RECRUITING

Expanded/Activated Gamma Delta T-cell Infusion Following Hematopoietic Stem Cell Transplantation and Post-transplant Cyclophosphamide

Conditions

Acute Myeloid Leukemia Chronic Myeloid Leukemia Acute Lymphoblastic Leukemia Myelodysplastic Syndromes Gamma delta T-cells Hematopoietic Stem Cell Transplantation (HCT)Post-transplant Cyclophosphamide (PTCy)Expanded/Activated gamma delta (EAGD)Graft versus host disease (GVHD)haploidentical

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Gamma delta T-cells are part of the innate immune system with the ability to recognize malignant cells and kill them. This study uses gamma delta T-cells to maximize the anti-tumor response and minimize graft versus host disease (GVHD) in leukemic and myelodysplastic patients who have had a partially mismatched bone marrow transplant (haploidentical).

Official Title

Phase I Study of Ex Vivo Expanded/Activated Gamma Delta T-cell Infusion Following Haploidentical Hematopoietic Stem Cell Transplantation and Post-transplant Cyclophosphamide

Quick Facts

Study Start:2020-01-31

Study Completion:2025-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03533816

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Patients with neoplastic hematological disorders with indication of allogeneic transplant according to the National Comprehensive Cancer Network (NCCN) or other standard guidelines as follows: * Acute myeloid leukemia \[AML\] in morphologic complete remission with intermediate/high-risk features (per NCCN criteria) or relapsed disease * Chronic myeloid leukemia \[CML\] in any chronic phase. * Myelodysplastic syndrome \[MDS\] with intermediate/high risk features or refractory disease (with bone marrow blast count \<10%). * Acute lymphoblastic leukemia \[ALL\] in morphologic complete remission with high-risk features or relapsed disease. * Negative test for donor-specific antibody within 28 days of starting conditioning regimen. * Age Criteria: 19-65 years. * Organ Function Criteria: The following organ function testing should be done within 35 days before study registration. * Cardiac: Normal left ventricular ejection fraction (LVEF) (50% or above) as measured by MUGA or Echocardiogram. * Pulmonary: FVC, FEV1 and DLCO (corrected) should be 50% or above of expected. * Renal: serum creatinine level to be \<2 mg/dl AND estimated (Cockcroft-Gault formula) or measured (takes priority if done) creatinine clearance (CrCl) must be equal or greater than 70 mL/min/1.73 m2. * Hepatic: serum bilirubin 1.5 upper limit of normal (ULN), Aspartate transaminase (AST)/alanine transaminase (ALT) 2.5 ULN, and alkaline phosphatase 2.5 ULN. * Performance status: Karnofsky performance score (KPS) or Lansky score: ≥80. * Hematopoietic cell transplant comorbidity index (HCT-CI) \<3. Exception may be made on individual cases after discussion with the primary investigator. * Consent: All patients must be informed of the investigational nature of this study and given written informed consent in accordance with institutional and federal guidelines. * Absence of uncontrolled infection with sepsis syndrome (e.g persistent positive blood culture). * NO hemodynamic instability (due to sepsis or organ dysfunction) or circulatory volume overload. * NO clinically significant organ toxicity that are defined as follows: * Heart failure with subnormal LVEF or clinical fluid overload. * Elevated serum creatinine or subnormal creatinine clearance (either estimated or measured). * Elevated total bilirubin ≥1.5 upper normal level (unless indirect hyperbilirubinemia attributed to non-hepatic pathology), or elevated liver enzymes (ALT, AST, ALP) \>5 x ULN. * Hypoxemia requiring oxygen therapy * NO acute graft versus host disease (any grade). * Neutrophil engraftment.	* Non-compliant patients. * No appropriate caregivers identified. * Uncontrolled medical or psychiatric disorders which may preclude patients to undergo clinical studies (Discretion of the attending physician). * Active central nervous system (CNS) neoplastic involvement. * Morbid obesity with body mass index \>35 (borderline cases may be considered on case-by-case basis after discussion with the primary investigator). * Patients with known allergy to DMSO. * HIV1 (Human Immunodeficiency Virus-1) or HIV2 positive. * Pregnant or breastfeeding women.

Inclusion Criteria

Exclusion Criteria

* Patients with neoplastic hematological disorders with indication of allogeneic transplant according to the National Comprehensive Cancer Network (NCCN) or other standard guidelines as follows:
* Acute myeloid leukemia \[AML\] in morphologic complete remission with intermediate/high-risk features (per NCCN criteria) or relapsed disease
* Chronic myeloid leukemia \[CML\] in any chronic phase.
* Myelodysplastic syndrome \[MDS\] with intermediate/high risk features or refractory disease (with bone marrow blast count \<10%).
* Acute lymphoblastic leukemia \[ALL\] in morphologic complete remission with high-risk features or relapsed disease.
* Negative test for donor-specific antibody within 28 days of starting conditioning regimen.
* Age Criteria: 19-65 years.
* Organ Function Criteria: The following organ function testing should be done within 35 days before study registration.
* Cardiac: Normal left ventricular ejection fraction (LVEF) (50% or above) as measured by MUGA or Echocardiogram.
* Pulmonary: FVC, FEV1 and DLCO (corrected) should be 50% or above of expected.
* Renal: serum creatinine level to be \<2 mg/dl AND estimated (Cockcroft-Gault formula) or measured (takes priority if done) creatinine clearance (CrCl) must be equal or greater than 70 mL/min/1.73 m2.
* Hepatic: serum bilirubin 1.5 upper limit of normal (ULN), Aspartate transaminase (AST)/alanine transaminase (ALT) 2.5 ULN, and alkaline phosphatase 2.5 ULN.
* Performance status: Karnofsky performance score (KPS) or Lansky score: ≥80.
* Hematopoietic cell transplant comorbidity index (HCT-CI) \<3. Exception may be made on individual cases after discussion with the primary investigator.
* Consent: All patients must be informed of the investigational nature of this study and given written informed consent in accordance with institutional and federal guidelines.
* Absence of uncontrolled infection with sepsis syndrome (e.g persistent positive blood culture).
* NO hemodynamic instability (due to sepsis or organ dysfunction) or circulatory volume overload.
* NO clinically significant organ toxicity that are defined as follows:
* Heart failure with subnormal LVEF or clinical fluid overload.
* Elevated serum creatinine or subnormal creatinine clearance (either estimated or measured).
* Elevated total bilirubin ≥1.5 upper normal level (unless indirect hyperbilirubinemia attributed to non-hepatic pathology), or elevated liver enzymes (ALT, AST, ALP) \>5 x ULN.
* Hypoxemia requiring oxygen therapy
* NO acute graft versus host disease (any grade).
* Neutrophil engraftment.

* Non-compliant patients.
* No appropriate caregivers identified.
* Uncontrolled medical or psychiatric disorders which may preclude patients to undergo clinical studies (Discretion of the attending physician).
* Active central nervous system (CNS) neoplastic involvement.
* Morbid obesity with body mass index \>35 (borderline cases may be considered on case-by-case basis after discussion with the primary investigator).
* Patients with known allergy to DMSO.
* HIV1 (Human Immunodeficiency Virus-1) or HIV2 positive.
* Pregnant or breastfeeding women.

Contacts and Locations

Study Contact

Clinical Trial Nurse Navigator

CONTACT

913-945-7552

ctnursenav@kumc.edu

Principal Investigator

Joseph McGuirk, M.D.

PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Study Locations (Sites)

University of Kansas Cancer Center

Westwood, Kansas, 66205

United States

Collaborators and Investigators

Sponsor: University of Kansas Medical Center

Joseph McGuirk, M.D., PRINCIPAL_INVESTIGATOR, University of Kansas Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-01-31

Study Completion Date2025-01

Study Record Updates

Study Start Date2020-01-31

Study Completion Date2025-01

Terms related to this study

Keywords Provided by Researchers

Gamma delta T-cells
Hematopoietic Stem Cell Transplantation (HCT)
Post-transplant Cyclophosphamide (PTCy)
Expanded/Activated gamma delta (EAGD)
Graft versus host disease (GVHD)
haploidentical

Additional Relevant MeSH Terms

Acute Myeloid Leukemia
Chronic Myeloid Leukemia
Acute Lymphoblastic Leukemia
Myelodysplastic Syndromes