Trial · NCT05626322
Outcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Phase 1b: Number of Participants With Dose Limiting Toxicities (DLTs) | Cycle 1 (28 Days) | DLT evaluable set included all enrolled participants who received at least 1 dose of the study treatment in the Phase 1b of the study and either experienced DLTs or completed the DLT observation period without DLT. | Participants | COUNT_OF_PARTICIPANTS |
| 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) | Safety analysis set included all enrolled participants who received at least 1 dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| 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) | Safety analysis set included all enrolled participants who received at least 1 dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| 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) | Safety analysis set included all enrolled participants who received at least 1 dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| 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) | Safety analysis set included all enrolled participants who received at least 1 dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| 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) | Safety analysis set included all enrolled participants who received at least 1 dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| 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) | Safety analysis set included all enrolled participants who received at least 1 dose of study treatment. | Percentage of participants | NUMBER |
| 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) | Safety analysis set included all enrolled participants who received at least 1 dose of study treatment. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure. Only participants with objective response were included in the analysis. | Months | MEDIAN |
| 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) | Safety analysis set included all enrolled participants who received at least 1 dose of study treatment. | Percentage of participants | NUMBER |
| 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) | Safety analysis set included all enrolled participants who received at least 1 dose of study treatment. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure. Only participants with complete response were included in the analysis. | Months | MEDIAN |
| 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) | Safety analysis set included all enrolled participants who received at least 1 dose of study treatment. | Months | MEDIAN |
| 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 | The Pharmacokinetic (PK) analysis set included all participants in the safety analysis set who had at least 1 post-dose concentration measurement. Here, Number Analyzed signifies number of participants evaluable at specified timepoints. The participant in PF-07901801 18 mg/kg + Tafasitamab + Lenalidomide withdrew consent hence, the Overall Number of Participants Analyzed is reported as 0. | Micrograms per milliliter | GEOMETRIC_MEAN |
| 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) | Immunogenicity analysis set included all participants in the safety analysis set who had at least 1 sample tested for ADA. | Participants | COUNT_OF_PARTICIPANTS |
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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