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Flotetuzumab for CD123-Positive Hematological Malignancies
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
Media Library
- I have recovered from side effects of cancer treatment, except for hair loss.My Hodgkin lymphoma did not respond to PD-1/PD-L1 inhibitors or brentuximab vedotin.My hairy cell leukemia didn't respond to or got worse after purine analog treatment.I have had or been checked for brain involvement but am currently free of it.My condition has returned or didn't respond to treatment.You are expected to live for at least 4 more weeks.My BPDCN has returned or didn't respond to the first treatment.I haven't had most cancer treatments in the last 2 weeks but some medications are exceptions.I have not had major surgery or serious injury in the last 4 weeks.My white blood cell count is healthy for treatment.I had a stem cell transplant less than 100 days before starting the study drug.My BPDCN has returned or didn't respond to the first treatment.I have advanced acute leukemia that didn't respond to two previous treatments.My blood cancer is CD123+ and has not responded to standard treatments, but it's not AML or MDS.I haven't taken any immunosuppressant drugs, except steroids, in the last 2 weeks.I am not pregnant or breastfeeding.My blood cancer is CD123+ and has not responded to standard treatments, but it's not AML or MDS.I've had a lumbar puncture to check for brain or spinal cord disease due to concerning symptoms.My blood cancer is not responding to standard treatments.I do not have any active, untreated autoimmune disorders except for vitiligo.I have had at least one treatment for my relapsed or refractory T-cell cancer.I am mentally capable of understanding and giving informed consent.My heart is healthy and functions well.I have CML and cannot use or did not respond to the latest treatment.My blood cancer is not responding to standard treatments.I am capable of becoming pregnant or fathering a child.I have had at least one treatment for my relapsed or refractory condition.I have recovered from side effects of cancer treatment, except for hair loss.I currently have an infection that isn't under control.My lung function tests are within normal limits or my oxygen levels are above 90% without assistance.My systemic mastocytosis worsened despite midostaurin treatment.I am capable of having children and have not been surgically sterilized.I haven't had certain immune treatments in the last 28 days, except for blinatumomab which was not in the last 14 days.My tumor tests positive for CD123.I am receiving treatment for another cancer, but hormone therapy is okay.I have serious lung problems.I do not have any uncontrolled serious illnesses.My tumor tests positive for CD123.My lung function tests are within normal limits or my oxygen levels are above 90% without assistance.I have acute lymphoblastic leukemia.My condition has returned or didn't respond to treatment.My hairy cell leukemia didn't respond to or got worse after purine analog treatment.My kidney function test shows a creatinine clearance rate above 50 ml/min.My white blood cell count is healthy for treatment.I had a bone marrow transplant over 100 days ago, with no major complications and I'm not on strong immune-suppressing drugs.I am taking more than 10 mg/day of oral prednisone or its equivalent, excluding inhalers, nasal sprays, or eye drops.My acute leukemia is advanced and has not responded to two previous treatments.I've had a lumbar puncture to check for brain or spinal cord disease due to my symptoms.You agree to let the researchers use tissue samples from a previous biopsy for the study.I have CML and cannot use or did not respond to the latest treatment.My Hodgkin lymphoma did not respond to PD-1/PD-L1 inhibitors or brentuximab vedotin.I am able to get out of my bed or chair and move around.I have acute lymphoblastic leukemia.My cancer can be measured and is at least 1.5 cm on a scan.I have ALL, failed 2 treatments, and can't have CD19 therapy.I can take care of myself and am up and about more than 50% of my waking hours.My systemic mastocytosis worsened despite taking midostaurin.My cancer can be measured and is at least 1.5 cm on a scan.I have ALL, failed 2 treatments, and can't have CD19 therapy.
- Group 1: Treatment (flotetuzumab)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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."
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