Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05350163
Other study ID # 2019-KOE-004
Secondary ID
Status Active, not recruiting
Phase Phase 1
First received
Last updated
Start date April 5, 2022
Est. completion date April 1, 2028

Study information

Verified date October 2023
Source Baptist Health South Florida
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This pilot study is being conducted to treat patients who have a certain type of malignancy (lymphoid or myeloid) with immune effector cells after a T-cell depleted allogeneic hematopoietic cell transplantation (TCD HSCT). This study is designed to see whether an investigational cellular product of immune cells obtained from a donor's cells that have been treated so that the type of cells that can lead to graft vs host disease have been removed can be safely administered. These cell products are administered following the initial stem cell transplant to assess the effect and improvement on minimal residual disease status, infectious complication, progression-free and overall survival.


Read more »

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
T-cell Receptor a/ß Depleted Donor Lymphocyte Infusions
T-cell Receptor a/ß Depleted Donor Lymphocyte Infusions following CD34+-selected Allogeneic Stem Cell Transplantation from Related and Unrelated Donors for Patients

Locations

Country Name City State
United States Miami Cancer Institute at Baptist Health, Inc Miami Florida

Sponsors (1)

Lead Sponsor Collaborator
Baptist Health South Florida

Country where clinical trial is conducted

United States, 

References & Publications (32)

See more »

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of treatment-emergent serious adverse events (TE-SAEs) TE-SAEs are defined as the composite of death, non-fatal pulmonary embolism, stroke, acute graft versus host disease (GvHD), and clinically significant laboratory test abnormalities. 30 days post-infusion
Secondary Number of participants in remission Remission - measured by absence of signs and symptoms 2 years
Secondary Number of participants with transplant-associated viral complications Transplant-associated viral complications - measured by viral infections associated with transplant 2 years
Secondary Disease free survival- measured by absence of relapse/recurrence or death. Disease free survival - measured by (absence of ) relapse/recurrence or death.
Relapse and recurrence, both will be measured by greater than 5% circulating leukemic blasts in the marrow or peripheral blood and/or the presence of blasts in any extra medullary site and/or disease determined by clinical assessment.
2 years
Secondary Overall survival - measured by death Overall survival - measured by death 2 years
See also
  Status Clinical Trial Phase
Recruiting NCT04501120 - Study of APG2575 Single Agent and Combination With Therapy in Patients Relapsed/Refractory AML Phase 1/Phase 2
Not yet recruiting NCT06090513 - Molecular Services and EMR-Lab Integration Application (ELIA) for Reducing Healthcare Disparities in Cancer Patients
Not yet recruiting NCT06129734 - Decitabine and Venetoclax Treatment as Maintenance Therapy in Patients Post Allograft Stem Cell Transplant Phase 1/Phase 2
Recruiting NCT05579769 - A Phase II Pediatric Study of a Graft-VS.-Host Disease (GVHD) Prophylaxis Regimen With no Calcineurin Inhibitors After Day +60 Post First Allogeneic Hematopoietic Cell Transplant for Hematological Malignancies Phase 2
Recruiting NCT05583175 - Venetoclax Plus RIC Regimen Allo-HSCT for Elderly Patients With High-risk Myeloid Malignancies Phase 2
Recruiting NCT06378437 - A Study of GLB-001 in Patients With Myeloid Malignancies Phase 1
Terminated NCT01596699 - Pilot Trial of Clofarabine Added to Standard Busulfan and Fludarabine for Conditioning Prior to Allogeneic Hematopoietic Cell Transplantation Phase 2
Recruiting NCT04906031 - Sodium Stibogluconate in the MDS/AML With One of the 65 Defined p53 Mutations Phase 2
Recruiting NCT05455294 - Combination Navitoclax, Venetoclax and Decitabine for Advanced Myeloid Neoplasms Phase 1
Recruiting NCT03850418 - Azacitidine and Chimerism in MDS or AML Patients After Allogeneic Stem Cell Transplant Phase 2
Recruiting NCT02958462 - Pre-myeloid Cancer and Bone Marrow Failure Clinic Study N/A
Recruiting NCT03855371 - Mutant p53-based Personalized Trial Using Decitabine and Arsenic Trioxide on AML/MDS Phase 1
Recruiting NCT05841771 - Hypomethylating Agent and Venetoclax After Allo-HSCT in Patients With High-risk Myeloid Malignancies. Phase 2
Recruiting NCT06434662 - Mitoxantrone Hydrochloride Liposome Injection, Cytarabine Combined With Venetoclax in the Treatment of R/R AML Phase 2
Completed NCT04214860 - APR-246 in Combination With Venetoclax and Azacitidine in TP53-Mutant Myeloid Malignancies Phase 1
Not yet recruiting NCT05875805 - A Telehealth Advance Care Planning Intervention N/A

External Links