642. CLL: Therapy, excluding Transplantation: Targeting MRD Negative CLL with Combinations of Novel Agents and Chemoimmunotherapy Regimens, New Treatments

493

Results from the Phase 3 DUOTM Trial: A Randomized Comparison of Duvelisib Vs Ofatumumab in Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Ian W. Flinn, et al.

The authors of the study conclude:

The final unblinded efficacy and safety analyses will be presented at the 59^th Annual American Society of Hematology Meeting in December, and include the primary and key secondary endpoints of PFS, ORR, and OS and safety for both treatment arms, including the rates of adverse events (AEs), severe AEs, and AEs leading to treatment discontinuation. Clinical trial information: NCT02004522.

494

Bendamustine Followed By Ofatumumab and Ibrutinib in Patients with Chronic Lymphocytic Leukemia (CLL): CLL2-BIO Trial of the German CLL Study Group (GCLLSG)

Paula Cramer, et al.

The authors of the study conclude:

This sequential treatment of bendamustine debulking, followed by ofatumumab and ibrutinib was well tolerated without unexpected safety signals and showed a good efficacy with an ORR of 93%. Ongoing maintenance treatment aims at deeper responses with MRD negativity.

495

Ibrutinib, Fludarabine, Cyclophosphamide, and Obinutuzumab (GA101) (iFCG) for First-Line Treatment of Patients with CLL with Mutated IGHV and without TP53 Aberrations

Nitin Jain, MD1, et al.

The authors of the study conclude:

 iFCG achieves high rate of undetectable MRD after 3 courses. All 12 pts who have reached the 1 year time point are MRD-negative and have stopped all therapy including ibrutinib. Enrollment, treatment and follow up continues.

496

A Multicenter, Phase II Study of Ibrutinib Plus FCR (iFCR) As Frontline Therapy for Younger CLL Patients

Matthew S. Davids, et al.

The authors of the study conclude:

iFCR induced deep responses in a relatively high risk group of previously untreated young CLL pts, with 57% achieving CR with BM-MRD-neg and 83% achieving BM MRD-neg, significantly higher than the 20% rate seen historically with FCR alone. Low rates of hematologic and infectious toxicities may be due to mandatory growth factor and antimicrobial prophylaxis. Updated results on the ibrutinib discontinuation cohort will be presented.

497

Phase II, Multicenter Trial, Exploring “Chemo-Sparing” Strategy Associating Obinutuzumab+Ibrutinib Followed By a MRD Driven Strategy, in Previously Untreated Symptomatic Medically Fit Chronic Lymphocytic Leukemia Patients (CLL): Preliminary Results of the Induction Phase of the Icll-07 Filo Study

Anne-Sophie Michallet, et al.

The authors of the study conclude:

These preliminary results indicated that this 9 month « chemo-free » induction is associated with a high CR rate (37%) without excess of toxicity. However, the majority of the patients required subsequent immuno-chemotherapy because of detectable BM MRD.

498

Acalabrutinib Monotherapy in Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia: Updated Results from the Phase 1/2 ACE-CL-001 Study

John C. Byrd, et al.

The authors of the study conclude:

In this updated analysis, treatment with acalabrutinib continues to be associated with high response rates and durable remissions in patients with R/R CLL/SLL, including those with high-risk disease. Reported AEs indicated a tolerable safety profile. Treatment with acalabrutinib is being investigated in patients with R/R CLL in 2 ongoing Phase 3 studies, ACE-CL-006 (NCT02477696) and ACE-CL-309 (NCT02970318).