Alectinib + Duvelisib for Anaplastic Large Cell Lymphoma

Recruiting at 6 trial locations

Overseen By Robert Stuver, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Memorial Sloan Kettering Cancer Center

Must be taking: ALK inhibitors

Must not be taking: CYP3A inhibitors

Disqualifiers: Active GVHD, Hepatitis B, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: 2

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether alectinib (a cancer treatment) and duvelisib (a PI3K inhibitor) can safely and effectively treat individuals with ALK+ anaplastic large cell lymphoma, a type of blood cancer that has returned or resisted previous treatments. Researchers aim to identify the highest doses of these drugs that cause only mild side effects and to determine the duration of their effects. Individuals who have undergone at least one prior treatment for ALK+ lymphoma, including chemotherapy, and can manage daily life while on an ALK inhibitor might be suitable candidates for this trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial does not specify if you must stop all current medications, but you cannot be on certain medications like CYP4503A inhibitors or inducers. If you're on corticosteroids, they must be reduced to 10 mg/day or less before starting the trial. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that using alectinib and duvelisib together might be safe and manageable for treating patients with ALK-positive anaplastic large cell lymphoma. In early studies, patients took these drugs without major side effects. However, this research remains in the early stages, requiring more information to fully understand the treatment's safety. So far, the drugs have shown promise and are being carefully tested to determine the best dose with the fewest side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Alectinib and Duvelisib for treating Anaplastic Large Cell Lymphoma because these drugs work differently from standard chemotherapy. Alectinib is a targeted therapy that specifically inhibits ALK (anaplastic lymphoma kinase), which is often involved in the growth of cancer cells. Duvelisib, on the other hand, targets specific pathways inside cancer cells (PI3K-delta and PI3K-gamma) to slow down or stop their growth. This combination offers a more focused approach compared to conventional treatments, potentially leading to fewer side effects and improved outcomes for patients.

What evidence suggests that alectinib and duvelisib might be an effective treatment for anaplastic large cell lymphoma?

Research has shown that alectinib and duvelisib might work well together to treat ALK-positive anaplastic large cell lymphoma (ALCL). In this trial, all participants initially receive a lead-in cycle of alectinib. Alectinib blocks a protein that helps this cancer grow, while duvelisib interferes with signals cancer cells need to survive. After the lead-in cycle, participants receive two cycles of alectinib plus duvelisib, provided there is no progressive disease. Some studies suggest this combination could be safe and effective, but more research is needed. Early results are promising, but the duration of the benefits remains under investigation. ^{1 2 3 4 5}

Who Is on the Research Team?

Robert Stuver, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for individuals with relapsed or refractory ALK+ anaplastic large cell lymphoma (ALCL). Participants should have a specific type of lymphoma that has returned after treatment or hasn't responded to previous treatments. Detailed eligibility criteria are not provided, but typically include factors like age, health status, and prior therapies.

Inclusion Criteria

Laboratory criteria: Absolute neutrophil count ≥ 1.0 K/mcL or ≥ 0.5 K/mcL if due to lymphoma, Platelet count ≥ 75 K/uL, Calculated creatinine clearance ≥ 60 mL/min by Cockcroft-Gault, Total bilirubin ≤ 2x upper limit of normal or ≤ 3x ULN if due to hepatobiliary involvement with lymphoma or history of Gilbert's disease, Aspartate (AST) and alanine (ALT) aminotransferase ≤ 3 x ULN or ≤ 5x ULN if due to hepatobiliary involvement with lymphoma

Able to swallow pills

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

Exclusion Criteria

Any serious or unstable medical condition, laboratory abnormality, or psychiatric illness that would prevent the patient from signing informed consent or increase the risk associated with participation in the study

I am not taking any medications that strongly affect liver enzymes.

Pregnant or breastfeeding women

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Lead-in Cycle

Participants receive a lead-in cycle of alectinib for 28 days, followed by a PET/CT scan and safety assessment

4 weeks

1 visit (in-person) for PET/CT scan and safety assessment

Combination Treatment

Participants receive two 28-day cycles of alectinib plus duvelisib, followed by a response assessment

8 weeks

1 visit (in-person) for response assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Alectinib
• Duvelisib

Trial Overview The study is testing the combination of two drugs: Alectinib and Duvelisib. It aims to determine the safest and most effective doses when used together as a time-limited treatment for ALK+ ALCL. Researchers will first find the best dose with minimal side effects before assessing how long its effects last post-treatment.

How Is the Trial Designed?

Group I: Alectinib and Duvelisib Experimental Treatment 2 Interventions

All patients will receive a lead-in cycle (28 days) of alectinib. After this cycle, patients will undergo a PET/CT scan and safety assessment. Patients without progressive disease will continue on therapy. After the lead-in cycle of alectinib, in the absence of progressive disease as assessed by PET/CT scan, all patients will then receive two 28-day cycles of alectinib plus duvelisib. After two cycles of combination therapy, patients will undergo a response assessment.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Genentech, Inc.

Industry Sponsor

Trials

1,578

Recruited

569,000+

Ashley Magargee

Genentech, Inc.

Chief Executive Officer since 2024

MBA from Harvard University, BA from Princeton University

Levi Garraway

Genentech, Inc.

Chief Medical Officer since 2021

MD, PhD

Secura Bio, Inc.

Industry Sponsor

Trials

9

Recruited

200+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07001384

NCT07001384 | A Study of Alectinib and Duvelisib in ... 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 ...

2. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2025-05949

Alectinib in Combination with Duvelisib for the Treatment of ... Giving alectinib in combination with duvelisib may be safe and tolerable in treating patients with ALK-positive anaplastic large cell lymphoma.

3. mskcc.org mskcc.org/cancer-care/clinical-trials/25-056

A Phase 1 Study of Alectinib Plus Duvelisib in People With ... It works by blocking the ALK fusion protein. These drugs work well. But people usually have to take them for long periods of time, because there is a risk of ...

4. app.trialscreen.org app.trialscreen.org/trials/phase-1-alectinib-duvelisib-people-anaplastic-lymphoma-kinase-positive-trial-nct07001384

A Phase 1 study of Alectinib and Duvelisib in ALK+ ALCL Benefits: Participants will receive a novel combination treatment that may be effective against their cancer. Their participation will also help researchers ...

5. withpower.com withpower.com/trial/phase-1-lymphoma-large-cell-anaplastic-7-2025-4227e

Alectinib + Duvelisib for Anaplastic Large Cell Lymphoma 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 ...