Trial · NCT05626322
Effects of Maplirpacept (PF-07901801),Tafasitamab, and Lenalidomide in People With Relapsed or Refractory Diffuse Large B-cell Lymphoma
NCT05626322, Phase 1, Phase 2, Terminated, Pfizer; results first posted 2025-09-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Effects of Maplirpacept (PF-07901801),Tafasitamab, and Lenalidomide in People With Relapsed or Refractory Diffuse Large B-cell Lymphoma. Trials, record NCT05626322. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05626322
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effects of Maplirpacept (PF-07901801),Tafasitamab, and Lenalidomide in People With Relapsed or Refractory Diffuse Large B-cell Lymphoma
- NCT number
- NCT05626322
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 6 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Diffuse Large B-Cell Lymphoma
- Interventions
- Maplirpacept, Tafasitamab, Lenalidomide
- First posted
- 2022-11-23
- Last updated
- 2025-09-05
- Results first posted
- 2025-09-05
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group170
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Phase 1b: Number of Participants With Dose Limiting Toxicities (DLTs) | PF-07901801 4 mg/kg + Tafasitamab + Lenalidomide | 0 | Participants | ||
| Phase 1b: Number of Participants With Dose Limiting Toxicities (DLTs) | PF-07901801 10 mg/kg + Tafasitamab + Lenalidomide | 0 | Participants | ||
| Phase 1b: Number of Participants With Dose Limiting Toxicities (DLTs) | PF-07901801 18 mg/kg + Tafasitamab + Lenalidomide | 0 | Participants | ||
| Phase 1b: Number of Participants With Treatment Emergent Adverse Events (TEAEs) | PF-07901801 4 mg/kg + Tafasitamab + Lenalidomide | 3 | Participants | ||
| Phase 1b: Number of Participants With Treatment Emergent Adverse Events (TEAEs) | PF-07901801 10 mg/kg + Tafasitamab + Lenalidomide | 2 | Participants | ||
| Phase 1b: Number of Participants With Treatment Emergent Adverse Events (TEAEs) | PF-07901801 18 mg/kg + Tafasitamab + Lenalidomide | 1 | Participants | ||
| Phase 1b: Number of Participants With Serious Treatment Emergent Adverse Events | PF-07901801 4 mg/kg + Tafasitamab + Lenalidomide | 3 | Participants | ||
| Phase 1b: Number of Participants With Serious Treatment Emergent Adverse Events | PF-07901801 10 mg/kg + Tafasitamab + Lenalidomide | 0 | Participants | ||
| Phase 1b: Number of Participants With Serious Treatment Emergent Adverse Events | PF-07901801 18 mg/kg + Tafasitamab + Lenalidomide | 0 | Participants | ||
| Phase 1b: Number of Participants With Treatment-Related AEs | PF-07901801 4 mg/kg + Tafasitamab + Lenalidomide | 3 | Participants |
1 to 10 of 170Source ClinicalTrials.gov
See all 170 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | PF-07901801 4 mg/kg + Tafasitamab + Lenalidomide | 3 | |
| Overall Study | STARTED | PF-07901801 10 mg/kg + Tafasitamab + Lenalidomide | 2 | |
| Overall Study | STARTED | PF-07901801 18 mg/kg + Tafasitamab + Lenalidomide | 1 | |
| Overall Study | COMPLETED | PF-07901801 4 mg/kg + Tafasitamab + Lenalidomide | 0 | |
| Overall Study | COMPLETED | PF-07901801 10 mg/kg + Tafasitamab + Lenalidomide | 0 | |
| Overall Study | COMPLETED | PF-07901801 18 mg/kg + Tafasitamab + Lenalidomide | 0 | |
| Overall Study | NOT COMPLETED | PF-07901801 4 mg/kg + Tafasitamab + Lenalidomide | 3 | |
| Overall Study | NOT COMPLETED | PF-07901801 10 mg/kg + Tafasitamab + Lenalidomide | 2 | |
| Overall Study | NOT COMPLETED | PF-07901801 18 mg/kg + Tafasitamab + Lenalidomide | 1 |
Source ClinicalTrials.gov
Adverse events201
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | PF-07901801 4 mg/kg + Tafasitamab + Lenalidomide | 1 | 3 | |
| other | Anaemia | Blood and lymphatic system disorders | PF-07901801 10 mg/kg + Tafasitamab + Lenalidomide | 0 | 2 | |
| other | Anaemia | Blood and lymphatic system disorders | PF-07901801 18 mg/kg + Tafasitamab + Lenalidomide | 0 | 1 | |
| other | Lymph node pain | Blood and lymphatic system disorders | PF-07901801 4 mg/kg + Tafasitamab + Lenalidomide | 0 | 3 | |
| other | Lymph node pain | Blood and lymphatic system disorders | PF-07901801 10 mg/kg + Tafasitamab + Lenalidomide | 1 | 2 | |
| other | Lymph node pain | Blood and lymphatic system disorders | PF-07901801 18 mg/kg + Tafasitamab + Lenalidomide | 0 | 1 | |
| other | Vision blurred | Eye disorders | PF-07901801 4 mg/kg + Tafasitamab + Lenalidomide | 1 | 3 | |
| other | Vision blurred | Eye disorders | PF-07901801 10 mg/kg + Tafasitamab + Lenalidomide | 0 | 2 | |
| other | Vision blurred | Eye disorders | PF-07901801 18 mg/kg + Tafasitamab + Lenalidomide | 0 | 1 | |
| other | Visual impairment | Eye disorders | PF-07901801 4 mg/kg + Tafasitamab + Lenalidomide | 0 | 3 |
1 to 10 of 201Source ClinicalTrials.gov
See all 201 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | PF-07901801 4 mg/kg + Tafasitamab + Lenalidomide | 2 | 3 |
| Total, all-cause mortality | PF-07901801 10 mg/kg + Tafasitamab + Lenalidomide | 0 | 2 |
| Total, all-cause mortality | PF-07901801 18 mg/kg + Tafasitamab + Lenalidomide | 0 | 1 |
| Total, other adverse events | PF-07901801 4 mg/kg + Tafasitamab + Lenalidomide | 3 | 3 |
| Total, other adverse events | PF-07901801 10 mg/kg + Tafasitamab + Lenalidomide | 2 | 2 |
| Total, other adverse events | PF-07901801 18 mg/kg + Tafasitamab + Lenalidomide | 1 | 1 |
| Total, serious adverse events | PF-07901801 4 mg/kg + Tafasitamab + Lenalidomide | 3 | 3 |
| Total, serious adverse events | PF-07901801 10 mg/kg + Tafasitamab + Lenalidomide | 0 | 2 |
| Total, serious adverse events | PF-07901801 18 mg/kg + Tafasitamab + Lenalidomide | 0 | 1 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05626322
GET https://conductscience.org/api/trials/v1/NCT05626322/results?page=2