Clinical trial
Tacrolimus and Methotrexate With or Without Sirolimus in Preventing…
NCT00382109 · Children's Oncology Group, Other · Completed
Key facts
| NCT number | NCT00382109 |
|---|---|
| Title | Tacrolimus and Methotrexate With or Without Sirolimus in Preventing Graft-Versus-Host Disease in Young Patients Undergoing Donor Stem Cell Transplant for Acute Lymphoblastic Leukemia in Complete Remission |
| Official title | A Randomized Trial of Sirolimus-Based Graft Versus Host Disease Prophylaxis After Hematopoietic Stem Cell Transplantation in Relapsed Acute Lymphoblastic Leukemia |
| Lead sponsor | Children's Oncology Group, Other |
| Collaborators | National Cancer Institute (NCI) NIH |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | B-cell Childhood Acute Lymphoblastic Leukemia, Childhood Acute Lymphoblastic Leukemia in Remission, Graft Versus Host Disease, L1 Childhood Acute Lymphoblastic Leukemia, L2 Childhood Acute Lymphoblastic Leukemia, T-cell Childhood Acute Lymphoblastic Leukemia |
| Intervention type | Drug, Radiation |
| Interventions | thiotepa, cyclophosphamide, tacrolimus, methotrexate, sirolimus, total body irradiation |
| Enrollment | 146 |
| Start date | Mar 1, 2007 |
| Primary completion | May 1, 2011 |
| Completion | Jun 30, 2017 |
| First posted | Sep 28, 2006 |
| Last update posted | Aug 7, 2019 |
| Countries | Australia, Canada, United States |
At a glance
- 10–99 Study sites
- Yes Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: