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)

Sponsor
Goethe University
Study ID
NCT05182385
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

  • ALL, Recurrent, Adult

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Blinatumomab — DRUG
    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.
  • Venetoclax — DRUG
    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.

Study Details

This study is designed to determine the feasibility, safety, tolerability and maximum tolerated dose of Venetoclax in combination with Blinatumomab and to evaluate the response in patients treated with the combination of Venetoclax and Blinatumomab in in patients with hematological relapse or molecular relapse.

Key Dates

Start date
Dec 15, 2021
Status verified
Jul 2025
Primary completion
Apr 30, 2026
Completion
Apr 30, 2026

Study Design

Enrollment
30 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: hematological relapse
    Diagnosis of Ph-negative, CD19-positive B-precursor acute lymphoblastic leukemia according to WHO classification: * Refractory BCP-ALL to primary induction therapy, including at least three cycles of standard chemotherapy * Untreated first relapse of BCP-ALL with first remission duration \< 12 months or * Second or greater relapse of BCP-ALL or refractory relapse or * Relapse of BCP-ALL any time after allogeneic HSCT
  • Experimental: molecular relapse
    Diagnosis of Ph-negative, CD19-positive B-precursor acute lymphoblastic leukemia according to WHO classification: -Positivity of MRD marker of immunoglobulin/T-cell receptor gene rearrangements of greater than 0.01% if in first or second remission of BCP-ALL

Primary Outcome Measure

Phase I/ part 1: Maximum tolerated dose (MTD) [ Time Frame: through study part I completion, anticipated after 1 year ]

Related Studies