TG Therapeutics UTX-IB-301

A phase 3, randomized, study to assess the efficacy and safety of ublituximab in combination with ibrutinib compared to ibrutinib alone, in patients with previously treated high-risk chronic lymphocytic leukemia (CLL).

NCT02301156

Leukemia, CLL, Chronic lymphocytic leukemia, SLL, small lymphocytic lymphoma

N/A

Relapsed/refractory

>2nd line

Ublituximab

3rd gen anti-CD20 monoclonal antibody

Jason Chandler, MD

TG Therapeutics

Phase 3

Closed to Accrual

https://www.clinicaltrials.gov/ct2/show/NCT02301156

Previously treated ( at least 2 cycles)CLL/SLL
One or more high-risk cytogenetic features (del 17p, del 11q, p53 mutation)
Has at least one of following clinical criteria:
1.Progressive marrow failure (anemia or thrombocytopenia)
2.Massive, progressive, or symptomatic splenomegaly
3.Massive, progressive, or symptomatic lymphadenopathy
4.Progressive lymphocytosis as follows:
Either increase in ALC>50% over 2 months
or lymphocyte doubling time 30K)
5.Autoimmune anemia or thrombocytopenia
6.B-symptoms or unintentional weight loss
At least1 nodal lesion measuring>2 by>1 cm

ECOG PS 0-2
No prior allo HCT. Auto HCT only if at least 3 months prior.
No prior ibrutinib or other BTK inhibitor

Primary- ORR, PFS; Secondary- CR rate, MRD negativity, safety

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Either:17p deletion11q deletionand/or p53 mutation

Ublituximab- IV d1, d8, d15, then q28 days x 5 months, then q3months

Ibrutinib 420mg PO daily

Yes