Flotetuzumab for Refractory Hematologic Malignancy

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Refractory Hematologic Malignancy+16 MoreFlotetuzumab - Biological
Eligibility
Any Age
All Sexes
What conditions do you have?
Select

Study Summary

This trial is studying the best dose and side effects of flotetuzumab for treating patients with relapsed or refractory blood cancers. Flotetuzumab is an antibody that may interfere with cancer cells' ability to grow and spread.

Eligible Conditions
  • Refractory Hematologic Malignancy
  • Refractory T-Cell Acute Lymphoblastic Leukemia
  • Refractory Hodgkin Lymphoma
  • Acute Lymphoblastic Leukemia (ALL)
  • Refractory B Acute Lymphoblastic Leukemia
  • Recurrent Blastic Plasmacytoid Dendritic Cell Neoplasm
  • Chronic Myelogenous Leukemia (CML)
  • Hairy Cell Leukemia
  • Hodgkin Lymphoma
  • B-Cell Acute Lymphoblastic Leukemia (ALL)
  • Refractory Blastic Plasmacytoid Dendritic Cell Neoplasm
  • Recurrent Hematologic Malignancy
  • Refractory Acute Leukemia
  • Systemic Mastocytosis
  • Acute Leukemia

Treatment Effectiveness

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: Up to 1 year

Up to 1 year
Duration of remission
Minimal residual disease
Number/percent who bridge to allogeneic hematopoietic cell transplantation (HCT)
Overall survival
Day 30
Incidence of adverse events
Day 28
Best response of complete remission attained

Trial Safety

Trial Design

1 Treatment Group

Treatment (flotetuzumab)
1 of 1

Experimental Treatment

40 Total Participants · 1 Treatment Group

Primary Treatment: Flotetuzumab · No Placebo Group · Phase 1

Treatment (flotetuzumab)Experimental Group · 6 Interventions: Flotetuzumab, Diphenhydramine, Dexamethasone, Ibuprofen, Ranitidine, Acetaminophen · Intervention Types: Biological, Drug, Drug, Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Diphenhydramine
FDA approved
Dexamethasone
FDA approved
Ibuprofen
FDA approved
Ranitidine
FDA approved
Acetaminophen
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 1 year

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor
517 Previous Clinical Trials
2,249,561 Total Patients Enrolled
1 Trials studying Refractory Hematologic Malignancy
National Cancer Institute (NCI)NIH
13,084 Previous Clinical Trials
41,141,439 Total Patients Enrolled
1 Trials studying Refractory Hematologic Malignancy
Ibrahim T AldossPrincipal InvestigatorCity of Hope Medical Center
1 Previous Clinical Trials
6 Total Patients Enrolled

Eligibility Criteria

Age Any Age · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Cohort A: Acute lymphoblastic leukemia.
If available, exceptions may be granted with study principal investigator (PI) approval.
You have documented informed consent of the participant and/or legally authorized representative.
You have T-cell phenotype: patients with relapsed or refractory who have received at least 1 prior regimen.
You have relapsed or refractory ALL and have received at least 2 prior regimens and failed or are ineligible for CD19-based targeted therapy.