RecruitingPhase IEN originalLeukemia

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

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This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the trial

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.

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • Wiek od 12 do 55 lat
  • Potwierdzona białaczka limfoblastyczna B-komórkowa typu CD19-dodatnia, która powróciła po leczeniu lub nie reaguje na leki
  • Liczba białych krwinek poniżej 25 x 10^9/L przed rozpoczęciem leczenia (może być potrzebna wstępna terapia zmniejszająca liczbę białych krwinek)
  • Dobry ogólny stan zdrowia (skala ECOG ≤ 2 lub Karnofsky ≥ 70)
  • Prawidłowa funkcja wątroby i nerek
  • Prawidłowe parametry krzepnięcia krwi
  • Prawidłowa funkcja serca (LVEF ≥ 50%)
  • Dla kobiet: ujemny test na ciążę

Simplified criteria — AI translation

Trial details

Minimum age
12 Years
Maximum age
55 Years
Last updated (source)
July 14, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (1)

City of Hope Medical Center

Duarte, United States

Trial contact

Amandeep Salhotra

PRINCIPAL_INVESTIGATOR

Contact information from ClinicalTrials.gov. Contact in English.

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/15/2026.

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