Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||12 Years and Over|
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|City of Hope Medical Center|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Ibrahim T Aldoss|
|Principal Investigator Affiliation||City of Hope Medical Center|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|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|
Experimental: Treatment (flotetuzumab)
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.
Drug: - Acetaminophen
Drug: - Dexamethasone
Drug: - Diphenhydramine
Given IV or PO
Biological: - Flotetuzumab
Drug: - Ibuprofen
Drug: - Ranitidine
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.