NCT03991884

Inotuzumab Ozogamicin and Chemotherapy in Treating Patients With Recurrent or Refractory B-cell Acute Lymphoblastic Leukemia

A Phase I Study of Dose-Adjusted Etoposide, Prednisone, Vincristine, Cyclophosphamide, and Doxorubicin Plus Escalating Doses of Inotuzumab Ozogamicin (DA-EPOCH-InO) in Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I trial studies the best dose of inotuzumab ozogamicin in combination with chemotherapy in treating patients with B-cell acute lymphoblastic leukemia that has come back (recurrent) or that does not respond to treatment (refractory). Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a toxic agent called ozogamicin. Inotuzumab attaches to CD22 positive cancer cells in a targeted way and delivers ozogamicin to kill them. Drugs used in chemotherapy, such as etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin, 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 inotuzumab ozogamicin in combination with chemotherapy may kill more cancer cells than with chemotherapy alone in treating patients with recurrent or refractory B-cell acute lymphoblastic leukemia.

Detailed description

This is a dose-escalation study of inotuzumab ozogamicin. Patients receive etoposide, doxorubicin, and vincristine intravenously (IV) via continuous infusion on days 1-4, prednisone orally (PO) or IV twice daily (BID) on days 1-5, and cyclophosphamide IV over 1 hour on day 5. Patients also receive inotuzumab ozogamicin IV over 1 hour on days 8 and 15. Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days then annually for up to 5 years.

Conditions

• Recurrent B Acute Lymphoblastic Leukemia
• Recurrent B Lymphoblastic Lymphoma
• Refractory B Acute Lymphoblastic Leukemia
• Refractory B Lymphoblastic Lymphoma

Interventions

Type	Name	Description
DRUG	Etoposide	Given IV
DRUG	Doxorubicin	Given IV
DRUG	Vincristine	Given IV
DRUG	Prednisone	Given PO or IV
DRUG	Cyclophosphamide	Given IV
BIOLOGICAL	Inotuzumab Ozogamicin	Given IV

Timeline

• Start date: 2019-09-24
• Primary completion: 2022-10-20
• Completion: 2023-06-28
• First posted: 2019-06-19
• Last updated: 2023-07-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study