Flotetuzumab in Treating Patients With Recurrent or Refractory CD123 Positive Blood Cancer (NCT03739606) | Clinical Trial Compass
WithdrawnPhase 2
Flotetuzumab in Treating Patients With Recurrent or Refractory CD123 Positive Blood Cancer
Stopped: RSS recommendation
0Started 2020-10-20
Plain-language summary
This phase II trial studies how well flotetuzumab works in treating patients with CD123 positive blood cancer that has come back or does not respond to treatment. Immunotherapy with monoclonal antibodies, such as flotetuzumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
Who can participate
Age range15 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 target 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 myeloid 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 brentuximab…
What they're measuring
1
Best response of complete remission (complete remission [CR], complete remission with incomplete count recovery [CRi], complete remission with partial hematological recovery [CRh])