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.
Memorial Sloan Kettering Cancer Center
Lead sponsor
Genentech, Inc.
Collaborator
Secura Bio, Inc.
Collaborator