Actively Recruiting
A Phase I Study of Alectinib Plus Duvelisib in Anaplastic Lymphoma Kinase-Positive Anaplastic Large Cell Lymphoma
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-05-26
30
Participants Needed
7
Research Sites
N/A
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
Researchers are evaluating the safety and effectiveness of alectinib combined with duvelisib as a time-limited treatment for people with relapsed or refractory ALK-positive anaplastic large cell lymphoma (ALCL). This phase 1 study aims to find the highest doses of these drugs that cause few or mild side effects. After determining this dose combination, the study will assess how long the treatment's effect lasts in a new group of participants. All participants first receive a 28-day lead-in cycle of alectinib. Following this, a PET/CT scan and safety assessment are performed to check for disease progression. Those without progression continue treatment with two additional 28-day cycles combining alectinib and duvelisib. After these combination cycles, participants undergo a response evaluation. Participants will be involved in scans and safety assessments to monitor disease status and side effects. Researchers will measure the maximum tolerated dose over two years and track relapse-free rates for one year. The study includes laboratory tests, performance status assessments, and monitoring of medication adherence and side effects throughout the treatment period.
CONDITIONS
Brief 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...
- Pathologically confirmed ALK-positive anaplastic large cell lymphoma diagnosis
- Relapsed or refractory disease after at least one prior systemic therapy including chemotherapy
- Age 18 years or older at enrollment
- ECOG performance status of 2 or less
- Adequate laboratory values including neutrophil count, platelet count, creatinine clearance, and liver enzymes
- Able to swallow pills
- Able to take prophylactic medication against Pneumocystis jirovecii pneumonia
- Women of reproductive potential must have a negative pregnancy test within 14 days before starting treatment
- Use of effective contraception during treatment and for specified time after treatment for women and men
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 before study drug start (except allowed corticosteroids and localized radiotherapy)
- Ongoing use of high-dose immunosuppressant medications
- Prior gastrointestinal condition or surgery affecting drug absorption
- Active hepatitis B or C infection not controlled by treatment
- Use of certain antiretroviral drugs incompatible with study drugs
- Concurrent malignancy requiring active therapy in last 2 years except some localized cancers
- Active cytomegalovirus infection requiring treatment
- Use of CYP4503A inhibitors or inducers at treatment start
- Pregnant or breastfeeding women
- Serious or unstable medical or psychiatric conditions increasing study risk or preventing informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 28 days
Participants receive a 28-day lead-in cycle of alectinib.
Duration - Two 28-day cycles
Participants without disease progression after the lead-in cycle receive two 28-day cycles of alectinib plus duvelisib.
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
S
Steven Horwitz, MD
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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