NCT01925131

S1312, Inotuzumab Ozogamicin and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Acute Leukemia

S1312, A Phase I Study of Inotuzumab Ozogamicin (NSC-772518) in Combination With CVP (Cyclophosphamide, Vincristine, Prednisone) for Patients With Relapsed/Refractory CD22-Positive Acute Leukemia (Including B-ALL, Mixed Phenotypic Leukemia, and Burkitt's Leukemia)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: SWOG Cancer Research Network · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I trial studies the side effects and best dose of inotuzumab ozogamicin when given together with combination chemotherapy in treating patients with relapsed or refractory acute leukemia. Immunotoxins, such as inotuzumab ozogamicin, can find cancer cells that express cluster of differentiation (CD)22 and kill them without harming normal cells. Drugs used in chemotherapy, such as cyclophosphamide, vincristine sulfate, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving inotuzumab ozogamicin together with combination chemotherapy may kill more cancer cells.

Detailed description

PRIMARY OBJECTIVES: I. To assess the safety of inotuzumab ozogamicin in combination with cyclophosphamide, vincristine (vincristine sulfate) and prednisone (CVP) and to determine the maximum tolerated dose (MTD) of inotuzumab ozogamicin in this regimen for patients with relapsed or refractory CD22+ acute leukemia (B-cell acute lymphoblastic leukemia \[B-ALL\], mixed phenotype, and Burkitt's). SECONDARY OBJECTIVES: I. To estimate the preliminary activity (response rate: complete remission \[CR\] + complete remission with incomplete count recovery \[CRi\]) of this combination in the expansion cohort. II. To estimate the frequency and severity of toxicities of this combination in this patient population. OUTLINE: This is a dose-escalation study of inotuzumab ozogamicin. Patients receive cyclophosphamide intravenously (IV) on day 1, vincristine sulfate IV on day 1, prednisone orally (PO) on days 1-5, and inotuzumab ozogamicin IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 2 months for 1 year, every 3 months for 1 year, and then every 6 months for 1 year.

Conditions

• Acute Leukemias of Ambiguous Lineage
• B-cell Adult Acute Lymphoblastic Leukemia
• Philadelphia Chromosome Positive Adult Precursor Acute Lymphoblastic Leukemia
• Recurrent Adult Acute Lymphoblastic Leukemia
• Recurrent Adult Burkitt Lymphoma

Interventions

Type	Name	Description
DRUG	cyclophosphamide	Given IV
DRUG	vincristine sulfate	Given IV
DRUG	prednisone	Given PO
BIOLOGICAL	inotuzumab ozogamicin	Given IV
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2014-06-13
• Primary completion: 2022-01-01
• Completion: 2023-01-01
• First posted: 2013-08-19
• Last updated: 2023-05-03
• Results posted: 2022-04-06

Locations

5 sites across 1 country: United States