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Recombinant Erwinia Asparaginase and Venetoclax with Blinatumomab for Relapsed/Refractory B-cell ALL

This study is testing a combination of three medicines for people aged 12 to 55 with B-cell acute lymphoblastic leukemia (ALL) that has come back or hasn't responded to previous treatments. The medicines are recombinant Erwinia asparaginase, venetoclax, and blinatumomab. Researchers want to find out if this combination is safe, what side effects it might cause, and how well it works to treat the leukemia. This study is looking for about 26 participants. Success will be measured by how many people experience a complete or partial remission of their leukemia.

Study design
This is an interventional study, meaning participants will receive specific treatments. It is a Phase I/Ib study, which means it's primarily focused on safety and finding the best dose, but also looks at how well the treatment works.
What's involved
You would receive recombinant Erwinia asparaginase injections, blinatumomab through an IV, and undergo blood draws and bone marrow aspirations and biopsies.
Compensation
Not stated in the trial record.
Follow-up
The study will track adverse events (side effects) for up to 30 days after your last dose of treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07133997

Recombinant Erwinia Asparaginase and Venetoclax in Combination With Blinatumomab for the Treatment of Relapsed or Refractory CD19 Positive B-cell Acute Lymphoblastic Leukemia

Recruiting
PHASE1Ages 12–55InterventionalTreatment
City of Hope Medical Center
~26 participants
Updated 2026-07-14 on ClinicalTrials.gov
What's tested:Asparaginase Erwinia chrysanthemiBiospecimen CollectionBlinatumomabBone Marrow AspirationBone Marrow BiopsyCyclophosphamide

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of adverse events (AEs) (Phase I)
Measured over Up to 30 days after last dose of study treatment
+4 more outcomes measured

Conditions

Recurrent B Acute Lymphoblastic Leukemia
Refractory B Acute Lymphoblastic Leukemia

Explore related trials

B Acute Lymphoblastic LeukemiaCD19 Gene

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Amandeep Salhotra · PRINCIPAL_INVESTIGATOR · City of Hope Medical Center

Who to contact

Amandeep Salhotra
[email protected]
626-218-2405
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Documented informed consent of the participant and/or legally authorized representative
Age between 12 and 55
Eastern Cooperative Oncology Group (ECOG) ≤ 2 or Karnofsky performance status (KPS) ≥ 70
Patients with relapsed or refractory (R/R) CD19 positive (+) B-cell acute lymphoblastic leukemia (B-ALL) according to World Health Organization (WHO) criteria
Greater than or equal to 5% blasts in the bone marrow
White blood cell count less than 25 x 10\^9/L prior to initiation of venetoclax. (within 14 days prior to day 1 of protocol therapy) Cytoreduction with hydroxyurea, steroid or a single dose of cyclophosphamide chemotherapy prior to treatment may be required
Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (within 14 days prior to day 1 of protocol therapy) (unless has Gilbert's disease or underlying leukemia, ≤ 3 x ULN)
Prothrombin time (PT) ≤ 1.5 ULN (within 14 days prior to day 1 of protocol therapy)
Partial thromboplastin time (PTT) ≤ 1.5 ULN (within 14 days prior to day 1 of protocol therapy)
Aspartate aminotransferase (AST) ≤ 2.5 x ULN (within 14 days prior to day 1 of protocol therapy) (Unless it is related to underlying leukemia, then AST ≤ 5 x ULN)
Alanine aminotransferase (ALT) ≤ 2.5 x ULN (within 14 days prior to day 1 of protocol therapy) (Unless it is related to underlying leukemia, then ALT ≤ 5 x ULN)
Creatinine clearance of ≥ 60 mL/min per 24 hour urine test or the Cockcroft-Gault formula (within 14 days prior to day 1 of protocol therapy)
Left ventricular ejection fraction (LVEF) ≥ 50% (within 14 days prior to day 1 of protocol therapy)
Note: Echocardiogram to be performed within 42 days prior to day 1 of protocol therapy
Women of childbearing potential (WOCBP): Negative urine or serum pregnancy test (within 14 days prior to day 1 of protocol therapy)
If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 3 months after the last dose of protocol therapy
Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \> 1 year (women only).

Exclusion

Allogeneic hematopoietic cell transplantation (HCT) within 8 weeks prior to the start of protocol-specific therapy. Subjects must be off all immunosuppression for ≥ 2 weeks
Cancer chemotherapy within 2 weeks before the start of protocol-specified therapy with the exception of: intrathecal chemotherapy and/or low-dose maintenance therapy (e.g. vina alkaloids, mercaptopurine, methotrexate, or hydroxyurea etc)
Strong and moderate CYP3A4 inducers and strong CYP3A inhibitors within 7 days prior to day 1 of protocol therapy
Foods/supplements that are strong inhibitors or strong or moderate inducers of CYP3A (such as grapefruit, Seville oranges, starfruit and St. John's wort) within 3 days prior to initiation of and during study treatment
Immunotherapy (e.g. rituximab) within 4 weeks before the start of protocol-specified therapy. Prior failed CD19-directed therapy such as prior blinatumomab or CD19-directed chimeric antigen receptor (CAR)-T cells will be allowed if treatment ended \> 4 weeks prior to start of protocol-specific therapy and there is demonstrated continued CD19+ expression
Must not have received or planning to receive live vaccine while being on study or 2 weeks before and after completion of treatment
Patients with any prior intolerance leading to discontinuation of pegylated (PEG)-asparaginase due to grade 3 or more pancreatitis or central nervous system thrombosis requiring anticoagulant treatment attributed to the PEG-asparaginase
Active ALL in the central nervous system (CNS): Presence of \> 5 white blood cells (WBC) per cubic millimeter in the cerebrospinal fluid (CSF) with lymphoblasts present (confirmed by CSF analysis) and/or clinical signs of CNS leukemia. If CSF leukemia is present, subjects will need to receive intrathecal chemotherapy and have documented negative CSF prior to enrollment
Active acute or chronic graft versus host disease requiring systemic treatment with immunosuppressive medication
History of intracranial thrombosis or history of recurrent thrombosis or grade 3 and greater pulmonary embolism (except for catheter-related thrombosis)
Participants with history of grade ≥ 3 pancreatitis
History of alcohol overuse if deemed relevant in investigator's opinion
Known hypersensitivity to blinatumomab/ recombinant Erwinia asparaginase or to any component of the product formulation, otherwise prior treatment with single agent blinatumomab is allowed
Uncontrolled active infection
Clinically significant uncontrolled illness or cirrhosis
Other active malignancy (except superficial skin cancers squamous cell carcinoma \[SCC\]/basal cell carcinoma \[BCC\], early-stage malignancies ductal carcinoma in-situ \[DCIS\] status post \[s/p\] excision or elevated prostate specific antigen \[PSA\])
Females only: Pregnant or breastfeeding
Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures
Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)

What this trial measures

  • Incidence of adverse events (AEs) (Phase I)Up to 30 days after last dose of study treatment

    Will be graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0. Will be summarized in terms of type (organ affected or laboratory determination), severity, attribution, time of onset, duration, probable association with the study treatment and reversibility or outcome by counts/ rates and 95% Clopper Pearson confidence interval (CI).

  • Dose-limiting toxicities (DLT) (Phase I)From the start of therapy (day 1) through the end of the first cycle (day 49)

    Will be graded according to NCI CTCAE v 5.0. Will be summarized in terms of type (organ affected or laboratory determination), severity, attribution, time of onset, duration, probable association with the study treatment and reversibility or outcome by counts/ rates and 95% Clopper Pearson CI.

  • Maximum tolerated schedule (Phase I)During cycle 1 (cycle length = 49 days)

    Will be based on the assessment of DLT during cycle 1.

  • Recommended phase 2 schedule (Phase 1)After cycle 1 (cycle length = 49 days)

    Will be selected based on maximum tolerated schedule and a review of cumulative toxicity and tolerability data after cycle 1 and may be lower than the maximum tolerated schedule.

  • Best response (Expansion Phase)Up to 30 days after last dose of study treatment

    The 95% Clopper Pearson binomial CI will be calculated.