CURE's Clinical Trial Corner: December 2019

January 1, 2020
Kristie L. Kahl

Here is a list of the recent trial initiations that occurred within the cancer space in December.

As the cancer treatment landscape continues to grow, patients and their caregivers should be aware of the various clinical trials currently being conducted — and ones they can possibly join.

Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma

The first patient has been enrolled in the pivotal phase 2/3 clinical study for JZP-458, which is being conducted in collaboration with the Children's Oncology Group (COG). The single-arm, open-label, multicenter, dose confirmation and confirmatory trial is designed to evaluate the safety, tolerability and efficacy of JZP-458 as a potential treatment for pediatric and adult patients with acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LBL) who are hypersensitive to E. coli-derived asparaginases.

This study is expected to enroll patients in approximately 60 COG institutions in the U.S. and Canada.

RET-Mutant Medullary Thyroid Cancer

Eli Lilly and Company have launched the randomized phase 3 LIBRETTO-531 clinical trial — designed to evaluate selpercatinib (LOXO-292) compared with physician’s choice of Cabometyx (cabozantinib) or Caprelsa (vandetanib) for the initial treatment of treatment-naïve patients with RET-mutant medullary thyroid cancer. For patients randomized to the control arm (physician’s choice therapy), crossover is allowed at progression.

The primary endpoints of the study will be progression-free survival (the time from treatment to disease progression or worsening), treatment failure-free survival (the absence of relapse or non-relapse mortality or the addition of another systemic therapy), overall survival, overall response rate and duration of response. The trial will enroll 400 patients with advanced or metastatic RET-mutant medullary thyroid cancer who have received no prior systemic therapy for metastatic disease.

Waldenström’s Macroglobulinemia

X4 Pharmaceuticals, Inc. initiated a phase 1b trial of mavorixafor (X4P-001) in combination with Imbruvica (ibrutinib) for the treatment of Waldenström’s macroglobulinemia, a rare form of non-Hodgkin’s lymphoma. The multicenter, open-label, dose-escalation, clinical trial is designed to assess the safety and tolerability of mavorixafor in combination with Imbruvica in patients with Waldenström’s macroglobulinemia who have acquired a “gain of function” mutation in CXCR4 in addition to the MYD88 mutation.

The clinical trial, which is being conducted as part of a collaboration with The Leukemia & Lymphoma Society, is expected to enroll approximately 12-18 patients.

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