A Phase II Study of Daratumumab-Hyaluronidase for Chemoth...

Primary Objective:

To evaluate the rate of complete MRD response by flow cytometry after 4 weekly doses of daratumumab-hyaluronidase (Day 29) among patients with MRD positive T-ALL/T-LBL in morphologic complete remission (CR), complete remission with incomplete hematologic recovery (CRi), complete response with partial hematologic count recovery (CRh).

Secondary Objectives:

To evaluate morphologic relapse free survival (RFS).
To evaluate overall survival (OS).
To assess the survival outcomes in patients that undergo allogeneic stem cell transplant after complete MRD response with daratumumab-hyaluronidase.
To assess adverse effects and tolerability of daratumumab-hyaluronidase in T-ALL/T-LBL.
To assess adverse effects of daratumumab-hyaluronidase during Course 1 among all treated patients and by receiving prior allogenic stem cell transplant or not.
To assess adverse effects of combined daratumumab-hyaluronidase and chemotherapy during Course 1A.
To assess adverse effects of daratumumab-hyaluronidase received during Course 2.
To assess MRD status on Day 64 of treatment or upon count recovery for patients that receive chemotherapy in addition to daratumumab-hyaluronidase during Course 1A.
To assess MRD response in patients receiving daratumumab-hyaluronidase after first line chemotherapy compared to patients receiving daratumumab-hyaluronidase after second or later lines of chemotherapy.

Exploratory Objectives:

To determine MRD relapse free survival (RFS) in patients that achieve MRD negative response with daratumumab-hyaluronidase.
To compare the outcomes of patients with MRD relapse ranging 0.01% to < 0.1% to patients with MRD relapse 0.1% by flow cytometry.
To determine the rate of complete molecular MRD response on Day 29 based on Clonal Ig/TCR gene rearrangements using Adaptive clonoSEQ® next generation sequencing and how molecular MRD response correlates with MRD response measured by flow cytometry.
To identify molecular abnormalities that are associated with MRD relapse or morphologic relapse.

Clinical Trial Details