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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

Must not have

- Patients with blastic transformation of chronic myelogenous leukemia are ineligible

- Pregnant women are excluded from this study because there is an unknown but potential risk for adverse events in the fetus. Breastfeeding should be discontinued if the mother is treated. These potential risks may also apply to other agents used in this study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have a blastic phase of chronic myeloid leukemia.

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I am not pregnant or breastfeeding.

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I have been diagnosed with acute promyelocytic leukemia.

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I am mostly bedridden or completely bedbound due to my health.

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I do not have any uncontrolled illnesses that could interfere with the study.

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I have had a bone marrow transplant from a donor.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Hematologic Response

Overall Response Rate

Overall Survival

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 15Eligibility criteria met