Hematopoietic System--Cancer Clinical Trial
Official title:
Modified Post-Transplant Cyclophosphamide Combined With DCAG as a Bridge Followed by Busulfan, Fludarabine and Melphalan Based Conditioning Regimen for Children With Juvenile Myelomonocytic Leukemia
Verified date | September 2018 |
Source | Capital Research Institute of Pediatrics |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
Hematopoietic stem cell transplantation (HSCT) is the only curative option for most of juvenile myelomonocytic leukemia (JMML). However, relapse after HSCT severely influence the long-term overall survival (OS). Researches demonstrate that these malignant myeloid disorders is a particular responsiveness to epigenetic therapy with the DNA-hypomethylating agents decitabine. However, hypomethylating therapy does not eradicate the malignant clone in JMML and an emerging concept with intriguing potential is the combination of hypomethylating therapy and HSCT. Graft-versus-host disease (GVHD) is major complication after HSCT as a threshold of the quality of patient life. Many data indicate that post -transplant cyclophosphamide (PT/Cy) is an effective method to control the occurrence of GVHD.
Status | Enrolling by invitation |
Enrollment | 6 |
Est. completion date | April 10, 2020 |
Est. primary completion date | July 10, 2018 |
Accepts healthy volunteers | |
Gender | All |
Age group | 1 Year to 18 Years |
Eligibility |
Inclusion Criteria: - JMML patients diagnosed in our center and with the indications of transplant without the suitable donor. Exclusion Criteria: - JMML patients do not need to transplant. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Capital Research Institute of Pediatrics |
Dvorak CC, Satwani P, Stieglitz E, Cairo MS, Dang H, Pei Q, Gao Y, Wall D, Mazor T, Olshen AB, Parker JS, Kahwash S, Hirsch B, Raimondi S, Patel N, Skeens M, Cooper T, Mehta PA, Grupp SA, Loh ML. Disease burden and conditioning regimens in ASCT1221, a ran — View Citation
Flotho C, Sommer S, Lübbert M. DNA-hypomethylating agents as epigenetic therapy before and after allogeneic hematopoietic stem cell transplantation in myelodysplastic syndromes and juvenile myelomonocytic leukemia. Semin Cancer Biol. 2018 Aug;51:68-79. do — View Citation
Locatelli F, Niemeyer CM. How I treat juvenile myelomonocytic leukemia. Blood. 2015 Feb 12;125(7):1083-90. doi: 10.1182/blood-2014-08-550483. Epub 2015 Jan 6. Review. — View Citation
Zaucha-Prazmo A, Gozdzik J, Debski R, Drabko K, Sadurska E, Kowalczyk JR. Transplant-related mortality and survival in children with malignancies treated with allogeneic hematopoietic stem cell transplantation. A multicenter analysis. Pediatr Transplant. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | disease statue | Disease status can be measured by test the of (minimal residual disease) MRD, MRD<0,01% as negative. The quantitative of gene mutation is "0" as negative. | one months |
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