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An open label, phase I/II study of Venetoclax in addition to Blinatumomab immunotherapy in adult patients with relapsed/refractory B cell precursor acute lymphoblastic leukemia (BCP-ALL)
EU CTIS ID: 2024-517959-12-00
What this study is testing
Phase I: determination of feasibility, safety and tolerability and maximum tolerated dose of Venetoclax in combination with Blinatumomab. Phase II: to evaluate the response in patients treated with the combination of Venetoclax and Blinatumomab
- Phase I and Phase II (Integrated)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Written informed consent in accordance with federal, local, and institutional guidelines. The patient must provide informed consent prior to the first screening procedure
- Age ≥ 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
- Availability of patient-specific molecular MRD markers of immunoglobulin/T-cell receptor gene rearrangements as assessed with a sensitivity of at least 10E-04
- 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 or
- 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
You likely can't join if
- Patients with diagnosis of Philadelphia positive BCP-ALL according to WHO classification
- Treatment with any of the following within 7 days prior to the first dose of study drug: strong cytochrome P450 3A (CYP3A) inhibitors, moderate or strong CYP3A inducers
- Patients with diagnosis of Burkitt´s Leukemia according to WHO classification
- Patients with extramedullary relapse; non-bulky lymph node (< 7.5 cm diameter) involvement will be accepted
- Patients with CNS involvement at relapse (as determined by CSF analysis)
- Patients with suspected or histologically confirmed testicular involvement at relapse
See the full eligibility criteria
Who can join
- Written informed consent in accordance with federal, local, and institutional guidelines. The patient must provide informed consent prior to the first screening procedure
- Age ≥ 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
- Availability of patient-specific molecular MRD markers of immunoglobulin/T-cell receptor gene rearrangements as assessed with a sensitivity of at least 10E-04
- 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 or
- 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
- Negative pregnancy test < 7 days before first study drug in women of childbearing potential, defined as all women physiologically capable of becoming pregnant, unless they fulfil at least one of the following criteria: − Post-menopausal (i.e. 12 months of natural amenorrhea or 6 months of amenorrhea with Serum FSH > 40 U/ml − Post-operative after bilateral ovariectomy with or without hysterectomy − Continuous and correct application of a contraception method with a Pearl index of < 1% (e.g. implants, depots, oral contraceptives, intrauterine device) from initial study drug administration until at least 3 months after the last dose of study drug. A hormonal contraception method must always be combined with a barrier method (e.g. condom) − Sexual abstinence − Vasectomy of the sexual partner
- Ability to understand and willingness to sign a written informed consent
- Willingness to participate in the registry of the German Multicenter Study Group for Adult ALL (GMALL)
What rules you out
- Patients with diagnosis of Philadelphia positive BCP-ALL according to WHO classification
- Treatment with any of the following within 7 days prior to the first dose of study drug: strong cytochrome P450 3A (CYP3A) inhibitors, moderate or strong CYP3A inducers
- Patients with diagnosis of Burkitt´s Leukemia according to WHO classification
- Patients with extramedullary relapse; non-bulky lymph node (< 7.5 cm diameter) involvement will be accepted
- Patients with CNS involvement at relapse (as determined by CSF analysis)
- Patients with suspected or histologically confirmed testicular involvement at relapse
- Current autoimmune disease of any kind or history of autoimmune disease with potential CNS involvement
- Patients with Philadelphia-positive BCP-ALL still receiving TKI
- Prior or concomitant therapy with BH3 mimetics
- Prior therapy with anti CD19 therapy, unless administered in MRD-positive setting (i.e. with bone marrow blasts ≤ 5%)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.