The researchers are doing this study to see if alectinib in combination with duvelisib is a safe and effective time-limited treatment for people with relapsed or refractory ALK+ anaplastic large cell lymphoma (ALCL). The researchers will test different doses of the study drugs to find the highest doses that cause few or mild side effects in participants. Once they find this dose combination, they will test it in a new group of participants to learn how long the effect of the combination lasts after the end of treatment
Pathologically-confirmed diagnosis of ALK+ ALCL by WHO/ICC, classification procedures in use at the time of diagnosis. Note that ALK+ ALCL by definition expresses ALK, which is readily detectable on standard IHC. Confirmation through molecular sequencing of the specific ALK translocation and fusion partner is not necessary for enrollment.
Relapsed or refractory disease after at least one line of prior systemic therapy.
NOTE: Prior systemic therapy must have included at least one cytotoxic chemotherapy agent.
NOTE: Prior treatment with an ALK inhibitor is allowed.
Prior allogeneic stem cell transplant within 6 months of starting treatment or patients with active graft versus host disease (GVHD).
Previous systemic anti-cancer therapy for ALK+ ALCL within 7 days of initiating study drug
NOTE: Systemic corticosteroids are allowed and must be tapered to 10 mg/day or less (prednisone equivalent) upon start of investigational treatment.
NOTE: Patients who have received localized radiotherapy as part of immediate prior therapy may be allowed to enroll with shorter washout period after discussion with the MSK Principal Investigator.
Sequential
Alectinib
DrugAll patients will receive a lead-in cycle (28 days) of alectinib.
Duvelisib
DrugAfter the lead-in cycle of alectinib, in the absence of progressive disease as assessed by PET/CT scan, all patients will then receive two 28-day cycles of alectinib plus duvelisib.
Determine the maximum tolerated dose (MTD)
of alectinib (A) + duvelisib (D) The MTD will be defined as the dose level at which the estimated dose-limiting toxicity (DLT) rate from the CRM model is closest to the target acceptable rate of 25%.
1-year relapse-free rate
in patients who achieve CR and stop treatment For PET/CT scan, a five-point scale for visually assessing response, referred to as the Deauville criteria, was developed by international experts in the field and will be utilized for grading of PET/CT response. The Lugano criteria will be applied to define complete response (CR), partial response (PR), stable disease (SD), and progression of disease (PD).
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Memorial Sloan Kettering Cancer Center
Lead sponsor
Genentech, Inc.
Collaborator
Secura Bio, Inc.
Collaborator
