MRD-guided Treatment in NPM1mut AML Patients (PEMAZA)
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|ClinicalTrials.gov Identifier: NCT03769532|
Recruitment Status : Not yet recruiting
First Posted : December 7, 2018
Last Update Posted : July 17, 2019
|Condition or disease||Intervention/treatment||Phase|
|Acute Myeloid Leukemia||Drug: Pembrolizumab Drug: Azacitidine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||28 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||MRD-guided Treatment With Pembrolizumab and Azacitidine in NPM1mut AML Patients With an Imminent Hematological Relapse|
|Estimated Study Start Date :||August 2019|
|Estimated Primary Completion Date :||August 2021|
|Estimated Study Completion Date :||August 2022|
Experimental: Pembrolizumab + Azacitidine
Pembrolizumab (IMP): 200 mg i.v. (fixed dose) / Azacitidine (SOC): 75 mg/m2 s.c.
maximum duration of treatment: up to 24 weeks
Pembrolizumab (IMP): 200mg i.v. (fixed dose), every 3 weeks (Q3W), 8 doses
Azacitidine (SOC): 75 mg/m2 s.c., day 1-7 every 4 weeks (Q4W), 6 cycles
- Proportion of event-free patients [ Time Frame: after 24 weeks of combination treatment (i.e. after up to 6 cycles of AZA for 7 days every 4 weeks and up to 8 PEM infusions every 3 weeks) ]
- First hematological relapse after start of combined therapy
- Death from any cause
- AML-treatment other than Pembrolizumab and Azacitidine or hypomethylating agents only
- Overall survival (OS) [ Time Frame: through study completion, an average of 1 year ]Overall survival is defined as the number of days between date of first visit (AZA) and date of death from any cause.
- Proportion of event-free patients [ Time Frame: after 12 weeks of combined therapy ]For this endpoint apply the same definitions as for the primary endpoint.
- Treatment-related mortality [ Time Frame: during 24 weeks of combined therapy ]Any death without preceding hematologic relapse is considered to be treatment related.
- Course of MRD-burden measured as quantitative NPM1/Abelson murine leukemia viral oncogene homolog 1 (ABL) ratio [ Time Frame: through study completion, an average of 1 year ]The NPM1/ABL-ratio will be log-transformed with base 10. With the log transformation a near normal distributed variable will be derived to be able to use parametric methods for analysis. Values below limit of detection (LOD) will be substituted by LOD/2 before log-transformation.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03769532
|Contact: Uwe Platzbecker, Prof. Dr.||+49 351 458 ext 2722||Uwe.Platzbecker@medizin.uni-leipzig.de|
|Contact: Antje Schubert, Dr.||+49 351 458 ext 2722||Antje.Schubert@ukdd.de|
|Principal Investigator:||Uwe Platzbecker, Prof. Dr.||Technische Universität Dresden (TUD)|