo high-dose therapy and stem cell transplant. They must have a Karnofsky status of at least 70%, agree to use contraception, have adequate organ function, and collected enough stem cells for the procedure. Excluded are those with prior transplants, uncontrolled illnesses, certain allergies or previous treatments that might interfere.Check my eligibility
What is being tested?
The trial tests yttrium Y 90 basiliximab combined with BEAM chemotherapy before autologous hematopoietic stem cell transplantation in treating mature T-cell non-Hodgkin lymphoma. It aims to determine the side effects and best dose of this radioimmunotherapy approach.See study design
What are the potential side effects?
Potential side effects include reactions related to radiation exposure from yttrium Y 90 basiliximab such as fatigue, nausea, and lowered blood counts. Chemotherapy may cause hair loss, mouth sores, increased risk of infection due to low blood cell counts, and possible damage to organs.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years post-transplant
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years post-transplant
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of toxicities assessed using National Cancer Institute (NCI) CTCAE version 4.03
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
Secondary outcome measures
Absorbed radiation dose to organs assessed by nuclear scan images
Cumulative incidence of relapse/progression
Disease response by Cheson 2007 criteria
+4 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (yttrium Y 90 basiliximab, BEAM, AHCT)Experimental Treatment8 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carmustine
1990
Completed Phase 3
~1790
Etoposide
2010
Completed Phase 3
~2440
Cytarabine
2016
Completed Phase 3
~3310
Melphalan
2008
Completed Phase 3
~1500
Autologous Hematopoietic Stem Cell Transplantation
2017
Completed Phase 3
~1730
Find a Location
Who is running the clinical trial?
City of Hope Medical CenterLead Sponsor
565 Previous Clinical Trials
1,921,440 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,133 Total Patients Enrolled
Jasmine Zain, MDPrincipal InvestigatorCity of Hope Medical Center
1 Previous Clinical Trials
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your disease is getting worse.If you are pregnant, you cannot participate in this study. If you are currently breastfeeding and will be receiving treatment with indium In 111 (111In-) and 90Y-basiliximab-DOTA, you will need to stop breastfeeding.You have mental or emotional conditions that may prevent you from taking part in the study. The Principal Investigator will determine if this applies to you.You are expected to live for at least 6 more months.You have cancer that has come back after treatment (relapsed), or cancer that is not responding to treatment (refractory), or your cancer is stable, or you have partially or completely responded to treatment (PR or CR). You have already had at least two rounds of treatment, and a stem cell transplant is not an option for you.Your body mass index (BMI) is very high, and the decision to include you in the study will be made by the Radiation Oncology leader on a case-by-case basis.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (yttrium Y 90 basiliximab, BEAM, AHCT)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA sanctioned Yttrium Y 90 Basiliximab for patient use?
"Since this is a Phase 1 study, indicating limited safety and efficacy information, Yttrium Y 90 Basiliximab received a score of 1 for its risk assessment."
Answered by AI
Has Yttrium Y 90 Basiliximab been explored in any other scientific investigations?
"Currently, 581 clinical trials are studying the efficacy of Yttrium Y 90 Basiliximab. Of those in operation 142 have reached Phase 3 status and 22318 sites are running studies for this treatment with the majority based in Ann Arbor, Michigan."
Answered by AI
Are there any unfilled slots in this research endeavor?
"Unfortunately, clinicaltrials.gov currently indicates that this particular medical trial is not recruiting any more participants - it was initially posted on June 8th 2020 and last edited on March 17th 2022. Fortunately though, there are a large number of alternative trials (3244 in total) presently welcoming volunteers."
Answered by AI
How many participants are being accepted for this clinical experiment?
"At the present time, no further patients are being sought for this trial. Initially posted on June 8th 2020 and last modified March 17th 2022, any interested persons should refer to the 2663 studies actively seeking participants with lymphoma, t-cell peripheral issues or the 581 trials looking for those dealing with Yttrium Y 90 Basiliximab."
Answered by AI
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