Reduced Intensity Haploidentical BMT for High Risk Solid Tumors (NCT01804634) | Clinical Trial Compass
RecruitingPhase 2
Reduced Intensity Haploidentical BMT for High Risk Solid Tumors
United States60 participantsStarted 2013-03-27
Plain-language summary
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.
Who can participate
Age range1 Year – 50 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Presence of a suitable related HLA-haploidentical bone marrow donor.a. The donor and recipient must be identical at at least one allele of each of the following genetic loci: HLA-A, HLA-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 and recipient share one HLA haplotype.
1 year-50 years
Patients must have a confirmed histopathologic diagnosis and be classified as high risk defined by having an expected survival of \< 10%. Examples include:
* Neuroblastoma or ganglioneuroblastoma
* Failure to achieve at least a PR after induction therapy with COG ANBL0532 or standard chemotherapy
* Refractory to induction chemotherapy with COG ANBL0532 or standard chemotherapy
* Patients with high risk disease as defined in Appendix 1 whose autologous peripheral blood stem cell product is contaminated with neuroblastoma or who do not have an autologous product available
* Patients with high risk disease as defined in Appendix 1 who do not meet eligibility requirements/organ function requirements for myeloablative conditioning. Patients with \>5 identified lesions on the end of induction (COG ANBL0532 or standard chemotherapy) MIBG scan
* Stage 4 rhabdomyosarcoma
* Metastatic Ewing Sarcoma
* Osteosarcoma with metastatic disease beyond the lungs and/or with lung metastases not amenable to resection
* Desmoplastic small round cell tumor
* Any other solid tumor and soft tissue sarcoma with an e…
What they're measuring
1
Safety of Shortened duration of tacrolimus as assessed by number of participants with NRM and Grade III-IV acute GVHD at Day 120
Timeframe: up to 120 Days
Trial details
NCT IDNCT01804634
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins