RECRUITING

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

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

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

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

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

Quick Facts

Study Start:2023-05-01

Study Completion:2032-05

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05794880

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:0 Years to 25 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion 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. 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: 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.	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.

Inclusion Criteria

Exclusion 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.
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:
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.

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.

Contacts and Locations

Study Contact

Meredith Beversdorf, RN

CONTACT

414-266-5891

mbeversdorf@childrenswi.org

Study Locations (Sites)

Children's Wisconsin

Milwaukee, Wisconsin, 53226

United States

Collaborators and Investigators

Sponsor: Medical College of Wisconsin

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 Date2023-05-01

Study Completion Date2032-05

Study Record Updates

Study Start Date2023-05-01

Study Completion Date2032-05

Terms related to this study

Additional Relevant MeSH Terms

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