Chemotherapy + Rituximab for Acute Lymphoblastic Leukemia

Recruiting in Palo Alto (17 mi)

Overseen byRyan D. Cassaday

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: University of Washington

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This phase II trial tests how well etoposide, prednisone, vincristine, cyclophosphamide and doxorubicin (DA-EPOCH) with or without rituximab plus recombinant Erwinia asparaginase (JZP458) works in treating patients with newly diagnosed Philadelphia chromosome (Ph) negative B-acute lymphoblastic leukemia (ALL) or T-ALL. Chemotherapy drugs, such as etoposide, vincristine, cyclophosphamide and doxorubicin, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Anti-inflammatory drugs, such as prednisone, lower the body's immune response and are used with other drugs in the treatment of some types of cancer. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. JZP458 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving DA-EPOCH with or without rituximab plus JZP458 may kill more cancer cells in patients with newly diagnosed Ph negative B-ALL or T-ALL.

Eligibility Criteria

This trial is for patients with newly diagnosed Philadelphia chromosome-negative B-acute lymphoblastic leukemia or T-ALL. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and may need to have specific disease characteristics.

Inclusion Criteria

* Adults (age 18 years and older) with newly-diagnosed Ph- B-ALL or T-ALL

* In the opinion of the treating investigator, patients must be an unsuitable candidate for a pediatric-inspired regimen, reasons for which may include (but not be limited to) older age (e.g., ≥ 40 years), practical/logistical barriers to or toxicity concerns from administration of a pediatric-inspired regimen

* Marrow or blood involvement by ALL detectable by multi-parameter flow cytometry (MFC)

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Treatment Details

Interventions

Asparaginase Erwinia chrysanthemi (Enzyme Inhibitor)
Doxorubicin (Anti-tumor antibiotic)
Prednisone (Corticosteroid)
Rituximab (Monoclonal Antibodies)

Trial OverviewThe trial tests DA-EPOCH chemotherapy (etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin) with/without rituximab plus JZP458 in treating Ph negative B-ALL or T-ALL. It aims to see if adding these drugs can better kill cancer cells.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Treatment (DA-EPOCH, rituximab, JZP458)Experimental Treatment13 Interventions

Patients receive etoposide IV, doxorubicin IV and vincristine IV over 96 hours on days 1-4, cyclophosphamide IV over 1 hour on day 5, prednisone PO BID on days 1-5 of each cycle. In addition, CD20 positive patients receive rituximab IV on day 1 or 5 of each cycle. Patients also receive JZP458 IM every 2-3 days on days 7-21 for up to 7 doses. Cycles repeat every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity. Starting on day 6, 7, or 8, patients also receive pegfilgrastim SC once or filgrastim SC QD until ANC \> 2000/uL past nadir. Patients also undergo blood sample collection and bone marrow collection throughout the study. Additionally, patients with extramedullary disease may undergo CT or PET/CT throughout the study.

Doxorubicin is already approved in United States, European Union, Canada, Japan for the following indications:

🇺🇸 Approved in United States as Adriamycin for: