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CAR T-cell Therapy

Donor Lymphocyte Infusion for MDS and AML

Phase 1 & 2

Waitlist Available

Led By Hany Elmariah, MD, MS

Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute

Eligibility Criteria Checklist

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

Must have

- Pathologically confirmed AML according to World Health Organization (WHO) criteria

- Creatinine clearance (CrCl)>50ml/min

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months

Awards & highlights

Study Summary

This trial is testing the safety of an investigational treatment for myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) after initial therapy has failed. The FDA is funding this study.

Who is the study for?

This trial is for adults aged 18-79 with Myelodysplastic Syndrome (MDS) or secondary Acute Myeloid Leukemia (sAML) who have not responded to initial therapy. Participants must be in relatively good health, with a decent performance status and adequate organ function. Pregnant women, those with certain leukemia types, recent chemotherapy or radiotherapy recipients, and individuals with severe concurrent illnesses are excluded.Check my eligibility

What is being tested?

The study tests the safety of CD8 Depleted donor lymphocytes from mismatched unrelated donors combined with standard chemotherapy in patients whose MDS has progressed after first-line treatment or turned into sAML. The goal is to see if this investigational approach can help control the disease.See study design

What are the potential side effects?

Potential side effects may include reactions related to immune cells infusion such as fever and chills, risk of infections due to lowered immunity from chemotherapy, organ-specific inflammation due to immune response alterations, fatigue from treatment burden on the body's resources, and typical chemotherapy-related issues like nausea.

Eligibility Criteria

Inclusion Criteria

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

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My diagnosis of AML is confirmed by lab tests.

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My kidneys are functioning well.

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My previous treatment with an HMA was unsuccessful or caused intolerable side effects.

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My condition is confirmed as MDS or MDS/MPN.

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I am between 60 and 79 years old.

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My MDS did not improve after HMA therapy.

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I am between 18 and 79 years old.

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I am considered fit for chemotherapy.

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I am able to get out of my bed or chair and move around.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Maximum Tolerated Dose of CD8 depleted non-engrafting HLA-mismatched unrelated donor lymphocytes infusion (NE-DLI)

Secondary outcome measures

Hematologic Response

Overall Response Rate

Overall Survival

+1 more

Trial Design

4Treatment groups

Experimental Treatment

Group I: Phase 2 -Treatment at Maximum Tolerated Dose (MTD)Experimental Treatment2 Interventions

All participants will receive cytotoxic induction chemotherapy with a standard of care cytarabine-based regimen. 24-36 hours after chemotherapy cessation, participants will receive CD8-depleted non-engrafting HLA-mismatched unrelated donor lymphocyte infusion (NE-DLI) at MTD.

Group II: Phase 1 Dose Level 3Experimental Treatment2 Interventions

Group III: Phase 1 Dose Level 2Experimental Treatment2 Interventions

Group IV: Phase 1 Dose Level 1Experimental Treatment2 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Standard of Care Chemotherapy

2014

Completed Phase 2

~270

0 / 9Eligibility criteria met

Find a Location

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor

542 Previous Clinical Trials

135,473 Total Patients Enrolled

Hany Elmariah, MD, MSPrincipal InvestigatorMoffitt Cancer Center

2 Previous Clinical Trials

83 Total Patients Enrolled

Media Library

CD8 Depleted, Non-engrafting,HLA mismatched unrelated donor lymphocytes (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04620681 — Phase 1 & 2

Myelodysplastic Syndrome Research Study Groups: Phase 1 Dose Level 1, Phase 1 Dose Level 2, Phase 1 Dose Level 3, Phase 2 -Treatment at Maximum Tolerated Dose (MTD)

Myelodysplastic Syndrome Clinical Trial 2023: CD8 Depleted, Non-engrafting,HLA mismatched unrelated donor lymphocytes Highlights & Side Effects. Trial Name: NCT04620681 — Phase 1 & 2

CD8 Depleted, Non-engrafting,HLA mismatched unrelated donor lymphocytes (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04620681 — Phase 1 & 2

Frequently Asked Questions

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

Does the age restriction for this investigation preclude those aged thirty and above?

"This trial is in search of participants who are above the age of majority and have not yet reached their eightieth birthday."

Answered by AI

Are there any remaining vacancies in this clinical experiment?

"Information on clinicaltrials.gov suggests that this medical trial is still open to applicants. It was first put up for recruitment on January 14th 2021 and the latest update occurred on September 27th 2022."

Answered by AI

What is the maximum number of participants for this medical trial?

"Affirmative. The information on clinicaltrials.gov states that this exam is seeking participants at the present time, with it being initially posted on January 14th 2021 and most recently updated September 27th 2022. This medical examination requires 28 individuals to be recruited from 1 venue."

Answered by AI

May I submit my candidacy for this research project?

"To be considered for participation, those who suffer from myelodysplastic syndromes must fall between the ages of 18 and 79. A total of 28 patients are being enrolled in this clinical trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

CD8 Depleted, Non-engrafting, HLA Mismatched Unrelated Infusion With MDS and Secondary AML

2021. "CD8 Depleted, Non-engrafting, HLA Mismatched Unrelated Infusion With MDS and Secondary AML". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04620681.

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