Different Therapies in Treating Infants With Newly Diagnosed Acute Leukemia
Summary
RATIONALE: Giving chemotherapy before a donor stem cell transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving cyclosporine, methotrexate, leucovorin, and antithymocyte globulin before and after transplant may stop this from happening. It is not yet known which treatment regimen is most effective in treating acute leukemia. PURPOSE: This randomized clinical trial is studying how well different therapies work in treating infants with newly diagnosed acute leukemia.
Timeline
- Start
- 2006-01
- Primary completion
- 2020-12
- Completion
- —
Publications
- Stutterheim J, van der Sluis IM, de Lorenzo P, Alten J, Ancliffe P, Attarbaschi A, Brethon B, Biondi A, Campbell M, Cazzaniga G, Escherich G, Ferster A, Kotecha RS, Lausen B, Li CK, Lo Nigro L, Locatelli F, Marschalek R, Meyer C, Schrappe M, Stary J, Vora A, Zuna J, van der Velden VHJ, Szczepanski T, Valsecchi MG, Pieters R. Clinical Implications of Minimal Residual Disease Detection in Infants With KMT2A-Rearranged Acute Lymphoblastic Leukemia Treated on the Interfant-06 Protocol. J Clin Oncol. 2021 Feb 20;39(6):652-662. doi: 10.1200/JCO.20.02333. Epub 2021 Jan 6.
- Pieters R, De Lorenzo P, Ancliffe P, Aversa LA, Brethon B, Biondi A, Campbell M, Escherich G, Ferster A, Gardner RA, Kotecha RS, Lausen B, Li CK, Locatelli F, Attarbaschi A, Peters C, Rubnitz JE, Silverman LB, Stary J, Szczepanski T, Vora A, Schrappe M, Valsecchi MG. Outcome of Infants Younger Than 1 Year With Acute Lymphoblastic Leukemia Treated With the Interfant-06 Protocol: Results From an International Phase III Randomized Study. J Clin Oncol. 2019 Sep 1;37(25):2246-2256. doi: 10.1200/JCO.19.00261. Epub 2019 Jul 8.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cytarabine | Small molecule | — | Intravenous |
| Subject | Daunorubicin | Small molecule | — | Intravenous |
| Subject | Etoposide | Small molecule | — | Intravenous |
| Subject | Mitoxantrone | Small molecule | — | Intravenous |
| Background | ANTILYMPHOCYTE IMMUNOGLOBULIN (HORSE) | Protein / enzyme biologic | — | Intravenous |
| Background | Busulfan | Small molecule | — | Oral |
| Background | Cyclophosphamide | Other / unclassified | — | Intravenous |
| Background | Cyclosporine | Peptide | — | Intravenous |
| Background | Hydrocortisone | Other / unclassified | — | Intrathecal |
| Background | Leucovorin | Small molecule | — | Oral |
| Background | MERCAPTOPURINE ANHYDROUS | Small molecule | — | Oral |
| Background | Melphalan | Small molecule | — | Intravenous |
| Background | Methotrexate | Small molecule | — | Intrathecal |
| Background | Pegaspargase | Protein / enzyme biologic | — | Intravenous |
| Background | Prednisolone | Other / unclassified | — | Intrathecal |
| Background | Prednisone | Other / unclassified | — | Oral |
| Background | Thioguanine | Small molecule | — | Oral |
| Background | Vincristine | Small molecule | — | Intravenous |
| Background | asparaginase | Protein / enzyme biologic | — | Intravenous |