A Study of Alectinib and Duvelisib in People With Anaplastic Lymphoma Kinase-Positive Anaplastic Large Cell Lymphoma (ALK+ALCL) (NCT07001384)
A Phase I Study of Alectinib Plus Duvelisib in Anaplastic Lymphoma Kinase-Positive Anaplastic Large Cell Lymphoma (ALK+ ALCL)
🩺 Plain-English Summary (8th-Grade Level)
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
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (22 items) and avoid the listed exclusions (14 items).
Location: Memorial Sloan Kettering Basking Ridge (LimitedProtocol Activities) — Basking Ridge, New Jersey
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Prior allogeneic stem cell transplant within 6 months of starting treatment or patients with active graft versus host disease (GVHD). o NOTE: Prior allogeneic stem cell transplant may be allowed after discussion with MSK PI if no GVHD or immunosuppression is present at time of enrollment.
- 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.
- NOTE: Prior progression on ALK inhibitor is not specifically exclusionary though should be reviewed with the MSK Principal Investigatory.
- Ongoing use of immunosuppressant medications, including corticosteroids greater than 10 mg of prednisone or equivalent at the time of enrollment.
- Prior gastrointestinal condition or surgery that may, in the investigator's judgment, adversely affect drug absorption.
- Active viral infection with hepatitis B or hepatitis C. For hepatitis B, patients who are seropositive (hepatitis B core Ab positive) are permitted if HBV DNA is negative by PCR. For hepatitis C, patients who are seropositive (hepatitis C Ab positive) are eligible if HCV DNA is negative by PCR and curative therapy has been completed. o NOTE: Patients with HIV infection are permitted to enroll but are required to be on antiretroviral regimens that are in accordance with the current International AIDS Society guidelines on concurrent use with chemotherapy. Use of experimental antiretroviral agents or those containing zidovudine or ritonavir, cobicistat or similar potent CYP3 inhibitors are prohibited. In order to be eligible, patients taking zidovudine or ritonavir, or cobicistat or other CYP3 inhibitors must change to a different regimen 7 days prior to therapy initiation. Subjects must be on HAART for at least 12 weeks prior to therapy.
- Concurrent malignancy requiring active therapy within the last 2 years with the exception of basal cell or squamous cell carcinoma limited to the skin, carcinoma in situ of the cervix, breast or localized prostate cancer. Adjuvant or maintenance therapy to reduce the risk of recurrence or other malignancy is permissible after discussion with the Principal Investigator.
- Active cytomegalovirus (CMV) as defined by positive CMV PCR with clinical manifestations consistent with active CMV infection and requiring therapy. Carriers will be managed as per institutional guidelines.
- Patients should not be on CYP4503A inhibitors or inducers at the time of treatment initiation.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (7 Sites)
- Memorial Sloan Kettering Basking Ridge (LimitedProtocol Activities) — Basking Ridge, New Jersey
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities) — Middletown, New Jersey
- Memorial Sloan Kettering Bergen (Limited Protocol Activities) — Montvale, New Jersey
- Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities) — Commack, New York
- Memorial Sloan Kettering Westchester (Limited Protocol Activities) — Harrison, New York
- Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York, New York
- Memorial Sloan Kettering Nassau (Limited Protocol Activities) — Uniondale, New York
📞 Contact the Study Coordinator
Phone: (646) 608-4308
Email: stuverr@mskcc.org
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
Explore by condition: All Anaplastic Lymphoma Kinase clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.