Trial · NCT05626322
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase 1b: Number of Participants With Dose Limiting Toxicities (DLTs) | Cycle 1 (28 Days) | DLTs included: Hematological: Grade (G) 4 thrombocytopenia (\<25,000/microliter \[mcL\]) lasting \>=72 hours or a platelet count \<=10,000/mcL at any time, unexplained by underlying disease; \>=G3 thrombocytopenia associated with \>=G2 bleeding, unexplained by underlying disease. G4 anemia; unexplained by underlying disease; G4 neutropenia lasting \>=7 days, unexplained by underlying disease; G3 febrile (\>38.3-degree Celsius \[C\]) neutropenia lasting \>=7 days, unexplained by underlying disease; G4 febrile neutropenia unexplained by underlying disease. Non-hematological: any treatment-related \>=G3 non-hematologic toxicity; Other \>=G2 PF-07901801-related non-hematologic toxicities that, in the opinion of the investigator, required a dose reduction or discontinuation of PF-07901801 were considered a DLT. |
| Secondary | Phase 1b: Number of Participants With Treatment Emergent Adverse Events (TEAEs) | From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure) | An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs are those events with onset dates occurred during the on-treatment period for the first time, or if the worsening of an event is during the on-treatment period. |
| Secondary | Phase 1b: Number of Participants With Serious Treatment Emergent Adverse Events | From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure) | An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria - resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/ incapacity, was a congenital anomaly/birth defect or other important medical event. TEAEs are those events with onset dates occurred during the on-treatment period for the first time, or if the worsening of an event is during the on-treatment period. |
| Secondary | Phase 1b: Number of Participants With Treatment-Related AEs | From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure) | An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Related AEs were those related to any study drug (i.e., at least one of the study drugs) reported by the investigator. |
| Secondary | Phase 1b: Number of Participants With Grade Shift From Baseline in Hematology Parameters to Any Time Post-baseline | From baseline (latest non-missing value from pre-treatment period) up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure) | The following hematological parameters were assessed: anemia, hemoglobin increased, leukocytosis, lymphocyte count decreased, lymphocyte count increased, neutrophil count decreased, platelet count decreased, and white blood cell (WBC) decreased. Lab abnormalities were graded according to National Cancer Institute Common Terminology Criteria for AEs (NCI CTCAE) version (v) 5.0 where Grade 0= no AE, Grade 1= mild AE, Grade 2 =moderate AE, Grade 3= severe AE, and Grade 4= life-threatening consequences; urgent intervention indicated. Only those parameters with at least 1 non-zero data values showing any shift in grades from Baseline to any time post-baseline in any reporting group were reported in this outcome measure. Participants whose grade category was unchanged (e.g. Grade 0 to Grade 0) were not reported. |
| Secondary | Phase 1b: Number of Participants With Grade Shift From Baseline in Chemistry Parameters to Any Time Post Baseline | From baseline (latest non-missing value from pre-treatment period) up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure) | The following clinical chemistry parameters were assessed: alanine aminotransferase increased, alkaline phosphatase increased, aspartate aminotransferase increased, blood bilirubin increased, creatinine increased, hypercalcemia, hyperkalemia, hypermagnesemia, hypernatremia, hypoalbuminemia, hypocalcemia, hypoglycemia, hypokalemia, hypomagnesemia and hyponatremia. Lab abnormalities were graded according to NCI CTCAE v5.0 where Grade 0= no AE, Grade 1=mild AE, Grade 2 = moderate AE, Grade 3 =severe AE, and Grade 4 =life-threatening consequences; urgent intervention indicated. Only those parameters with at least 1 non-zero data values showing any shift in grades from Baseline to any time post-baseline in any reporting group were reported in this outcome measure. Participants whose grade category was unchanged (e.g. Grade 0 to Grade 0) were not reported. |
| Secondary | Phase 1b: Percentage of Participants With Objective Response (OR) as Per Lugano Response Classification Criteria 2014 as Assessed by the Investigator | From date of first dose until first documentation of disease progression (PD), death or start of new anticancer therapy, whichever occurred first (maximum up to 14.2 months) | OR:best overall response (BOR) of complete response (CR) or partial response (PR) per Lugano Response Classification Criteria 2014 as determined by investigator. CR:positron emission tomography-computed tomography (PET-CT) score 1 (complete metabolic response), 2 (likely benign), or 3 (uncertain significance) with or without a residual mass on Deauville five-point scale (\[5PS\] standardized scoring system used to evaluate the extent of disease activity in patients with lymphoma through PET scans, ranging from 1 to 5, higher scores indicates more disease activity) or on computed tomography (CT),target nodes/nodal masses regressed to \<=1.5 centimeter (cm) in longest diameter (LDi). PR:PET-CT score 4 (possible residual disease) or 5 (progressive disease) with reduced uptake compared with baseline and residual mass(es) of any size or On CT \>=50% decrease in sum of the product of the diameters (SPD) of up to 6 target measurable nodes and extra nodal sites. 95% CI was based on Wilson method. |
| Secondary | Phase 1b: Duration of Response (DoR) as Per Lugano Response Classification Criteria 2014 as Assessed by the Investigator | From first documentation of OR until PD or death due to any cause whichever occurred first or date of censoring (maximum up to 14.2 months) | DoR: time from first documentation of OR until PD, or death due to any cause, whichever occurred first. DoR was censored on date of last adequate disease assessment for participants without an event. OR=BOR of CR or PR,CR=PET-CT score 1,2,or 3 with/without a residual mass on Deauville five-point scale(1 to 5,higher scores=more disease activity)or on CT,target nodes/nodal masses regressed to \<=1.5cm in LDi. PR:PET-CT score 4 or 5 with reduced uptake compared with baseline and residual mass of any size or On CT \>=50% decrease in SPD of up to 6 target measurable nodes and extra nodal sites. PD:PET-CT score 4 or 5 with increase in intensity of uptake from baseline and/or new fluorodeoxyglucose (FDG)-avid foci consistent with lymphoma at interim or end-of-treatment assessment or on CT,an individual abnormal node/lesion with: LDi\>1.5cm and increase by \>=50% from product of perpendicular diameters nadir and increase in LDi or SDi from nadir 0.5cm for lesions \<=2cm and 1.0cm for lesions \>2cm. |
| Secondary | Phase 1b: Percentage of Participants With CR as Per Lugano Response Classification Criteria 2014 as Assessed by the Investigator | From date of first dose until first documentation of CR (maximum up to 14.2 months) | CR as per Lugano Response Classification Criteria 2014 as assessed by the investigator was defined as: PET-CT score 1 (complete metabolic response), 2 (likely benign), or 3 (uncertain significance) with or without a residual mass on 5PS (standardized scoring system used to evaluate the extent of disease activity in patients with lymphoma through PET scans, ranging from 1 to 5, higher scores indicates more disease activity) or on CT, target nodes/nodal masses regressed to \<=1.5 cm in LDi. |
| Secondary | Phase 1b: Duration of Complete Response (DoCR) as Per Lugano Response Classification Criteria 2014 as Assessed by the Investigator | From time of first documentation of CR until PD, or death due to any cause, whichever occurred first or date of censoring (maximum up to 14.2 months) | DoCR:time from first documentation of CR until PD,or death, whichever occurred first. CR:PET-CT 1(complete metabolic response),2(likely benign),3(uncertain significance)with or without residual mass on 5PS(scale from 1 to 5,higher scores=more disease activity)/CT,target nodes/nodal masses regressed \<=1.5cm in LDi.PD:PET-CT 4(possible residual disease)or 5(PD)with increase intensity of uptake and new FDG-avid foci consistent with lymphoma at interim/EOT assessment/CT,individual abnormal node/lesion with:LDi \>1.5cm and increase \>=50% from PPD nadir, increase in LDi or SDi from nadir 0.5cm for lesions \<=2cm and 1.0cm for lesions \>2cm. DoCR censored on date of last adequate assessment for participants without an event on date of last adequate disease assessment before new anti-cancer therapy if new anti-cancer therapy started prior to event,date of last adequate disease assessment before 2 or more missing disease assessments for participants with event after 2 or more missing assessments. |
| Secondary | Phase 1b: Progression Free Survival (PFS) as Per Lugano Response Classification Criteria 2014 as Assessed by the Investigator | From date of first dose until PD or death due to any cause, whichever occurred first or censoring date (maximum up to 14.2 months) | PFS: time from date of first dose until PD per Lugano Response Classification Criteria 2014 or death due to any cause,whichever occurred first.Participants without any event,censored on date of last adequate disease assessment;participants with new anticancer therapy prior to an event,censored on date of last disease assessment before new anticancer therapy;participants with an event after a gap of 2 or more missing disease assessments,censored on date of last disease assessment before gap;participants without an adequate post-baseline disease assessment were censored on date of first dose of study intervention unless death occurred on or before time of second planned disease assessment in which case death was considered an event.PD:PET-CT score 4 or 5 with increase in intensity of uptake from baseline and/or new FDG or LDi\>1.5cm and increase by \>=50% from product of perpendicular diameters nadir and increase in LDi or SDi from nadir 0.5cm for lesions \<=2cm and 1.0cm for lesions \>2cm. |
| Secondary | Phase 1b: Plasma Concentration of PF-07901801 | Cycle 1 and 2 Day 1: Predose, 1 Hour (H) and 5H post dose; Cycle 1 Day 8: pre-dose, Day 1 of Cycles 3, 4, 5, 7, 10 and 13: Predose | All concentrations assayed below the level of quantification (BLQ) were set to 0 and their data is not reported in this outcome measure. |
| Secondary | Phase 1b: Number of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (NAb) Against PF-07901801 | From first dose of the study treatment (Day 1) up to end of study treatment (maximum up to 14.2 months) | Number of participants with ADA and NAb against PF-07901801 were reported in this outcome measure. A participant was ADA (or NAb) positive if: (1) baseline titer was missing or negative and participant had \>= 1 post-treatment positive titer (treatment-induced), or (2) positive titer at baseline and had a \>= 4-folder dilution increase in titer from baseline in \>= 1 post-treatment sample (treatment-boosted). |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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