Flotetuzumab for the Treatment of Relapsed or Refractory Advanced CD123-Positive Hematological Ma… (NCT04681105) | Clinical Trial Compass
CompletedPhase 1
Flotetuzumab for the Treatment of Relapsed or Refractory Advanced CD123-Positive Hematological Malignancies
United States13 participantsStarted 2020-11-18
Plain-language 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.
Who can participate
Age range12 Years
SexALL
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Inclusion Criteria:
* Documented informed consent of the participant and/or legally authorized representative
* Assent, when appropriate, will be obtained per institutional guidelines
* Agreement to allow the use of archival tissue from diagnostic tumor biopsies
* If unavailable, exceptions may be granted with study principal investigator (PI) approval
* Eastern Cooperative Oncology Group (ECOG) =\< 2
* Histologically confirmed diagnosis of
* Cohort A. Acute lymphoblastic leukemia
* B-cell phenotype: patients with relapsed or refractory ALL who have received at least 2 prior regimens and failed or are ineligible for CD19-based targeted therapy
* T-cell phenotype: patients with relapsed or refractory who have received at least 1 prior regimen
* Cohort B. Other CD123+ hematological malignancies that failed standard regimens, excluding acute myeloid leukemia and myelodysplastic syndrome
* Blastic plasmacytoid dendritic cell neoplasm (BPDCN) patients who have failed or relapsed after initial therapy
* Chronic myelocytic leukemia (CML) patients who have failed or relapsed or ineligible for third generation tyrosine kinase inhibitor (ponatinib)
* Hairy cell leukemia patients who have failed or progressed shortly after purine analogs or failed 2 cycles of purine analog
* Systemic mastocytosis patients who have failed or progressed on midostaurin
* Hodgkin lymphoma patients who have failed or relapsed after PD-1/PD-L1- inhibitors and brentuxi…