Venetoclax in Addition to Blinatumomab in Adult Patients With Relapsed/Refractory B Cell Precursor Acute Lymphoblastic Leukemia Relapsed/Refractory B Cell Precursor Acute Lymphoblastic Leukemia (BCP-ALL)

PHASE1/PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

December 15, 2021

Primary Completion Date

April 30, 2026

Study Completion Date

April 30, 2026

Conditions
ALL, Recurrent, Adult
Interventions
DRUG

Blinatumomab

"All patients with hematological relapse will additionally receive Blinatumomab immunotherapy (first cycle: 9 ug/d c.i.v. on d1 until d7 and 28 ug/d c.iv. on d8 until d28; second cycle: 28 ug/d c.iv. on d1 to d28) in six-week cycles (4 weeks on Blinatumomab, 2 weeks off Blinatumomab).~All patients with molecular relapse will additionally receive Blinatumomab immunotherapy at 28 ug/d c.iv. on d1 until d28 in six-week cycles (4 weeks on Blinatumomab, 2 weeks off Blinatumomab.)~Patients eligible for a second cycle shall not receive Blinatumomab starting dose independent from relapse type."

DRUG

Venetoclax

"In phase I of the study all eligible patients will receive increasing doses of Venetoclax on days -7 to -1 (Venetoclax dose-titration) in the first cycle and continuous dosing of Venetoclax at a pre-specified target dose (TD, p.o., once daily, d1 to d42) in six-week cycles for a maximum of two cycles.~In phase II of the study all eligible patients will receive the recommended phase 2 dose (RP2D) of Venetoclax in six-week cycles for a maximum of two cycles. RP2D will be MTD.~Patients eligible for a second cycle shall not receive Venetoclax dose-titration independent from relapse type."

Trial Locations (17)

12203

Charité - Campus Benjamin Franklin, Berlin

20246

Universitätsklinikum Hamburg-Eppendorf, Hamburg

26133

Klinikum Oldenburg, Oldenburg

40225

University Hospital Düsseldorf, Düsseldorf

50937

Universitätsklinikum Köln, Cologne

60590

University Hospital of Frankfurt (Main), Frankfurt am Main

69120

Universitätsklinikum Heidelberg, Heidelberg

72076

Universitätsklinikum Tübingen, Tübingen

81675

Klinikum Rechts der Isar der TU München, München

89081

Universitätsklinikum Ulm, Ulm

01307

Universitätsklinikum Dresden, Dresden

Unknown

Universität Erlangen, Erlangen

Universitätsklinikum Essen, Essen

UKSH-Kiel, Kiel

Universitätsklinik Leipzig, Leipzig

Klinikum Mannheim, Mannheim

Robert - Bosch - Krankenhaus, Stuttgart

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

University Hospital Schleswig-Holstein

OTHER

lead

Goethe University

OTHER