To Evaluate the Efficacy and Safety of Naxitamab in Patients With Refractory Ewing's Sarcoma (Butterfly)

Sponsor
Anna Raciborska
Study ID
NCT05968768
Phase
PHASE2
Status
Recruiting
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Conditions

  • Ewing Sarcoma

Eligibility Criteria

Sex
ALL
Age
2 Years - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • Naxitamab — DRUG
    Naxitamab will be used only in a hospital setting and must be administered under the supervision of a doctor with experience in the use of oncological therapies. The medicinal product must be administered by a healthcare professional prepared to deal appropriately with severe allergic reactions, including anaphylaxis, in an environment that provides immediate, full access to resuscitation. The patient should have 2 well-functioning IV accesses before any naxitamab treatment is initiated. The solution should be administered through a peripheral or central intravenous catheter. Other concomitant intravenous medicinal products should be administered through separate intravenous access. Before the start of each infusion, premedication will be carried out.

Study Details

Prospective, interventional, open, randomized, national, multicenter, non-commercial trial

Key Dates

First listed
Aug 1, 2023
Start date
Oct 24, 2023
Status verified
Apr 2025
Primary completion
May 1, 2027
Completion
Jul 31, 2028

Study Design

Enrollment
24 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental - Naxitamab Arm
    Treatment with naxitamab will be continued no longer than 6 cycles a year or until disease progression, patient consent, unacceptable toxicities, or study closure
  • No Intervention: Control Group - standard treatment
    The control group - will receive only standard treatment.

Primary Outcome Measure

Safety assessment of the addition of naxitamab to standard 3-week chemotherapy (CHT) in patients with refractory Ewing's sarcoma (ES) [ Time Frame: up to 240 days ]

Central Contacts

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