AALL2121: SNDX-5613 for Relapsed or Refractory Leukemia

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This study enrolls patients that have been diagnosed with acute leukemia associated with a KMT2A (MLL) gene rearrangement (referred to as KMT2Arearranged, or KMT2A-R). The KMT2A-R leukemia has come back after treatment (relapsed) or is not responding to treatment (it is refractory). This study involves taking a study drug called SNDX-5613. The study is divided into two phases: one in which the study drug is given in combination with chemotherapy and a phase where the study drug is given alone. The purpose of the study is to test the safety of the study drug with chemotherapy, and how well the treatment regimen works for infants and young children with relapsed or refractory KMT2A-R leukemia.

Who Do I Contact?

If you are interested in participating in the study or want to learn more please contact our study team at cancertrials [at] chop.edu or 267-425-5544.

ClinicalTrials.gov Identifier

NCT05761171

View full trial information on ClinicalTrials.gov

Eligibility & Criteria

IRB #:
23-021761
Official Title:
AALL2121: A Study of SNDX-5613 in Combination with Chemotherapy for Patients Diagnosed with Relapsed or Refractory Leukemia
Study Phase:
Phase II
Eligible Age Range:
1 Month - 5 Years
Gender:
All
Study Categories:

Visit Criteria

As a participant in the research, you will:

  • Depending on which phase you enroll into, you will either receive a study drug called SNDX-5613 OR receive a study drug called SNDX-5613 in addition to chemotherapy you would receive as part of your regular cancer care
  • Complete frequent clinic visits at CHOP
  • Have a bone marrow evaluation
  • Have frequent blood tests
  • Have extra or leftover bone marrow collected if you have bone marrow samples collected as part of your regular cancer care
  • Complete medication diaries
  • Have periodic electrocardiograms (ECGs) and echocardiograms (ECHOs) as part of your regular cancer care
  • Have periodic imaging performed as part of your regular cancer care to evaluate your response to treatment
Leader
Kathrin M. Bernt

Kathrin M. Bernt, MD