What this study is
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
What's being tested
- Magnetic-Activated Cell Sorter (CliniMACS, Miltenyi)
Intervention · DEVICE
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.
Study details
- Official title
- Matched Unrelated Donor and Partially Matched Related Donor Peripheral Stem Cell Transplantation With Alpha/Beta T-Cell and B-Cell Depletion for Patients With Hematologic Malignancies With Targeted ATG Dosing Pilot Study, IDE 13641
- Sponsor
- Medical College of Wisconsin
- Conditions
- 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
- Enrolling
- 40 people
- Starts
- 2023-05-01
- Est. completion
- 2032-05
- Design
- Open-label, single group
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 0 Years – 25 YearsSex ALLHealthy volunteers Not acceptedAll participants
You may qualify if
- Patient age < 25 years. Both genders and all races eligible.
- 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)
- Karnofsky Performance Status ≥ 60% for patients 16 years and older and Lansky Play Score ≥ 60 for patients under 16 years of age (Appendix 1)
- Evaluation of organ status as per MCW BMT SOP
- 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.
- Signed consent by parent/guardian or able to give consent if ≥18 years.
- Negative pregnancy test for patients capable of childbearing potential
- 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.
You can't join if
- Patients who do not meet disease, organ, or infectious criteria.
- No suitable donor
- Pregnant or lactating patients are ineligible as many of the medications used in this protocol could be harmful to unborn children and infants
- 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.
- Participating in a concomitant Phase 1 or 2 study involving treatment of disease
- 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.
Donor Eligibility
You may qualify if
- Unrelated donor meets National Marrow Donor Program criteria for donation
- Infectious disease testing
- MCW BMT procedures apply for determining donor eligibility, including donor screening and testing for relevant communicable disease agents and diseases.
- 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.
- 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
- Haploidentical Related Donor:; 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openChildren's Wisconsin
Milwaukee, Wisconsin, United States
- Meredith Beversdorf, RN · Contact414-266-5891mbeversdorf@childrenswi.org
- Amy Moskop · Principal investigator
Recruiting
Study team
Sponsor
Medical College of Wisconsin
Study ID IIT-MOSKOP-MABD
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.