Clinical trial · Interventional
Itacitinib and Alemtuzumab in Treating Patients With T-Cell Prolymphocytic Leukemia
Phase Ib Pilot Study of Itacitinib With Alemtuzumab in Patients With T-Cell Prolymphocytic Leukemia (T-PLL)
NCT03989466CI-TRIAL-00081467completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This phase Ib trial studies the side effects and best dose of alemtuzumab when given together with itacitinib in treating patients with T-cell prolymphocytic leukemia. Itacitinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Immunotherapy with alemtuzumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Giving itacitinib and alemtuzumab may work better in treating patients with T-cell prolymphocytic leukemia compared to standard of care treatment.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent T-Cell Prolymphocytic Leukemia | T-Cell Prolymphocytic Leukemia | CURATED_BROADER | 0.78 |
| T-Cell Prolymphocytic Leukemia | T-Cell Prolymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Alemtuzumab | Biological | Alemtuzumab | ALIAS |
| Itacitinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (itacitinib, alemtuzumab)
- description
- CYCLE 1: Patients receive itacitinib PO QD on days 1-28 and alemtuzumab IV over 2 hours on days 15, 17, 19, 21, 23, 25, and 27 in the absence of disease progression of unacceptable toxicity. CYCLE 2 AND BEYOND: Patients receive itacitinib PO QD on day 1-28 and alemtuzumab IV over 2 hours on days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, and 27. Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Patients who achieve a response (CR/CRi or PR) may receive itacitinib for up to 8 additional cycles in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Biological: Alemtuzumab
- Drug: Itacitinib
Primary outcomes (1)
- measure
- Incidence of adverse events (AEs)
- timeFrame
- Up to 2 years
- description
- The severity of the toxicities will be graded according to the latest version of National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE). The number and percent of subjects with treatment-emergent adverse events will be summarized according to intensity and drug relationship, and categorized by System Organ Class and preferred term by dose level/Part. All reported AEs that occur after signing informed consent will be included in the analysis of all reported AEs. Exposure to study drug and reasons for discontinuation of study drug will be tabulated. Data will be summarized using descriptive statistics. Continuous variables will be summarized using the number of observations, mean, standard deviation, coefficient of variation, median, and range as appropriate. Categorical values will be summarized using the number of observations and percentages as appropriate.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with a diagnosis of T-cell prolymphocytic leukemia (T-PLL) will be eligible (both treatment naïve and relapsed patients are eligible). * Age \>/= 18 years. * Patients must not have had chemotherapy or antibody therapy for 7 days prior to starting ITACITINIB. However, patients with rapidly proliferative disease may receive hydroxyurea or decadron until 24 hours prior to starting therapy on this protocol. * Adequate organ function as defined below: liver function (bilirubin \</=2mg/dL, AST and ALT \</=3 x ULN or \</=5 x ULN if related to leukemic involvement); kidney function (estimated creatinine clearance \> 50); known cardiac ejection fraction of \> or = 45% within the past 3 months; and platelet count \</=30,000. * ECOG performance status of \</= 2. * A negative urine pregnancy test is required within 1 week for all women of childbearing potential prior to enrolling on this trial. * Patient must have the ability to understand the requirements of the study and signed informed consent. A signed informed consent by the patient or his legally authorized representative is required prior to their enrollment on the protocol. Exclusion Criteria: * Patients with a diagnosis of T-cell prolymphocytic leukemia (T-PLL) will be eligible (both treatment naïve and relapsed patients are eligible). * Age \>/= 18 years. * Patients must not have had chemotherapy or antibody therapy for 7 days prior to starting ITACITINIB. However, patients with rapidly proliferative disease may receive hydroxyurea or decadron until 24 hours prior to starting therapy on this protocol. * Adequate organ function as defined below: liver function (bilirubin \</=2mg/dL, AST and ALT \</=3 x ULN or \</=5 x ULN if related to leukemic involvement); kidney function (estimated creatinine clearance \> 50); known cardiac ejection fraction of \> or = 45% within the past 3 months; and platelet count \</=30,000. * ECOG performance status of \</= 2. * A negative urine pregnancy test is required within 1 week for all women of childbearing potential prior to enrolling on this trial. * Patient must have the ability to understand the requirements of the study and signed informed consent. A signed informed consent by the patient or his legally authorized representative is required prior to their enrollment on the protocol.
References
Publications (1)
- DERIVEDKadia TM, Jain A, Rausch CR, Bataller A, Ravandi F, Jabbour E, Qiao W, Borthakur G, Short N, Montalban-Bravo G, Quesada AE, Burger J, Ferrajoli A, Wierda W, Hosing C, Kantarjian H. Phase 1B pilot study of itacitinib with alemtuzumab in patients with T-cell prolymphocytic leukemia. Blood Neoplasia. 2025 Oct 24;3(1):100175. doi: 10.1016/j.bneo.2025.100175. eCollection 2026 Feb. PMID 41536780