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TCR α/β-Depleted DLI for Leukemia

Phase 1

Waitlist Available

Led By Guenther Koehne, MD, PhD

Research Sponsored by Baptist Health South Florida

Eligibility Criteria Checklist

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

Must have

Patients with hematologic malignancies that are candidates CD34+ selected, T-cell depleted allogeneic hematopoietic stem cell transplantation

Patients must have a Karnofsky (adult) Performance Status of at least 70%

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial is being conducted to study the safety and efficacy of an investigational cellular product in patients with lymphoid or myeloid malignancies who have undergone T-cell depleted allogeneic hematopoietic cell transplantation.

Who is the study for?

This trial is for adults aged 18-75 with certain blood cancers who've had a T-cell depleted stem cell transplant. They need to be fairly active (70% on Karnofsky scale), have good heart, liver, kidney, and lung function, and agree to participate in research.Check my eligibility

What is being tested?

The study tests if immune cells from donors, treated to remove ones causing graft vs host disease, can safely improve cancer outcomes post-transplant. It looks at the effect on residual disease, infection rates, and survival without cancer progression.See study design

What are the potential side effects?

Potential side effects may include reactions related to the immune system such as fever or fatigue due to infusion of donor cells. There's also a risk of complications from graft versus host disease despite the depletion of specific T-cells.

Eligibility Criteria

Inclusion Criteria

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

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I am eligible for a specific stem cell transplant for my blood cancer.

Select...

I am mostly able to care for myself but cannot do any heavy physical work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Incidence of treatment-emergent serious adverse events (TE-SAEs)

Secondary outcome measures

Disease free survival- measured by absence of relapse/recurrence or death.

Number of participants in remission

Number of participants with transplant-associated viral complications

+1 more

Trial Design

6Treatment groups

Experimental Treatment

Group I: HLA Mismatched Cohort IIIExperimental Treatment1 Intervention

1 x 10^5/kg starting time point Y (whichever was safest as determined by Mismatched Cohort I), 5 x 10^5/kg 3-4 weeks after first dose, and 1 x 10^6/kg 3-4 weeks after second dose

Group II: HLA Mismatched Cohort IIExperimental Treatment1 Intervention

1 x 10^5/kg starting time point Y (whichever was safest as determined by Mismatched Cohort I), 5 x 10^5/kg 3-4 weeks after first dose, and 5 x 10^5/kg 3-4 weeks after second dose

Group III: HLA Mismatched Cohort IExperimental Treatment1 Intervention

1 x 10^5/kg at 6-7 weeks post-transplant (Group A), 4-5 weeks post-transplant (Group B), or 2-3 weeks post-transplant (Group C)

Group IV: HLA Matched Cohort IIIExperimental Treatment1 Intervention

5 x 10^5/kg starting time point X (whichever was safest as determined by Matched Cohort I), 1 x 10^6/kg 3-4 weeks after first dose, and 2 x 10^6/kg 3-4 weeks after second dose

Group V: HLA Matched Cohort IIExperimental Treatment1 Intervention

5 x 10^5/kg starting time point X (whichever was safest as determined by Matched Cohort I), 1 x 10^6/kg 3-4 weeks after first dose, and 1 x 10^6/kg 3-4 weeks after second dose

Group VI: HLA Matched Cohort IExperimental Treatment1 Intervention

5 x 10^5/kg at 6-7 weeks post-transplant (Group A), 4-5 weeks post-transplant (Group B), or 2-3 weeks post-transplant (Group C)

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Baptist Health South FloridaLead Sponsor

48 Previous Clinical Trials

7,820 Total Patients Enrolled

Guenther Koehne, MD, PhDPrincipal InvestigatorMiami Cancer Institute

3 Previous Clinical Trials

122 Total Patients Enrolled

Media Library

T-cell Receptor α/β Depleted Donor Lymphocyte Infusions Clinical Trial Eligibility Overview. Trial Name: NCT05350163 — Phase 1

Acute Lymphoblastic Leukemia Research Study Groups: HLA Matched Cohort I, HLA Matched Cohort II, HLA Matched Cohort III, HLA Mismatched Cohort I, HLA Mismatched Cohort II, HLA Mismatched Cohort III

Acute Lymphoblastic Leukemia Clinical Trial 2023: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions Highlights & Side Effects. Trial Name: NCT05350163 — Phase 1

T-cell Receptor α/β Depleted Donor Lymphocyte Infusions 2023 Treatment Timeline for Medical Study. Trial Name: NCT05350163 — Phase 1

Frequently Asked Questions

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

Are any new participants being enrolled in this investigation at the moment?

"As per data found on clinicaltrials.gov, enrollment for this medical trial is currently ongoing since it was first posted on April 5th 2022 and last updated May 24th 2022."

Answered by AI

Could I be considered a suitable candidate for this trial?

"This clinical trial requires 24 participants with plasma cells in the age range of 18-74. Primarily, these individuals must meet several criteria such as a minimum Karnofsky Performance Status of 70%, an LVEF at rest no lower than 50%, serum creatinine below 1.2 mg/dl or CrCl above 40ml/m if outside normal ranges, and DLCO levels at least 50% of predicted (correcting for hemoglobin). Furthermore, all participants are required to provide informed consent prior to entering the study."

Answered by AI

Are younger individuals eligible to participate in the experiment?

"This research is seeking volunteers aged 18 and over, but no older than 74."

Answered by AI

What is the aggregate headcount of contributors to this research?

"Affirmative. Clinicaltrials.gov attests that this clinical trial, first published on April 5th 2022, is currently recruiting patients. 24 individuals need to be admitted from one medical centre in total."

Answered by AI

Has the FDA authorized T-cell Receptor α/β Depleted Donor Lymphocyte Infusions?

"As this is an early-stage Phase 1 trial, our team at Power have assigned T-Cell Receptor α/β Depleted Donor Lymphocyte Infusions a score of 1 in terms of safety due to limited data that has been collected on its efficacy."

Answered by AI

Recent research and studies

New England Journal of MedicineJournal

Cyclosporine, Methotrexate, and Prednisone Compared with Cyclosporine and Prednisone for Prophylaxis of Acute Graft-versus-host Disease

Chao, Nelson J., Gerhard M. Schmidt, Joyce C. Niland, Michael D. Amylon, Andrew C. Dagis, Gwynn D. Long, Auayporn P. Nademanee, et al.. 1993. “Cyclosporine, Methotrexate, and Prednisone Compared with Cyclosporine and Prednisone for Prophylaxis of Acute Graft-versus-host Disease”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejm199310213291703.

BloodJournal

Wt1-specific T-cell Responses in High-risk Multiple Myeloma Patients Undergoing Allogeneic T Cell–depleted Hematopoietic Stem Cell Transplantation and Donor Lymphocyte Infusions

Tyler, Eleanor M., Achim A. Jungbluth, Richard J. O'Reilly, and Guenther Koehne. 2013. “Wt1-specific T-cell Responses in High-risk Multiple Myeloma Patients Undergoing Allogeneic T Cell–depleted Hematopoietic Stem Cell Transplantation and Donor Lymphocyte Infusions”. Blood. American Society of Hematology. doi:10.1182/blood-2012-06-435040.

The Lancet HaematologyJournal

Addition of Anti-thymocyte Globulin to Standard Graft-versus-host Disease Prophylaxis Versus Standard Treatment Alone in Patients with Haematological Malignancies Undergoing Transplantation from Unrelated Donors: Final Analysis of a Randomised, Open-label, Multicentre, Phase 3 Trial

Walker, Irwin, Tony Panzarella, Stephen Couban, Felix Couture, Gerald Devins, Mohamed Elemary, Geneviève Gallagher, et al.. 2020. “Addition of Anti-thymocyte Globulin to Standard Graft-versus-host Disease Prophylaxis Versus Standard Treatment Alone in Patients with Haematological Malignancies Undergoing Transplantation from Unrelated Donors: Final Analysis of a Randomised, Open-label, Multicentre, Phase 3 Trial”. The Lancet Haematology. Elsevier BV. doi:10.1016/s2352-3026(19)30220-0.

BloodJournal