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

Part of paid clinical trials in Basking Ridge, New Jersey.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT07001384
Phase
PHASE1
Status
Recruiting
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Conditions

  • Anaplastic Large Cell Lymphoma
  • Anaplastic Lymphoma Kinase

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Alectinib — DRUG
    All patients will receive a lead-in cycle (28 days) of alectinib.
  • Duvelisib — DRUG
    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.

Study Details

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

Key Dates

Start date
Aug 8, 2025
Status verified
May 2026
Primary completion
Aug 8, 2031
Completion
Aug 8, 2031

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Alectinib and Duvelisib
    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.

Primary Outcome Measure

Determine the maximum tolerated dose (MTD) [ Time Frame: 2 years ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering Basking Ridge (LimitedProtocol Activities)Basking RidgeNew Jersey07920
Robert Stuver, MD
646-608-4308
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)MiddletownNew Jersey07748
Robert Stuver, MD
646-608-4308
Memorial Sloan Kettering Bergen (Limited Protocol Activities)MontvaleNew Jersey07645
Robert Stuver, MD
646-608-4308
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)CommackNew York11725
Robert Stuver, MD
646-608-4308
Memorial Sloan Kettering Westchester (Limited Protocol Activities)HarrisonNew York10604
Robert Stuver, MD
646-608-4308
Memorial Sloan Kettering Cancer Center (All Protocol Activities)New YorkNew York10065
Robert Stuver, MD
646-608-4308
Memorial Sloan Kettering Nassau (Limited Protocol Activities)UniondaleNew York11553
Robert Stuver, MD
646-608-4308

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Memorial Sloan Kettering Basking Ridge (LimitedProtocol Activities)· Basking Ridge, NJMemorial Sloan Kettering Monmouth (Limited Protocol Activities)· Middletown, NJMemorial Sloan Kettering Bergen (Limited Protocol Activities)· Montvale, NJMemorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)· Commack, NYMemorial Sloan Kettering Westchester (Limited Protocol Activities)· Harrison, NYMemorial Sloan Kettering Cancer Center (All Protocol Activities)· New York, NY

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