RecruitingNot applicable

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
0 Years to 25 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study is for people younger than 25 with certain blood cancers who need a stem cell transplant from an unrelated or partly matched family donor. It tests removing certain immune cells from donated stem cells and tailoring the dose of a drug called ATG based on blood cell counts. Researchers will study whether the transplant takes hold, whether donor cells attack the body, and how long patients stay free of disease.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be younger than 25.
  • Have an eligible leukemia, lymphoma, myelodysplasia (a bone marrow disease), or another approved blood cancer. Most must be in remission (no signs of active cancer) or have no disease found by tests for tiny amounts of cancer.
  • Score at least 60 on the age-based scale used to measure daily activity or play.
  • Have organs checked under the transplant center’s rules.
  • Have no active, untreated infection. For a possible fungal infection, have at least 2 weeks of suitable treatment and no symptoms.
  • Have a suitable unrelated or partly matched family donor who passes screening and agrees to donate stem cells collected from blood.
  • Have signed consent from a parent or guardian, or give your own consent if you are 18 or older.
  • If able to become pregnant, have a negative pregnancy test and agree to birth control during treatment if sexually active. Sexually active men must use barrier birth control, such as condoms.

Who can't join

  • Do not meet the study’s disease, organ health, or infection rules.
  • Do not have a suitable donor.
  • Are pregnant or breastfeeding.
  • Are receiving cancer treatment outside the study plan. Some treatment after transplant may be considered after discussion with the study leader.
  • Are also in a phase 1 or phase 2 study treating the disease.
  • Have another active cancer. If you had another cancer in the past, its treatment must have ended at least 1 year ago.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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.

Study sites (1)

WI