Flotetuzumab in Treating Patients With Recurrent or Refractory CD123 Positive Blood Cancer

Acute Leukemia Clinical Trial

Official title: A Phase 2 Study to Evaluate the Anti-Tumor Activity of Single Agent Flotetuzumab in Advanced CD123-Positive Hematological Malignancies

Status Withdrawn

Clinical Trial Summary

This phase II trial studies how well flotetuzumab works in treating patients with CD123 positive blood cancer that has come back or does not respond to treatment. Immunotherapy with monoclonal antibodies, such as flotetuzumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

Clinical Trial Description

PRIMARY OBJECTIVES:

I. Evaluate the anti-tumor activity of flotetuzumab in CD123-positive advanced acute lymphoblastic leukemia (ALL) (Cohort A) and other hematological malignancies (Cohort B), as assessed by complete remission (complete remission [CR]/complete remission with incomplete count recovery [CRi]/complete remission with partial hematological recovery [CRh]) rate.

SECONDARY OBJECTIVES:

I. Evaluate toxicity profile of flotetuzumab. II. Evaluate remission duration among responders. III. Estimate 1-year overall survival. IV. Evaluate minimal residual disease (MRD) status in responders in the ALL cohort.

V. Evaluate the percentage of patients who receive subsequent allogeneic transplantation.

EXPLORATORY OBJECTIVES:

I. Examine immune profile pre- and post-treatment with flotetuzumab. II. Assess the association between CD123 expression and tumor response. III. Assess the association between alterations in tumor genetic or microenvironment with response.

IV. Assess cytokine levels during therapy.

OUTLINE:

Patients receive flotetuzumab intravenously (IV) continuously for 28 days. Patients who achieve partial response or stable disease or any clinical benefit (partial remission [PR], stable disease [SD]) that did not meet CR, CRi, CRh or morphologic leukemia free state (MLFS) criteria receive a second 28-day continuous flotetuzumab IV infusion. Patients who achieve CR/CRi/CRh/MLFS after course 1 or course 2 receive flotetuzumab IV at a 4 days on-3 days off schedule. 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 at 30 days and then up to 1 year. ;

Related Conditions & MeSH terms

• Acute Biphenotypic Leukemia
• Acute Leukemia
• Chronic Myelogenous Leukemia, BCR-ABL1 Positive
• Hairy Cell Leukemia
• Hematologic Neoplasms
• Hodgkin Disease
• Interleukin-3 Receptor Subunit Alpha Positive
• Leukemia
• Leukemia, Biphenotypic, Acute
• Leukemia, Hairy Cell
• Leukemia, Lymphoid
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid
• Lymphoma
• Mastocytosis
• Neoplasms
• Precursor Cell Lymphoblastic Leukemia-Lymphoma
• Recurrent Acute Lymphoblastic Leukemia
• Recurrent Blastic Plasmacytoid Dendritic Cell Neoplasm
• Recurrent Chronic Myelogenous Leukemia, BCR-ABL1 Positive
• Recurrent Hematologic Malignancy
• Recurrent Hodgkin Lymphoma
• Refractory Acute Lymphoblastic Leukemia
• Refractory Blastic Plasmacytoid Dendritic Cell Neoplasm
• Refractory Hematologic Malignancy
• Refractory Hodgkin Lymphoma
• Systemic Mastocytosis

• NCT number: NCT03739606
• Study type: Interventional
• Source: City of Hope Medical Center
• Status: Withdrawn
• Phase: Phase 2
• Start date: October 20, 2020
• Completion date: October 20, 2020