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

Part of paid clinical trials in Duarte, California.

Sponsor
City of Hope Medical Center
Study ID
NCT07133997
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Recurrent B Acute Lymphoblastic Leukemia
  • Refractory B Acute Lymphoblastic Leukemia

Eligibility Criteria

Sex
ALL
Age
12 Years - 55 Years
Healthy Volunteers
Not accepted

Interventions

  • Asparaginase Erwinia chrysanthemi — DRUG
    Given IM
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Blinatumomab — BIOLOGICAL
    Given CIV
  • Bone Marrow Aspiration — PROCEDURE
    Undergo bone marrow aspiration and biopsy
  • Bone Marrow Biopsy — PROCEDURE
    Undergo bone marrow aspiration and biopsy
  • Cyclophosphamide — DRUG
    Given cyclophosphamide
  • Echocardiography Test — PROCEDURE
    Undergo ECHO
  • Lumbar Puncture — PROCEDURE
    Undergo lumbar puncture
  • Multigated Acquisition Scan — PROCEDURE
    Undergo MUGA
  • Venetoclax — DRUG
    Given PO
  • Vincristine — DRUG
    Given vincristine

Study Details

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.

Key Dates

Start date
Jun 1, 2026
Status verified
Apr 2026
Primary completion
Jun 1, 2028
Completion
Jun 1, 2028

Study Design

Enrollment
26 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (asparaginase, venetoclax, blinatumomab)
    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 IM on days 1,3, 5, 7, 9, 11, and 13, venetoclax PO QD on days 1-14 or QOD on days 1, 3, 5, 7, 9, 11, and 13 of each cycle and blinatumomab 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 ECHO and MUGA at screening and bone marrow aspiration and biopsy, blood sample collection, and lumbar puncture throughout the study.

Primary Outcome Measure

Incidence of adverse events (AEs) (Phase I) [ Time Frame: Up to 30 days after last dose of study treatment ]

Locations (1)

FacilityCityStateZIPSite coordinators
City of Hope Medical CenterDuarteCalifornia91010
Amandeep Salhotra
[email protected]
626-218-2405
Amandeep Salhotra (PRINCIPAL_INVESTIGATOR)

Find similar trials in Duarte, CA

By research site
City of Hope Medical Center· Duarte, CA

Related Studies