Actively Recruiting
A Study of Alectinib and Duvelisib in People With Anaplastic Lymphoma Kinase-Positive Anaplastic Large Cell Lymphoma (ALK+ALCL)
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-04-08
30
Participants Needed
7
Research Sites
313 weeks
Total Duration
On this page
Sponsors
M
Memorial Sloan Kettering Cancer Center
Lead Sponsor
G
Genentech, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
A Study of Alectinib and Duvelisib in People With Anaplastic Lymphoma Kinase-Positive Anaplastic Large Cell Lymphoma (ALK+ALCL)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older at enrollment
- Pathologically confirmed diagnosis of ALK-positive anaplastic large cell lymphoma (ALK+ ALCL)
- Relapsed or refractory disease after at least one prior systemic therapy including chemotherapy
- Prior treatment with an ALK inhibitor is allowed
- Patients on ALK inhibitors in remission are eligible if not planned for immediate transplant
- ECOG performance status of 2 or less at enrollment
- Laboratory criteria met including specific neutrophil, platelet counts, creatinine clearance, and liver function levels
- Able to swallow pills
- Able to take prophylactic medication against Pneumocystis jirovecii pneumonia
- Negative pregnancy test within 14 days for women of reproductive potential
- Use of effective contraception during treatment and specified periods after last dose for males and females
You will not qualify if you...
- Prior allogeneic stem cell transplant within 6 months or active graft versus host disease
- Systemic anti-cancer therapy for ALK+ ALCL within 7 days prior to study drug start (some exceptions apply)
- Use of immunosuppressants including corticosteroids >10 mg prednisone equivalent at enrollment
- Gastrointestinal conditions or surgeries affecting drug absorption
- Active hepatitis B or C infection not controlled by treatment
- HIV infection without compliant antiretroviral therapy
- Concurrent malignancy requiring active treatment in past 2 years (with some exceptions)
- Active cytomegalovirus infection requiring therapy
- Use of CYP4503A inhibitors or inducers at treatment start
- Pregnant or breastfeeding women
- Serious or unstable medical, laboratory, or psychiatric conditions preventing informed consent or increasing risk
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 7 locations
1
Memorial Sloan Kettering Basking Ridge (LimitedProtocol Activities)
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
2
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, United States, 07748
Actively Recruiting
3
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States, 07645
Actively Recruiting
4
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
Commack, New York, United States, 11725
Actively Recruiting
5
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, United States, 10604
Actively Recruiting
6
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States, 10065
Actively Recruiting
7
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, United States, 11553
Actively Recruiting
Research Team
R
Robert Stuver, MD
CONTACT
S
Steven Horwitz, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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