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MPN Clinical Trial Finder

Clinical Trial Finder

Search Results

MCW Alpha/Beta T-Cell and B-Cell Depletion With Targeted ATG Dosing

Study Purpose

This is a single arm pilot study for patients with hematologic malignancies receiving unrelated or haploidentical related mobilized peripheral stem cells (PSCs) using the CliniMACS system for alpha/beta T cell depletion plus CD19+ B cell depletion with individualized ALC-based dosing of ATG to study impact on engraftment, GVHD, and disease free survival

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 0 Years - 25 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Patient age < 25 years. Both genders and all races eligible. 2. Disease eligibility.
  • - Acute myeloid leukemia, primary or secondary - Disease status: MRD negative (flow MRD ≤ 0.1%) - Myelodysplasia.
  • - Acute lymphoblastic leukemia - Disease status: MRD negative.
  • - Chronic myelogenous leukemia - Disease status: chronic phase, accelerated phase or blast crisis now in second chronic phase.
  • - Mixed lineage or biphenotypic acute leukemia- Disease status: MRD negative.
  • - Lymphoblastic lymphoma - Disease status: in remission.
  • - Burkitt's lymphoma/leukemia - Disease status: in remission.
  • - Lymphoma after relapse - Disease status: in remission.
  • - Other malignant hematologic diseases in remission (to be approved by PI) 3.
Karnofsky Performance Status ≥ 60% for patients 16 years and older and Lansky Play Score ≥ 60 for patients under 16 years of age (Appendix 1) 4. Evaluation of organ status as per MCW BMT SOP. 5. Infectious disease criteria: No active untreated infection. Patients with possible fungal infections must have had at least 2 weeks of appropriate anti-fungal antibiotics and be asymptomatic. 6. Signed consent by parent/guardian or able to give consent if ≥18 years. 7. Negative pregnancy test for patients capable of childbearing potential. 8. Sexually active patients capable of child-bearing potential must agree to use adequate contraception (diaphragm, birth control pills, injections, intrauterine device [IUD], surgical sterilization, subcutaneous implants, or abstinence, etc.) for the duration of treatment. Sexually active men must agree to use barrier contraceptive for the duration of treatment. Donor Eligibility: 1. Unrelated donor meets National Marrow Donor Program criteria for donation. 2. Infectious disease testing. 3. MCW BMT procedures apply for determining donor eligibility, including donor screening and testing for relevant communicable disease agents and diseases. 4. Only Peripheral blood stem cells will be used for stem cell source on this study therefore donor must be willing to undergo G-CSF mobilization and stem cell apheresis. Donor matching. High resolution typing at all loci to be performed. 5. Unrelated Donor: a. HLA typing of at least 10 alleles is required. Donor must be matched at 9/10 or 10/10 alleles (HLA A, B, C, DRB1, DQB1).Donor and collection center willing to undergo mobilization and apheresis. 6. Haploidentical Related Donor: 1. Haploidentical parent or other related donor: Minimum match level full haploidentical (at least 5/10; HLA A, B, C, DRB1, DQB1 alleles), but use of haploidentical donors with extra matches (e.g. 6, 7, or 8/10) encouraged.

Exclusion Criteria:

1. Patients who do not meet disease, organ, or infectious criteria. 2. No suitable donor. 3. Pregnant or lactating patients are ineligible as many of the medications used in this protocol could be harmful to unborn children and infants. 4. Receiving concomitant chemotherapy, radiation therapy; immunotherapy or other anti-cancer therapy for treatment of disease other than is specified in the protocol. Maintenance or other post-HCT therapy can be considered after discussion with the study PI. 5. Participating in a concomitant Phase 1 or 2 study involving treatment of disease. 6. Active malignancy other than eligible disease specified in the protocol. Patients with prior malignancy can be eligible as long as at least 1 year post treatment for that malignancy.

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.

NCT05794880
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.

N/A
Lead Sponsor

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

Medical College of Wisconsin
Principal Investigator

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

N/A
Principal Investigator Affiliation N/A
Agency Class

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

Other
Overall Status Recruiting
Countries United States
Conditions

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

Leukemia, Acute Myeloid Leukemia in Remission, Myelodysplasia, Acute Lymphoblastic Leukemia in Remission, Chronic Myelogenous Leukemia - Chronic Phase, Chronic Myelogenous Leukemia, Accelerated Phase, Chronic Myelogenous Leukemia With Crisis of Blast Cells, Biphenotypic Acute Leukemia, Lymphoblastic Lymphoma, Burkitt Lymphoma, Burkitt Leukemia, Lymphoma After Relapse, Other Malignant Hematologic Diseases in Remission
Arms & Interventions

Arms

Experimental: Alpha/Beta T cell depletion (TCD) plus CD19+ depletion

Alpha beta T cell and B cell depleted allogeneic transplantation with individualized dosing of ATG for patients with hematologic malignancies

Interventions

Device: - Magnetic-Activated Cell Sorter (CliniMACS, Miltenyi)

Participants in this study will receive a blood stem cell transplant, which will use an investigational device called the CliniMACs device to remove alpha/beta T cells and B cells from the blood cells collected from the donor. This is called T cell depletion and B cell depletion.

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.

Children's Wisconsin, Milwaukee, Wisconsin

Status

Recruiting

Address

Children's Wisconsin

Milwaukee, Wisconsin, 53226

Site Contact

Meredith Beversdorf, RN

[email protected]

414-266-5891

Nearest Location

Site Contact

Meredith Beversdorf, RN

[email protected]

414-266-5891

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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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