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RECRUITING
NCT07133997
PHASE1

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

Sponsor: City of Hope Medical Center

View on ClinicalTrials.gov

Summary

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.

Official title: A Phase 1/1b Study Evaluating Asparaginase Erwinia Chrysanthemi- Recombinant-Rywn (Recombinant Erwinia Asparaginase) and Venetoclax in Combination With Blinatumomab in Adults With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia

Key Details

Gender

All

Age Range

12 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

26

Start Date

2026-06-01

Completion Date

2028-06-01

Last Updated

2026-04-07

Healthy Volunteers

No

Interventions

DRUG

Asparaginase Erwinia chrysanthemi

Given IM

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

BIOLOGICAL

Blinatumomab

Given CIV

PROCEDURE

Bone Marrow Aspiration

Undergo bone marrow aspiration and biopsy

PROCEDURE

Bone Marrow Biopsy

Undergo bone marrow aspiration and biopsy

DRUG

Cyclophosphamide

Given cyclophosphamide

PROCEDURE

Echocardiography Test

Undergo ECHO

PROCEDURE

Lumbar Puncture

Undergo lumbar puncture

PROCEDURE

Multigated Acquisition Scan

Undergo MUGA

DRUG

Venetoclax

Given PO

DRUG

Vincristine

Given vincristine

Locations (1)

City of Hope Medical Center

Duarte, California, United States