NCT07072585 — drugset

Summary

This phase II/III trial tests the addition of daratumumab to chemotherapy for treating patients with newly-diagnosed T-ALL and T-LL. Daratumumab is in a class of medications called monoclonal antibodies. It binds to a protein called CD38, which is found on some types of immune cells and cancer cells. Daratumumab may block CD38 and help the immune system kill cancer cells. Chemotherapy drugs work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy with daratumumab may kill more cancer cells.

Timeline

Start: 2026-08-28
Primary completion: 2035-09-01
Completion: 2035-09-01

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Daratumab	Monoclonal antibody	—	Intravenous
Background	Bortezomib	Small molecule	—	Intravenous
Background	Calaspargase Pegol	Protein / enzyme biologic	—	Intravenous
Background	Cyclophosphamide	Other / unclassified	—	Intravenous
Background	Cytarabine	Small molecule	—	Intrathecal
Background	Daunorubicin	Small molecule	—	Intravenous
Background	Dexamethasone	Small molecule	—	Oral
Background	Doxorubicin	Other / unclassified	—	Intravenous
Background	Hydrocortisone	Other / unclassified	—	Intrathecal
Background	MERCAPTOPURINE ANHYDROUS	Small molecule	—	Oral
Background	Methotrexate	Small molecule	—	Intrathecal
Background	Methylprednisolone	Other / unclassified	—	Intravenous
Background	Nelarabine	Small molecule	—	Intravenous
Background	Pegaspargase	Protein / enzyme biologic	—	Intravenous
Background	Prednisolone	Other / unclassified	—	Oral
Background	Prednisone	Other / unclassified	—	Oral
Background	Thioguanine	Small molecule	—	Oral
Background	Vincristine	Small molecule	—	Intravenous

Testing the Addition of Daratumumab to Chemotherapy for Treating Patients With Newly-Diagnosed T-Cell Lymphoblastic Leukemia (T-ALL) and T-Cell Lymphoblastic Lymphoma (T-LL)

Summary

Timeline

Drugs

Indications