This phase I/Ib trial tests the safety and side effects of asparaginase Erwinia chrysanthemi-recombinant-rywn (recombinant Erwinia asparaginase) and venetoclax in combination with blinatumomab and how well the combination works in treating patients with CD19 positive B-cell acute lymphoblastic leukemia (ALL) that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). Asparaginase Erwinia chrysanthemi, a type of protein synthesis inhibitor, is a drug that is made up of the enzyme asparaginase, which comes from the bacterium Erwinia chrysanthemi. It is used in people who cannot take asparaginase that comes from the bacterium E. coli. Asparaginase Erwinia chrysanthemi breaks down the amino acid asparagine and may stop the growth of cancer cells that need asparagine to grow. It may also kill cancer cells. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Blinatumomab is a drug used to treat certain types of B-cell acute lymphoblastic leukemia that are CD19 positive (expresses the protein CD19). Blinatumomab binds to CD19, which is found on most B cells (a type of white blood cell) and some types of leukemia cells. It also binds to a protein called CD3, which is found on T cells (another type of white blood cell). This may help the immune system kill cancer cells. Blinatumomab is a type of bispecific T-cell engager. Giving asparaginase Erwinia chrysanthemi and venetoclax in combination with blinatumomab may be safe, tolerable, and/or effective in treating patients with relapsed or refractory ALL.
PRIMARY OBJECTIVES: I. Evaluate the safety and tolerability of asparaginase Erwinia chrysanthemi- recombinant-rywn (recombinant Erwinia asparaginase) and venetoclax in combination with blinatumomab for the target population by evaluation of toxicities including: type, frequency, severity, attribution, time course and duration. (Phase I) II. Determine the recommended phase 2 schedule (RP2S) of recombinant Erwinia asparaginase and venetoclax in combination with blinatumomab. (Phase I) III. Estimate the anti-tumor efficacy of recombinant Erwinia asparaginase and venetoclax in combination with blinatumomab as assessed by composite remission (including complete remission (CR), CR with partial hematologic recovery (CRh) and CR with incomplete hematologic recover (CRi) rate. (Expansion Phase) SECONDARY OBJECTIVES: I. Evaluate the safety of recombinant Erwinia asparaginase in combination with blinatumomab and venetoclax at expansion phase. II. Estimate minimal residual disease (MRD) negativity (-) rate at the end of each cycle (by flow MRD and Clonoseq). III. Among transplant eligible patients, determine the number and proportion of patients who bridge directly from trial therapy to allogeneic hematopoietic stem cell transplant (alloHSCT). EXPLORATORY OBJECTIVES: I. Explore BH3 profiling on pretreatment bone marrow aspirate to predict response to blinatumomab with recombinant Erwinia asparaginase and venetoclax. II. Explore role of somatic mutations in pretreatment bone marrow biopsy to predict response to blinatumomab with recombinant Erwinia asparaginase and venetoclax. III. Examine changes in cell composition-both leukemic and non-leukemic-before and after treatment. IV. Estimate the proportion of patients maintaining adequate nadir serum asparaginase activity (≥ 0.1 IU/mL) at 48 hours post last dose of recombinant Erwinia asparaginase. V. Immune profiling of ALL blasts. OUTLINE: PRE-PHASE TREATMENT/BRIDGE THERAPY: Starting days -7 to -5, patients may optionally receive cyclophosphamide and vincristine on day 1 and prednisone on days 1-5. TREATMENT: Patients receive asparaginase Erwinia chrysanthemi intramuscularly (IM) on days 1,3, 5, 7, 9, 11, and 13, venetoclax orally (PO) once daily (QD) on days 1-14 or once every other day (QOD) on days 1, 3, 5, 7, 9, 11, and 13 of each cycle and blinatumomab continuous intravenously (CIV) on days 8-35 of cycle 1 and on days 1-28 of cycle 2. Cycles repeat every 49 days for cycle 1 and 42 days for cycle 2 for up to 2 cycles in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo echocardiography (ECHO) and multigated acquisition scan (MUGA) at screening and bone marrow aspiration and biopsy, blood sample collection, and lumbar puncture throughout the study. After completion of study treatment, patients are followed up at 30 days.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
26
Given IM
Undergo blood sample collection
Given CIV
Undergo bone marrow aspiration and biopsy
Undergo bone marrow aspiration and biopsy
Given cyclophosphamide
Undergo ECHO
Undergo lumbar puncture
Undergo MUGA
Given PO
Given vincristine
City of Hope Medical Center
Duarte, California, United States
Incidence of adverse events (AEs) (Phase I)
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).
Time frame: Up to 30 days after last dose of study treatment
Dose-limiting toxicities (DLT) (Phase I)
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.
Time frame: From the start of therapy (day 1) through the end of the first cycle (day 49)
Maximum tolerated schedule (Phase I)
Will be based on the assessment of DLT during cycle 1.
Time frame: During cycle 1 (cycle length = 49 days)
Recommended phase 2 schedule (Phase 1)
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.
Time frame: After cycle 1 (cycle length = 49 days)
Best response (Expansion Phase)
The 95% Clopper Pearson binomial CI will be calculated.
Time frame: Up to 30 days after last dose of study treatment
Composite remission rate
The complete remission (CR)/CR with incomplete recovery/CR with partial hematologic recovery and 95% Clopper Pearson binomial CI will be calculated.
Time frame: At end of cycle 1 (cycle length = 49 days)
Minimal residual disease negativity
Will be defined as residual leukemia \< 0.01% by flow cytometry or Clonoseq in bone marrow biopsy. Clopper Pearson binomial CI will be calculated.
Time frame: At the end of each cycle (cycle 1 length = 49 days, cycle 2 length = 42 days)
Incidence of adverse events (Expansion Phase)
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.
Time frame: Up to 30 days after last dose of study treatment
Patients who bridge to transplant directly from the trial therapy
The Clopper Pearson binomial CI will be calculated.
Time frame: Up to 30 days after last dose of study treatment
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