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Flotetuzumab for the Treatment of Relapsed or Refractory Advanced CD123-Positive Hematological Malignancies

NCT04681105 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2026-01-28

No results posted yet for this study

Summary

This phase I trial studies the best dose and side effects of flotetuzumab for the treatment of patients with blood cancers (hematological malignancies) that have spread to other places in the body (advanced) and have come back after a period of improvement (relapsed) or does not respond to treatment (refractory). Flotetuzumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread.

Conditions

  • Recurrent Acute Leukemia
  • Recurrent B Acute Lymphoblastic Leukemia
  • Recurrent Blastic Plasmacytoid Dendritic Cell Neoplasm
  • Recurrent Chronic Myelogenous Leukemia, BCR-ABL1 Positive
  • Recurrent Hairy Cell Leukemia
  • Recurrent Hematologic Malignancy
  • Recurrent Hodgkin Lymphoma
  • Recurrent T Acute Lymphoblastic Leukemia
  • Refractory Acute Leukemia
  • Refractory B Acute Lymphoblastic Leukemia
  • Refractory Blastic Plasmacytoid Dendritic Cell Neoplasm
  • Refractory Chronic Myelogenous Leukemia, BCR-ABL1 Positive
  • Refractory Hairy Cell Leukemia
  • Refractory Hematologic Malignancy
  • Refractory Hodgkin Lymphoma
  • Refractory T Acute Lymphoblastic Leukemia
  • Systemic Mastocytosis

Interventions

DRUG

Acetaminophen

Given PO

DRUG

Dexamethasone

Given IV

DRUG

Diphenhydramine

Given IV or PO

BIOLOGICAL

Flotetuzumab

Given IV

DRUG

Ibuprofen

Given PO

DRUG

Ranitidine

Given IV

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • City of Hope Medical Center

    lead OTHER

Principal Investigators

  • Ibrahim T Aldoss · City of Hope Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-18
Primary Completion
2025-08-05
Completion
2025-08-05
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04681105 on ClinicalTrials.gov