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Reduced Intensity Haploidentical BMT for High Risk Solid Tumors

StatusRecruiting
PhasePhase 2
Started2013-03-27
View on ClinicalTrials.gov ↗

Amendment history

2026-03-11
Study Status, Contacts/Locations v19
Study sites4→3
2025-03-06
Study Status v18
Re-verified, no change to tracked fields
2024-06-18
Study Identification, Study Status, Sponsor/Collaborators v17
Collaborators+31 characters
National Cancer Institute (NCI)
2024-03-26
Study Status, Contacts/Locations v16
Study sites5→4
2024-01-03
Study Status v15
Primary completion date2024-01→2027-01
Completion date2025-01→2030-01
Show 14 earlier versions
2023-04-19
Study Status, Contacts/Locations v14
Re-verified, no change to tracked fields
2022-08-12
Study Status, Contacts/Locations v13
Study sitesdetails revised at 1 of 5 sites
2022-06-23
Study Status v12
Re-verified, no change to tracked fields
2021-10-29
Study Status, Contacts/Locations v11
Study sitesdetails revised at 1 of 5 sites
2021-04-12
Study Status v10
Re-verified, no change to tracked fields
2020-05-21
Study Status, Contacts/Locations v9
Study sites4→5
2020-05-01
Study Status, Arms and Interventions, Outcome Measures, Contacts/Locations v8
Secondary endpoints11 to 10 entries
engraftment
Primary endpoints1 entry, revised
Safety of Shortened duration of tacrolimus as assessed by number of participants with NRM and Grade III-IV acute GVHD at Day 120
Study sitesdetails revised at 1 of 4 sites
2020-04-10
Study Status v7
Primary completion date2020-12→2024-01
Completion date2020-12→2025-01
2020-01-21
Study Status, Contacts/Locations v6
Study sites4 entries, revised
AlbertNew EinsteinYork CollegeMedical ofCenter/ MedicineMaria Fareri Children's Hospital
2020-01-13
Study Status, Contacts/Locations v5
Study sites1→4
2019-04-26
Study Identification, Study Status, Study Description, Conditions, Study Design, Arms and Interventions, Outcome Measures, Eligibility v4
Primary completion date2019-12→2020-12
Start date2013-03-20→2013-03-27
Enrollment target20→60
InterventionsCyclophosphamide (Drug), Fludarabine (Drug), Melphalan (Drug), Sirolimus (Drug), low dose total body irradiation (Radiation)→Cyclophosphamide (Drug), Fludarabine (Drug), Melphalan (Drug), Tacrolimus (Drug), low dose total body irradiation (Radiation)
Eligibility criteria-52 characters
InclusionPresence Criteria:of a suitable related HLA-haploidentical bone marrow donor.a. PatientsThe donor and recipient must havebe anidentical at at least one allele of each of the following genetic loci: HLA-mismatchedA, relatedHLA-B, HLA-Cw, HLA-DRB1, and HLA-DQB1. A minimum match of 5/10 is therefore required, and will be considered sufficient evidence that the donor (3/6and torecipient 5/6share i.e., 3 to 6 antigen match). Patients who have inherited a recombinantone HLA haplotype may receive marrow from parent in whose gamete the recombination occurred. Sarcoma1 patients: Males and Fema [...] [...]
Secondary endpoints3 to 11 entries
Overall survival at 6 months Overall survival at 1 year Event-free survival at 6 months Event-free survival at 1 year progression-free survival at 6 months progression-free survival at 1 year engraftment acute GVHD chronic GVHD
Primary endpoints1 entry, revised
DonorSafety cellof engraftmentShortened duration of tacrolimus as assessed by number of participants with NRM and Grade III-IV acute GVHD
Study description+7,726 characters
[...] steosarcoma, rhabdomyosarcoma, melanoma and hepatoblastoma. OurThe investigators' goal is to maximize a T cell and NK cell mediated graft ver [...] osuppression regimen containing post transplantation Cy and anshortened mTORduration inhibitortacrolimus. This therapy will be widely applicable because almost all [...] ts have a half-matched donor available (parent or sibling). WeThe investigators hope to demonstrate the safety and feasibility of this ther [...] ombining this platform with additional post-transplantation relapse/progression prevention therapy such as cryoablationan immune checkpoint inhibitor. TREAT [...] [...]
Study title-26 characters
Trial of Reduced Intensity Conditioning and Haploidentical BMT for High-risk Risk Solid Tumors
2018-11-20
Study Identification, Study Status v3
Primary completion date2017-12→2019-12
Completion date2018-12→2020-12
Start date2013-02→2013-03-20
Study title-11 characters
A Phase II Trial of Reduced Intensity Conditioning and Haploidentical BMT for High-risk Solid Tumors
2016-06-16
Study Status v2
Primary completion date2015-12→2017-12
Completion date2016-12→2018-12
2013-03-18
Study Status, Outcome Measures, Eligibility v1
Eligibility criteria+1 characters
[...] et eligibility requirements/organ function requirements for myeloablativeconditioningmyeloablative conditioning; Patients with >5 identified lesions on the end of inductio [...]
Secondary endpoints1 to 3 entries
Overall survival, Relapse Non-Relapse relapse, mortality.Mortality
2013-03-01
Original filing
The purpose of this study is to see if giving reduced intensity chemotherapy, haploidentical bone marrow, post-transplant cyclophosphamide and shortened duration tacrolimus is safe and feasible for patients with very high-risk solid tumors.
Trial Details
NCT Number NCT01804634
Lead Sponsor Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators: National Cancer Institute (NCI)
Conditions Refractory and/or Relapsed Metastatic Solid Tumors
Enrollment 60 participants
Start Date 2013-03-27
Primary Completion 2027-01 (estimated)
Study Completion 2030-01 (estimated)
Updated on ClinicalTrials.gov 2026-03-13