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Radioimmunotherapy

Radioimmunotherapy + CAR T-cell Therapy for Acute Lymphoblastic Leukemia and Non-Hodgkin's Lymphoma

Q: Is enrollment currently open for this clinical trial?

<p>Affirmative, the clinicaltrials.gov database denotes that this trial is currently enlisting participants. First advertised on February 2nd 2021 and last updated on October 26th 2022, 6 individuals are sought from one site for inclusion in the study.</p>

Q: What is the current sample size of this research endeavor?

<p>Affirmative. Clinicaltrials.gov's documentation shows that the trial was first published on February 2nd 2021, and is still actively recruiting participants as of October 26th 2022. 6 individuals are needed to be recruited from 1 centre.</p>

Phase < 1

Recruiting

Led By Mark B Geyer, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with B-cell acute lymphoblastic leukemia or B lymphoblastic lymphoma (ALL) or chronic myeloid leukemia (CML) in lymphoid blast crisis: ("B-ALL patients")

Patients with Philadelphia chromosome-negative B-cell ALL must have been refractory to at least 1 line of multi-agent chemotherapy or relapsed following at least 1 prior multiagent systemic chemotherapy regimen that included induction and consolidation therapy.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days after treatment

Awards & highlights

Study Summary

This trial is testing a new way to give CAR T cells, using a lower dose of radiation to prepare the patient's body. They want to find the maximum tolerated dose of the new method.

Who is the study for?

Adults with relapsed or refractory B-cell acute lymphoblastic leukemia or diffuse large B-cell lymphoma, who have tried and not responded to previous treatments. They must have a certain level of organ function, no severe heart conditions, and cannot be pregnant. Those with active infections or other serious health issues are excluded.Check my eligibility

What is being tested?

The trial is testing the combination of a radioactive antibody called 131-I apamistamab followed by CAR T-cell therapy in patients with specific types of blood cancer. The goal is to find the highest dose that patients can tolerate without too many side effects.See study design

What are the potential side effects?

Potential side effects may include reactions related to radioactivity exposure from 131-I apamistamab such as nausea and thyroid issues, as well as those associated with CAR T-cell therapy like fever, difficulty breathing, confusion, and weakness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have B-cell acute lymphoblastic leukemia or chronic myeloid leukemia in blast crisis.

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My B-cell ALL did not respond to or has returned after chemotherapy.

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My B-ALL or DLBCL cancer has returned or is not responding to treatment.

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My oxygen levels are 92% or higher without extra oxygen.

Select...

My leukemia did not respond to advanced treatment.

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My cancer has spread to my bones or I have a tumor that shows up on PET scans.

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I am 18 years old or older.

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I have signs of cancer remaining before receiving CAR T-cell therapy.

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I have been diagnosed with a type of lymphoma called diffuse large B-cell.

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My kidneys are functioning well enough to filter waste.

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My cancer affects my B-cells, is CD19 positive, and has not responded to treatment.

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I can take care of myself and perform daily activities.

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My DLBCL or HGBL cancer did not respond to 2+ treatments including anthracycline and CD20 therapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days after treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days after treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days after treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Dose-limiting toxicities and maximum tolerated dose of 131-I apamistamab, when given in combination with 19-28z CAR T-cells for treatment of relapsed or refractory B-cell ALL or DLBCL

Trial Design

1Treatment groups

Experimental Treatment

Group I: B-Cell Acute Lymphoblastic Leukemia/Diffuse Large B-Cell LymExperimental Treatment2 Interventions

Participants will have relapsed or refractory B-Cell Acute Lymphoblastic Leukemia or Diffused Large B-Cell Lymphoma

0 / 13Eligibility criteria met

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,935 Previous Clinical Trials

588,849 Total Patients Enrolled

Actinium PharmaceuticalsIndustry Sponsor

6 Previous Clinical Trials

256 Total Patients Enrolled

Mark B Geyer, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

Media Library

131-I Apamistamab (Radioimmunotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT04512716 — Phase < 1

Acute Lymphoblastic Leukemia Research Study Groups: B-Cell Acute Lymphoblastic Leukemia/Diffuse Large B-Cell Lym

Acute Lymphoblastic Leukemia Clinical Trial 2023: 131-I Apamistamab Highlights & Side Effects. Trial Name: NCT04512716 — Phase < 1

131-I Apamistamab (Radioimmunotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04512716 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment currently open for this clinical trial?

"Affirmative, the clinicaltrials.gov database denotes that this trial is currently enlisting participants. First advertised on February 2nd 2021 and last updated on October 26th 2022, 6 individuals are sought from one site for inclusion in the study."

Answered by AI

What is the current sample size of this research endeavor?

"Affirmative. Clinicaltrials.gov's documentation shows that the trial was first published on February 2nd 2021, and is still actively recruiting participants as of October 26th 2022. 6 individuals are needed to be recruited from 1 centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma

2021. "Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04512716.

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