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

—

Outcome

Missed primary endpoint

paper The 6-year probability of disease-free survival was comparable for the randomized arms (ADE+MAE 39.3% [SE 4.0; n = 169] v IB 36.8% [SE, 3.9; n = 161]; log-rank P = .47). PMID 31283407 ↗

paper Early intensification with postinduction myeloid-type chemotherapy courses did not significantly improve outcome for infant ALL compared with the lymphoid-type course IB. PMID 31283407 ↗

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	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
Background	therapeutic hydrocortisone	Unknown	—	Intrathecal

Indications