OncoMatch/Clinical Trials/NCT07001384
A Study of Alectinib and Duvelisib in People With Anaplastic Lymphoma Kinase-Positive Anaplastic Large Cell Lymphoma (ALK+ALCL)
Is NCT07001384 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Alectinib and Duvelisib for anaplastic lymphoma kinase.
Treatment: Alectinib · Duvelisib — 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
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Hodgkin Lymphoma
Biomarker criteria
Required: ALK overexpression
ALK+ ALCL by definition expresses ALK, which is readily detectable on standard IHC
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: cytotoxic chemotherapy
Prior systemic therapy must have included at least one cytotoxic chemotherapy agent
Cannot have received: allogeneic stem cell transplant
Exception: allowed if >6 months prior and no active GVHD
Prior allogeneic stem cell transplant within 6 months of starting treatment or patients with active graft versus host disease (GVHD)
Cannot have received: systemic anti-cancer therapy
Exception: allowed if >7 days prior to study drug; systemic corticosteroids allowed if ≤10 mg/day prednisone equivalent; localized radiotherapy may be allowed with shorter washout after discussion with PI
Previous systemic anti-cancer therapy for ALK+ ALCL within 7 days of initiating study drug
Lab requirements
Blood counts
Absolute neutrophil count ≥ 1.0 K/mcL or ≥ 0.5 K/mcL if due to lymphoma (growth factor allowed). Platelet count ≥ 75 K/uL.
Kidney function
Calculated creatinine clearance ≥ 60 mL/min by Cockcroft-Gault
Liver function
Total bilirubin ≤ 2x ULN or ≤ 3x ULN if due to hepatobiliary involvement with lymphoma, or ≤ 3x ULN if history of Gilbert's disease. AST and ALT ≤ 3x ULN or ≤ 5x ULN if due to hepatobiliary involvement with lymphoma.
Laboratory criteria: Absolute neutrophil count ≥ 1.0 K/mcL or ≥ 0.5 K/mcL if due to lymphoma (growth factor allowed). Platelet count ≥ 75 K/uL. Calculated creatinine clearance ≥ 60 mL/min by Cockcroft-Gault. Total bilirubin ≤ 2x ULN or ≤ 3x ULN if due to hepatobiliary involvement with lymphoma, or ≤ 3x ULN if history of Gilbert's disease. AST and ALT ≤ 3x ULN or ≤ 5x ULN if due to hepatobiliary involvement with lymphoma.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial 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
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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