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    • David Wallace BioDavid Wallace - MPN Patient Advocate

      David Wallace

      Founder & CEO of MPN Cancer Connection and PV Reporter | Patient Advocate

      When David was diagnosed with PV in 2009, at the age of 47, he soon learned there was limited and often conflicting information available on Myeloproliferative Neoplasms (MPNs). He also realized early on in his diagnosis, the importance of advocating for himself to best manage his polycythemia vera (PV). David was grateful for the early support and guidance of fellow MPN patients on his journey and wanted a way to give back to the MPN community. With a professional background in business administration and sociology, David has a passion for finding solutions and helping others. In 2013, David used his skill set to create PV Reporter,
      a comprehensive patient-focused website for MPNs. David refers to his site as a hub for patients to begin to research their cancer. Whether a patient, caregiver or healthcare provider, PV Reporter offers visitors a wealth of educational resources, patient stories, articles, and the latest news on the treatment for MPNs, helping MPN patients and their caregivers stay informed, connected and empowered. In 2015, along with the help of others, David founded a non-profit MPN Cancer Connection (MPN-CC), a patient-led 501©3 formed to create awareness that MPN patients are “cancer patients” and should have complete access to local and national programs and benefits. David’s philosophy is to educate patients to become their own advocates so that they can make informed decisions on their treatment. David’s dedication to the MPN community is further evidenced through his work and awards:
      • Selected to endorse 2018 NCCN guidelines for MPN patients by MPN Cancer Connection
      • Selected to represent the United States as a patient advocate by MPNs Advocate Network International Conference 2016-2019
      • Recipient of MPN Hero Award 2016
      • Published in MD Anderson Cancer Center MPN Focus Newsletter Fall 2016
      • Appearance on “The Doctors” TV show in 2015 to promote MPN awareness
      • Awarded Press Credentials for American Society of Hematology Conference 2014-2019
      • Contributor to Patient Power MPN educational videos
      David lives in Charlotte, North Carolina. When he’s not working, David enjoys spending time with family, listening to live music, attending outdoor festivals, watching the Carolina Panthers, riding his motorcycle, traveling and of course having his beloved Aussiedoodle Bailey by his side.
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Clinical Trial Finder

Clinical Trial Finder

Search Results

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

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 65 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

The following criteria are used to enroll patients in the study before transplant.
  • - 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.
The following criteria are required within 48 hours prior to infusion of the EAGD T cell product.
  • - 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.

Exclusion Criteria:

  • - 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03533816
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University of Kansas Medical Center
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Joseph McGuirk, M.D.
Principal Investigator Affiliation University of Kansas Medical Center
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Acute Myeloid Leukemia, Chronic Myeloid Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndromes
Additional Details

Many patients with hematological malignancies require a bone marrow transplant for curative treatment. A matched sibling donor is optimal but may not be available. Therefore, a partially matched family member (haploidentical) may be a viable alternative. The incidence of graft vs.#46; host disease, however, can become more of a significant, even fatal, factor with partial matches. T-cells have been shown to be the key player in the post-transplant immune phenomena. The majority of T-cells are composed of alpha beta T-cells with a small minority of gamma delta T-cells, which are known to have the unique ability to kill malignant cells without antigen recognition. This study proposes to extract, concentrate, and activate gamma delta T-cells from the peripheral blood to provide innate anti-tumor effect with minimal risk of GVHD. Safety and impact and/or the rate of GVHD will be evaluated.

Arms & Interventions

Arms

Experimental: EAGD T-cell infusion (Phase I)

Peripheral blood is collected by leukapheresis from the donor, expanded and activated on CliniMACS-Prodigy, further depleted of alpha beta T-cells using the CliniMACS Alpha Beta T-Cell Depletion System, which leaves a gamma delta T-cell rich product. This product is then infused into the recipient at either 1, 3, or 10 x 1,000,000 cells/kg concentrations depending upon the cohort.

Experimental: EAGD T-cell infusion (Expansion)

Peripheral blood is collected by leukapheresis from the donor, expanded and activated on CliniMACS-Prodigy, further depleted of alpha beta T-cells using the CliniMACS Alpha Beta T-Cell Depletion System, which leaves a gamma delta T-cell rich product. This product is then infused into the recipient at the maximum tolerated dose as determined from Phase I.

Interventions

Drug: - EAGD T-cell infusion (Phase I)

The Alpha Beta (α/β) T-Cell Depletion System utilizes the CliniMACS instrument to yield a gamma delta (γδ) enriched cell therapy product.

Drug: - EAGD T-cell infusion (Expansion)

The Alpha Beta (α/β) T-Cell Depletion System utilizes the CliniMACS instrument to yield a gamma delta (γδ) enriched cell therapy product.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Kansas Cancer Center, Westwood, Kansas

Status

Recruiting

Address

University of Kansas Cancer Center

Westwood, Kansas, 66205

Site Contact

Clinical Trials Nurse Navigator

ctnursenav@kumc.edu

913-945-7552

Nearest Location

Site Contact

Clinical Trials Nurse Navigator

ctnursenav@kumc.edu

913-945-7552

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The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.

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