Back to search results

A Study of Alectinib and Duvelisib for ALK+ Anaplastic Large Cell Lymphoma

This study is looking into whether a combination of two drugs, alectinib and duvelisib, can be a safe and effective treatment for people with anaplastic lymphoma kinase-positive anaplastic large cell lymphoma (ALK+ ALCL) that has come back or hasn't responded to previous treatments. All participants will first receive alectinib for 28 days. If their disease hasn't worsened, they will then receive alectinib plus duvelisib for two more 28-day cycles. Researchers want to find the highest doses of these drugs that have few or mild side effects. You may be able to join if you are 18 or older and have a confirmed diagnosis of ALK+ ALCL. The study is currently recruiting participants.

Study design
This is an interventional study with a planned enrollment of 30 participants. It is designed to find the maximum tolerated dose of the drug combination.
What's involved
You will receive alectinib for 28 days, followed by two 28-day cycles of alectinib plus duvelisib if your disease has not progressed.
Compensation
Not stated in the trial record.
Follow-up
The maximum tolerated dose will be measured at 2 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07001384

A Study of Alectinib and Duvelisib in People With Anaplastic Lymphoma Kinase-Positive Anaplastic Large Cell Lymphoma (ALK+ALCL)

Recruiting
PHASE1Ages 18+InterventionalTreatment
Memorial Sloan Kettering Cancer Center
~30 participants
Updated 2026-05-26 on ClinicalTrials.gov
What's tested:AlectinibDuvelisib

At a glance

Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Determine the maximum tolerated dose (MTD)
Measured over 2 years

Conditions

Anaplastic Lymphoma Kinase
Anaplastic Large Cell Lymphoma

Explore related trials

Anaplastic Large Cell Lymphoma

NCT07001384

Where you'd take part

This study runs at 7 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Memorial Sloan Kettering Basking Ridge (LimitedProtocol Activities)

    Basking Ridge, New Jerseystudy coordinator listed

    Recruiting

  • Memorial Sloan Kettering Bergen (Limited Protocol Activities)

    Montvale, New Jerseystudy coordinator listed

    Recruiting

  • Memorial Sloan Kettering Cancer Center (All Protocol Activities)

    New York, New Yorkstudy coordinator listed

    Recruiting

  • Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

    Middletown, New Jerseystudy coordinator listed

    Recruiting

  • Memorial Sloan Kettering Nassau (Limited Protocol Activities)

    Uniondale, New Yorkstudy coordinator listed

    Recruiting

  • Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)

    Commack, New Yorkstudy coordinator listed

    Recruiting

  • Memorial Sloan Kettering Westchester (Limited Protocol Activities)

    Harrison, New Yorkstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Robert Stuver, MD · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer Center

Who to contact

Robert Stuver, MD
[email protected]
646-608-4308
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Want this trial checked against your situation?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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.
NOTE: Patients being treated with an ALK inhibitor immediately prior to enrollment are eligible. This includes patients on an ALK inhibitor who are in clinical remission at the time of enrollment, as long as the patient is not immediately planned for allogeneic transplant.
NOTE: If the last therapy was an ALK inhibitor, the patient must not have stopped the ALK inhibitor and maintained clinical remission (no relapse) with no intervening therapy for ≥ six months.
NOTE: Prior progression on ALK inhibitor is not specifically exclusionary though should be reviewed with the MSK Principal Investigator.
Age ≥ 18 years at the time of enrollment
ECOG performance status ≤ 2 at the time of enrollment.
Laboratory criteria:
Absolute neutrophil count ≥ 1.0 K/mcL or ≥ 0.5 K/mcL if due to lymphoma (NOTE: growth factor is allowed).
Platelet count ≥ 75 K/uL.
Calculated creatinine clearance ≥ 60 mL/min by Cockcroft-Gault.
Total bilirubin ≤ 2x upper limit of normal (ULN) or ≤ 3x ULN if due to hepatobiliary involvement with lymphoma, or ≤ 3x ULN if history of Gilbert's disease.
Aspartate (AST) and alanine (ALT) aminotransferase ≤ 3 x ULN or ≤ 5x ULN if due to hepatobiliary involvement with lymphoma.
NOTE: Patients with AST and/or ALT \> 3x ULN and total bilirubin \> 2x ULN must be reviewed with the MSK Principal Investigator to determine eligibility.
NOTE: Patients must meet laboratory criteria prior to initiation of the alectinib lead-in cycle and prior to initiation of combination therapy with duvelisib
Able to swallow pills.
Able to take prophylactic medications against Pneumocystis jirovecii pneumonia (PJP)
Women of reproductive potential must have a negative serum or urine β human chorionic gonadotropin (β-HCG) pregnancy test within 14 days before initiating therapy.
Females of childbearing age must be on effective contraception per institutional standards during the treatment period and for 5 weeks after the last dose of the study drugs.
Males must consistently use an effective contraception method per institutional standards during the treatment period and for 3 months following the last dose of the study drugs.

Exclusion

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.
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.
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.
Pregnant or breastfeeding women.
Any serious or unstable medical condition, laboratory abnormality, or psychiatric illness that would prevent the patient from signing informed consent or, in the investigator's judgment, increase the risk to the patient associated with participation in the study

What this trial measures

  • Determine the maximum tolerated dose (MTD)2 years

    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%.