Hu8F4 in Treating Patients With Advanced Hematologic Malignancies
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|ClinicalTrials.gov Identifier: NCT02530034|
Recruitment Status : Recruiting
First Posted : August 20, 2015
Last Update Posted : September 19, 2019
|Condition or disease||Intervention/treatment||Phase|
|Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive High Risk Myelodysplastic Syndrome HLA-A2 Positive Cells Present Myelodysplastic Syndrome With Excess Blasts-1 Myelodysplastic Syndrome With Excess Blasts-2 Myelofibrosis Previously Treated Myelodysplastic Syndrome Recurrent Acute Myeloid Leukemia Recurrent Chronic Myelomonocytic Leukemia Refractory Chronic Myelomonocytic Leukemia Secondary Acute Myeloid Leukemia||Drug: Anti-PR1/HLA-A2 Monoclonal Antibody Hu8F4 Other: Laboratory Biomarker Analysis Other: Pharmacological Study||Phase 1|
I. To determine the dose limiting toxicity (DLT) and maximum tolerated dose (MTD) of Hu8F4 when administered intravenously in patients with leukemia or myelodysplastic syndrome (MDS).
II. To determine the pharmacokinetics (PK) of Hu8F4 following study drug administration.
I. To observe the anti-leukemia effects of Hu8F4 in patients with leukemias and MDS.
II. To measure the overall survival, disease-free survival and event-free survival of patients with leukemias or MDS treated with Hu8F4.
OUTLINE: This is a dose-escalation study.
Patients receive anti-PR1/HLA-A2 monoclonal antibody Hu8F4 intravenously (IV) over 60 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Study of Hu8F4 in Patients With Advanced Hematologic Malignancies|
|Actual Study Start Date :||January 31, 2019|
|Estimated Primary Completion Date :||January 31, 2022|
|Estimated Study Completion Date :||January 31, 2022|
Experimental: Treatment (Hu8F4)
Patients receive anti-PR1/HLA-A2 monoclonal antibody Hu8F4 IV over 60 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Drug: Anti-PR1/HLA-A2 Monoclonal Antibody Hu8F4
Other Name: Hu8F4
Other: Laboratory Biomarker Analysis
Other: Pharmacological Study
- (MTD) of Hu8F4 when administered intravenously in patients with leukemia or myelodysplastic syndrome (MDS). [ Time Frame: 4 weeks ]The highest dose level at which </=1 patient experiences dose limiting toxicity (DLT) will be defined as the MTD and will be selected as the recommended phase 2 dose. DLT is defined as any clinically significant non-hematologic adverse event or abnormal laboratory value occurring during the first cycle on study that is not related to disease, comorbidities or concomitant medications.
- Overall survival [ Time Frame: Up to 4 years ]Estimated using the Kaplan-Meier methods.
- Disease-free survival [ Time Frame: Up to 4 years ]Estimated using the Kaplan-Meier methods.
- Event-free survival [ Time Frame: Up to 4 years ]Estimated using the Kaplan-Meier methods.
- Duration of complete remission [ Time Frame: Up to 4 years ]Complete remission rates will be estimated along with 95% credible intervals. Estimated using the Kaplan-Meier methods.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02530034
|Contact: Jorge Cortesemail@example.com|
|United States, Texas|
|M D Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Jorge E. Cortes 713-794-5783|
|Principal Investigator: Jorge E. Cortes|
|Principal Investigator:||Jorge Cortes||M.D. Anderson Cancer Center|