Phase 1b/2 Study of Carfilzomib in Combination with Induction Chemotherapy in Children with Relapsed or Refractory Acute Lymphoblastic Leukemia

Contact:

NCT Number:

Protocol:

AAAO2351

Study Status:

Active/Enrolling

Population:

Pediatrics

Phase:

I

The purpose of this study is to learn more about the treatment of children and teenagers whose leukemia has come back (has relapsed) or has not gone away after other treatments (is refractory). Participants will receive the study drug, called carfilzomib in combination with standard chemotherapy, that are dexamethasone, daunorubicin , vincristine and PEG-asparaginase (VXLD backbone). The study consist of 4 periods: Screening Period, Treatment Period, End of Study Period, and Long-term Follow-up Period. Participants with stable disease or better response at the end of the Induction Cycle will be offered an optional cycle of Consolidation chemotherapy.

Are you Eligible? (Inclusion Criteria)

  • To be eligible, subjects must have had 1 or more prior therapeutic attempts.
  • Age 21 years or younger at the time of initial ALL diagnosis and age > 1 year at the time of study treatment initiation.
  • Patients must also meet all eligibility criteria as outlined in the study protocol.

Specialty Area(s)

Pediatric: Solid Tumors

Principal Investigator

Profile Headshot
  • Section Head of Oncology, Division of Hematology, Oncology, and Stem Cell Transplant

Trial Location(s)

CUIMC/Herbert Irving Pavilion
161 Fort Washington Avenue
New York, NY 10032