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Chemotherapy

Treg-Enriched Stem Cell Transplant for Leukemia

Phase 1

Recruiting

Led By John Koreth, MBBS, DPhil

Research Sponsored by Dana-Farber Cancer Institute

Eligibility Criteria Checklist

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

Must have

Cohort A: Histologically-confirmed disease in the prior 4 weeks, despite at least 1 prior line of therapy (e.g., 3+7 chemotherapy, HMA therapy): Rel/ref AML (de novo or secondary) with ≥5% blasts in BM (or extramedullary sites); MDS EB-2 (BM ≥10% blasts, PB 5-19% blasts). Cohort B: Ultra high-risk AML or MDS that meets definition of 'Myeloid Neoplasms with mutated TP53' per 2022 International Consensus Classification1 (Appendix L) regardless of response

Available haploidentical HLA-matched (-A, -B, -C, -DRB1) related donor aged 18-65 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days after hematopoietic cell transplantation (hct)

Awards & highlights

Study Summary

This trial is studying a new way to give a haploidentical stem cell transplant (using donor cells that have been enriched with regulatory T cells) to people with relapsed or refractory acute myeloid leukemia or myelodysplastic syndrome.

Who is the study for?

Adults aged 18-65 with relapsed/refractory acute myeloid leukemia (AML) or high-risk myelodysplastic syndromes (MDS), who have a compatible family donor, can join this trial. Participants need good heart, lung, and kidney function and must not be pregnant or breastfeeding. They should agree to use contraception during the study.Check my eligibility

What is being tested?

The trial is testing an experimental stem cell transplant method using radiation, chemotherapy (Fludarabine, Thiotepa, Cyclophosphamide plus Mesna), and infusions of Treg-enriched donor cells along with unmodified haplo donor T cells and CD34+ Peripheral Blood Stem Cells in patients with AML/MDS.See study design

What are the potential side effects?

Potential side effects include reactions to the infusion of cells, organ damage from radiation or chemotherapy drugs like Fludarabine and Cyclophosphamide. There's also a risk of infection due to immune system suppression by treatments.

Eligibility Criteria

Inclusion Criteria

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

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I have a related donor aged 18-65 who is a partial HLA match.

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I am between 18 and 65 years old.

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My kidney function is within the normal range.

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I can take care of myself but might not be able to do active work.

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My heart pumps well and I don't have high blood pressure in my lungs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days after hematopoietic cell transplantation (hct)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days after hematopoietic cell transplantation (hct)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days after hematopoietic cell transplantation (hct) 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 (DLT)

Secondary outcome measures

Engraftment rate

Mortality Rate-GVHD Non- Relapse

Graft-vs-Host Disease

+6 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: IS-FREE TREG CRAFT_ENGINEERED HaploHCT for relapsed/refractory AML or MDS EB-2Experimental Treatment8 Interventions

After meeting eligibility criteria and being enrolled, patients will receive: Day -15 to -6 prior to hematopoietic stem cell transplant (HSCT), preparatory regimen of radiation and chemotherapy: Total Myeloid and Lymphoid Irradiation (TMLI): Days -15 to -11 prior to HSCT; - Chemotherapy (infusion): Day -10 to day -6 prior to HSCT: Fludarabine (all days), Thiotepa (days -10 and -9) and Cyclophosphamide and Mesna (days -8 and -7) Day -4 prior to (HSCT), a Treg-enriched donor cell infusion and graft vs host disease (GVHD) assessment Day -1 prior to (HSCT), a unmodified donor T Cell infusion and (GVHD) assessment Day of (day 0) (HSCT), CD34+ Haplo Peripheral Blood Stem Cell Infusion/Transplant and (GVHD) assessment Days 30, 60,100, 180, 365 post hematopoietic stem cell transplant (HSCT), participants will undergo testing and assessment of minimal residual disease (MRD) and (GVHD)

Group II: IS-FREE TREG CRAFT_ENGINEERED HaploHCT for Ultra high-risk AML or MDS with mutated TP53Experimental Treatment8 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Mesna

2003

Completed Phase 2

~1380

Cyclophosphamide

1995

Completed Phase 3

~3770

Radiation

2003

Completed Phase 3

~1020

Fludarabine

2012

Completed Phase 3

~1100

Thiotepa

2008

Completed Phase 3

~2150

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor

1,079 Previous Clinical Trials

340,966 Total Patients Enrolled

John Koreth, MBBS, DPhilPrincipal Investigator - Dana-Farber Cancer Institute

Dana-Farber Cancer Institute

Maulana Azad Medical College (Medical School)

Brigham & Women'S Hospital (Residency)

5 Previous Clinical Trials

141 Total Patients Enrolled

Media Library

$Myeloid Leukemia Research Study Groups: IS-FREE TREG CRAFT_ENGINEERED HaploHCT for relapsed/refractory AML or MDS EB-2, IS-FREE TREG CRAFT_ENGINEERED HaploHCT for Ultra high-risk AML or MDS with mutated TP53$

Cyclophosphamide (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04678401 — Phase 1

Frequently Asked Questions

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

Could you elaborate on prior research involving Treg-enriched donor cells?

"Currently, there are 161 Phase 3 trials and a total of 900 active trials for Treg-enriched donor cell. These medical studies span across 28,633 different locations with the majority being located in Philadelphia, Pennsylvania."

Answered by AI

For what purposes is Treg-enriched donor cell typically utilized?

"Treg-enriched donor cell is a common intervention for multiple sclerosis, but it can also be effectively used to manage leukemia, myelocytic, acute and retinoblastoma cases as well as histiocytic lymphoma."

Answered by AI

Can I be considered as a potential participant in this research project?

"This medical trial is actively seeking 10 patients who have been diagnosed with Myelodysplastic Syndromes and are of legal age. Additionally, the patient must possess an Eastern Cooperative Oncology Group Performance Status score no higher than 2 (KarnofskyScore ≥60) and be ineligible for myeloablative HCT due to their advanced years; minors cannot participate in this study at present, though they may qualify for future paediatric trials."

Answered by AI

Do any positions remain available in this research program?

"Affirmative. According to information accessible on clinicaltrials.gov, this experiment is presently recruiting participants. It was initially published on December 1st 2021 and its most recent update occurred June 24th 2022. Recruitment campaigns are currently targeting 10 potential patients from a single site."

Answered by AI

How many participants are eligible for this investigation?

"Affirmative. The information hosted on clinicaltrials.gov verifies that this study is actively recruiting patients, which was first posted on December 1st 2021 and last amended June 24th 2022. Ten participants need to be recruited from a single medical centre."

Answered by AI

Is the Food and Drug Administration sanctioning Treg-enriched donor cell treatments?

"The safety of Treg-enriched donor cells is rated as a 1 on our team's scale due to the preliminary nature of this Phase 1 trial, which has yet to yield comprehensive results for either efficacy or safety."

Answered by AI

Is this clinical trial open to people over a certain age threshold?

"To be eligible for this clinical trial, individuals must between 18 and 65 years old. In contrast, there are 989 studies aiming to recruit participants under the age of 18 and 2982 targeting those over 65."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

IS-free Treg HaploHCT

John Koreth, MD 2021. "IS-free Treg HaploHCT". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04678401.

All > Graft Vs Host Disease > Myelodysplastic Syndrome