← Back to Search

Monoclonal Antibodies

Flotetuzumab for CD123-Positive Hematological Malignancies

Phase 1
Waitlist Available
Led By Ibrahim T Aldoss
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Fully recovered from the acute toxic effects (except alopecia) to =< grade 1 to prior anti-cancer therapy
- Hodgkin lymphoma patients who have failed or relapsed after PD-1/PD-L1- inhibitors and brentuximab vedotin
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights

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.

Who is the study for?
This trial is for adults with advanced blood cancers expressing CD123 who have not responded to standard treatments or whose disease has returned. Eligible participants must meet specific health criteria, including organ function and blood counts, and agree to use effective birth control. Those with recent transplants, untreated autoimmune disorders, active infections, or certain other medical conditions are excluded.Check my eligibility
What is being tested?
The trial is testing the optimal dose and side effects of flotetuzumab in patients with various hematological malignancies that express CD123. Flotetuzumab is a monoclonal antibody designed to inhibit cancer cell growth. The study includes supportive medications like acetaminophen and dexamethasone to manage potential reactions.See study design
What are the potential side effects?
Possible side effects of flotetuzumab may include allergic reactions similar to those caused by compounds related to it. Patients might also experience symptoms from the immune system attacking their own body (autoimmune disorders), infusion-related reactions, or worsening of underlying diseases.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have recovered from side effects of cancer treatment, except for hair loss.
Select...
My Hodgkin lymphoma did not respond to PD-1/PD-L1 inhibitors or brentuximab vedotin.
Select...
My hairy cell leukemia didn't respond to or got worse after purine analog treatment.
Select...
My condition has returned or didn't respond to treatment.
Select...
My BPDCN has returned or didn't respond to the first treatment.
Select...
My white blood cell count is healthy for treatment.
Select...
My BPDCN has returned or didn't respond to the first treatment.
Select...
I have advanced acute leukemia that didn't respond to two previous treatments.
Select...
My blood cancer is CD123+ and has not responded to standard treatments, but it's not AML or MDS.
Select...
My blood cancer is CD123+ and has not responded to standard treatments, but it's not AML or MDS.
Select...
I've had a lumbar puncture to check for brain or spinal cord disease due to concerning symptoms.
Select...
My blood cancer is not responding to standard treatments.
Select...
I have had at least one treatment for my relapsed or refractory T-cell cancer.
Select...
I have CML and cannot use or did not respond to the latest treatment.
Select...
I am capable of becoming pregnant or fathering a child.
Select...
I have had at least one treatment for my relapsed or refractory condition.
Select...
I have recovered from side effects of cancer treatment, except for hair loss.
Select...
My systemic mastocytosis worsened despite midostaurin treatment.
Select...
My tumor tests positive for CD123.
Select...
My tumor tests positive for CD123.
Select...
My lung function tests are within normal limits or my oxygen levels are above 90% without assistance.
Select...
My hairy cell leukemia didn't respond to or got worse after purine analog treatment.
Select...
My white blood cell count is healthy for treatment.
Select...
My acute leukemia is advanced and has not responded to two previous treatments.
Select...
I have CML and cannot use or did not respond to the latest treatment.
Select...
My Hodgkin lymphoma did not respond to PD-1/PD-L1 inhibitors or brentuximab vedotin.
Select...
I am able to get out of my bed or chair and move around.
Select...
I have acute lymphoblastic leukemia.
Select...
My cancer can be measured and is at least 1.5 cm on a scan.
Select...
I have ALL, failed 2 treatments, and can't have CD19 therapy.
Select...
I can take care of myself and am up and about more than 50% of my waking hours.
Select...
My systemic mastocytosis worsened despite taking midostaurin.
Select...
My cancer can be measured and is at least 1.5 cm on a scan.
Select...
I have ALL, failed 2 treatments, and can't have CD19 therapy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of adverse events
Secondary outcome measures
Best response of complete remission attained
Duration of remission
Minimal residual disease
+2 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (flotetuzumab)Experimental Treatment6 Interventions
INDUCTION THERAPY: Patients receive flotetuzumab via continuous IV infusion on days 1-28. Patients who achieve SD/PR (Cohort A) or PR/CI (Cohort B), receive an additional induction cycle. Patients who achieve PR (Cohort A) or PR/CI/MMR (Cohort B) after cycle 2 re-induction, may continue induction therapy for up to 4 more cycles. CONSOLIDATION THERAPY: Patients who achieve CR/CRi/CRh/MLFS (Cohort A) or CR/MR (Cohort B) after cycle 1 or cycle 2 of induction therapy, receive flotetuzumab via continuous IV infusion on days 1-28 for up to 5 and 6 cycles, respectively, in the absence of disease progression or unacceptable toxicity. Patients with PR (Cohort A) or PR/CI/MMR (Cohort B) who have received up to 6 cycles of induction therapy may receive up to 2 cycles of consolidation therapy in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Acetaminophen
2017
Completed Phase 4
~2030
Dexamethasone
2007
Completed Phase 4
~2590
Diphenhydramine
2002
Completed Phase 4
~1170
Ibuprofen
2013
Completed Phase 4
~5800
Ranitidine
2008
Completed Phase 4
~2240

Find a Location

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor
558 Previous Clinical Trials
1,917,439 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,633 Total Patients Enrolled
Ibrahim T AldossPrincipal InvestigatorCity of Hope Medical Center
1 Previous Clinical Trials
6 Total Patients Enrolled

Media Library

Flotetuzumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04681105 — Phase 1
Hematologic Malignancy Research Study Groups: Treatment (flotetuzumab)
Hematologic Malignancy Clinical Trial 2023: Flotetuzumab Highlights & Side Effects. Trial Name: NCT04681105 — Phase 1
Flotetuzumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04681105 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the common medical applications of Flotetuzumab?

"Flotetuzumab is primarily utilized to reduce macular edema, but it has been used as a viable treatment for ulcerative colitis, eye diseases and varicella-zoster virus acute retinal necrosis."

Answered by AI

Are participants being enrolled in this research endeavor?

"Affirmative. Records hosted on clinicaltrials.gov confirm that this scientific trial, which was originally posted on November 18th 2020, is actively seeking participants. 40 individuals are required to be recruited from 1 medical centre."

Answered by AI

Has Flotetuzumab been accepted by the FDA for medicinal use?

"Flotetuzumab has been assigned a safety rating of 1 due to limited evidence that supports its efficacy and the fact that it is only in Phase 1 clinical trials."

Answered by AI

What is the total number of participants involved in this investigation?

"Affirmative. According to information released on clinicaltrials.gov, this medical study is still taking participants since its initial posting date of November 18th 2020 and most recent update at the end of November 2022. 40 individuals are needed from a single enrolment site."

Answered by AI

Have prior experiments been conducted on Flotetuzumab?

"Currently, there are 667 live studies for Flotetuzumab with 177 trials in the final stage. While most of these investigations take place in Mishawaka, Indiana, 19 475 facilities around the world are conducting clinical research involving this drug."

Answered by AI
~5 spots leftby May 2026