Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Symptoms and General Pathology

Rare Diseases

Lymphoma

Leukemia

Leukemia, Lymphoid

Leukemia, Lymphocytic, Chronic, B-Cell

Lymphoma, Non-Hodgkin

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Hematologic Diseases

Leukemia, B-Cell

Chronic Disease

Disease Attributes

Lymphosarcoma

Chronic Graft Versus Host Disease

Chronic Lymphocytic Leukemia

All Drugs and Chemicals

Antibodies

Antibodies, Monoclonal

Immunoglobulins

Participants will be assigned to disease specific cohorts based on the histology of their underlying disease.

Cohort 1: R/R DLBCL Cohort 2: R/R MCL Cohort 3: R/R FL Cohort 4: R/R MZL Cohort 5: R/R CLL/SLL

tafasitamab will be administered at a protocol defined dose once a week for cycles 1-3 and every other week from cycle 4 until progression.

tafasitamab

parsaclisib will be administered at protocol defined dose for cycles 1 through disease progression.

parsaclisib

Oliver Manzke, MD

The purpose of this single-arm, open-label, Phase 1b/2a, multicenter basket study is to evaluate whether tafasitamab and parsaclisib can be safely combined at the recommended Phase 2 dose (RP2D) and dosing regimen that was established for each of the 2 compounds as a treatment option for adult participants with R/R B-cell malignancies.

A Study Evaluating Safety, PK, and Efficacy of Tafasitamab and Parsaclisib in Participants With Relapsed/Refractory Non Hodgkin Lymphoma (R/R NHL) or Chronic Lymphocytic Leukemia (CLL)

A Phase 1b/2a Basket Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Combination Therapy With the Anti CD19 Monoclonal Antibody Tafasitamab and the PI3Kδ Inhibitor Parsaclisib in Adult Participants With Relapsed/Refractory Non Hodgkin Lymphoma or Chronic Lymphocytic Leukemia

Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency

Any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug.

Dose-limiting toxicity will be defined as the occurrence of any of the toxicities as per protocol. All DLTs will be assessed for severity by the investigator using CTCAE v5.0 criteria.

Defined as the percentage of participants experiencing a best response of Complete Response/Complete Metabolic Response (CR/CMR) or Partial Response/Partial Metabolic Response (PR/PMR) according to the Lugano criteria (Cheson et al 2014) for NHL and the iwCLL criteria (Hallek et al 2018) for CLL.

Maximum Observed Plasma Concentration of tafasitamab

Minimum Observed Plasma Concentration of tafasitamab

Time to reach maximum plasma concentration of tafasitamab

Area under the concentration-time curve from time zero to time of tafasitamab

Incyte Corporation

Lymphoma, Follicular

Lymphoma, B-Cell, Marginal Zone

Lymphoma, B-Cell

Follicular Lymphoma

Marginal Zone Lymphoma

B-cell Lymphoma

Antineoplastic Agents

Antirheumatic Agents

Rituximab

Lenalidomide

Antineoplastic Agents, Immunological

Immunologic Factors

Angiogenesis Inhibitors

Growth Inhibitors

Adult patients with Relapsed/Refractory (R/R) Follicular Lymphoma (FL) Grade 1 to 3a or R/R Marginal Zone Lymphoma (MZL)

tafasitamab will be administered IV for 12 cycles

Rituximab will be administered IV on cycles 1 - 5

rituximab

Lenalidomide will be administered PO for 12 cycles

lenalidomide

placebo will be administered IV for 12 cycles

placebo

This is a Phase 3 double-blind, placebo-controlled, randomized study designed to investigate whether tafasitamab and lenalidomide as an add-on to rituximab provides improved clinical benefit compared with lenalidomide as an add-on to rituximab in patients with R/R FL Grade 1 to 3a or R/R MZL.

A Phase 3 Study to Assess Efficacy and Safety of Tafasitamab Plus Lenalidomide and Rituximab Compared to Placebo Plus Lenalidomide and Rituximab in Patients With Relapsed/Refractory (R/R) Follicular Lymphoma or Marginal Zone Lymphoma.

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Tafasitamab Plus Lenalidomide in Addition to Rituximab Versus Lenalidomide in Addition to Rituximab in Patients With Relapsed/Refractory (R/R) Follicular Lymphoma Grade 1 to 3a or R/R Marginal Zone Lymphoma

Defined as the time from randomization to first documented disease progression, or death from any cause, whichever occurs first.

Defined as number of participants with complete response par Positron Emission Tomography(PET) at the end of treatment visit

Defined as less than 1 residual tumor cell per 10\^4 normal cells in peripheral blood and bone marrow.

Defined as survival from time of study randomization to death of any cause.

Defined as survival from time of study initiation to death of any cause.

Defined as proportion of participants whose best overall response was a complete response (CR) or partial response (PR).

Defined as the time to the first response to evidence of progression.

Defined as a patient self evaluation questionnaire

Defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study treatment up to 30 days after last dose of study treatment.

Lymphoma, Large B-Cell, Diffuse

Diffuse Large B-Cell Lymphoma

Anti-Inflammatory Agents

Antiemetics

Neuroprotective Agents

Gastrointestinal Agents

Cyclophosphamide

Doxorubicin

Liposomal doxorubicin

Vincristine

Prednisolone

Methylprednisolone

Methylprednisolone Acetate

Methylprednisolone Hemisuccinate

Prednisolone acetate

Prednisolone hemisuccinate

Prednisolone phosphate

Dose-finding to evaluate the safety and tolerability and to determine the RP2Ds of single-agent tafasitamab in Japanese participants with NHL. Part 1 consists of 1 group (Group 1) to evaluate weight-based doses of tafasitamab.

tafasitamab will be combined with lenalidomide (Group 3) or parsaclisib (Group 4a) in R/R DLBCL participants or lenalidomide plus R-CHOP (Group 5) in previously untreated DLBCL participants. Modified tafasitamab dosing when combined with lenalidomide (Group 2) in participants with R/R DLBCL will be evaluated to determine the recommended clinical dose. The dose of tafasitamab will be based on the weight-based RP2D that is deemed safe and tolerable in Part 1.

tafasitamab in combination with parsaclisib will be further evaluated in Group 4b at RP2D determined in Part 2

tafasitamiab in combination with lenalidomide will be further evaluated in Group 6 at RP2D determined in Part 2.

tafasitamab will be administered at protocol defined timepoints based on the groups participants are assigned.

lenalidomide will be administered orally at protocol defined timepoints based on the groups participants are assigned.

parsaclisib will be administered at protocol defined timepoints based on the groups participants are assigned.

R-CHOP is a combination regimen consisting of rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone. R-CHOP will be administered at protocol defined timepoints based on the groups participants are assigned.

R-CHOP

Incyte Biosciences Japan GK Development Operations Call Center

This is an open-label, multicenter study to evaluate safety and tolerability, determine the RP2Ds of tafasitamab alone in Japanese participants with R/R NHL, or to evaluate efficacy and safety of tafasitamab in combination with lenalidomide in Japanese participants with R/R DLBCL, or tafasitimab in combination with lenalidomide plus R-CHOP in Japanese participants with previously untreated DLBC, or tafasitimab in combination with lenalidomide in Japanese participants with previously R/R DLBC.

To Assess the Safety and Tolerability of Tafasitamab Alone or in Combination With Other Drugs in Japanese Participants With Non-Hodgkins Lymphoma (NHL)

A Phase 1b/2 Study of Tafasitamab, Tafasitamab Plus Lenalidomide, Tafasitamab Plus Parsaclisib, and Tafasitamab Plus Lenalidomide in Combination With R-CHOP in Japanese Participants With Non-Hodgkin Lymphoma

Adverse events reported for the first time or worsening of a pre-existing event after first dose of study treatment.

Best Response of complete/complete metabolic response or partial/partial metabolic response

Minimum observed serum concentration over the dose interval.

Defined as the proportion of participants with Complete Response as determined by an IRC and investigator assessment according to the Lugano criteria

Defined as the time from the date of first documented evidence of CR or PR until the first documented disease progression or death from any cause, whichever occurs first, among participants who achieve an objective response as determined by IRC and investigator assessment based on the Lugano criteria for response assessment

Defined as the time from the date of randomization until the first documented disease progression as determined by IRC and investigator assessment based on the Lugano criteria for response assessment or death from any cause, whichever occurs first.

Defined as the time from the date of randomization until death from any cause.

Defined as the proportion of participants with a CR or PR as determined by the investigator based on the Lugano criteria for response assessment

Incyte Biosciences Japan GK

Tafasitamab and lenalidomide will be coadministered for up to 12 cycles (28 days per cycle).followed by tafasitamab monotherapy (in participants with stable disease or better) until treatment withdrawal criteria are met.

Tafasitamab will be administered intravenously in 28-day cycles. During Cycles 1 through 3, tafasitamab will be administered weekly on Days 1, 8, 15, and 22; an additional loading dose will be administered on Cycle 1 Day 4. Starting with Cycle 4, tafasitamab will be administered on Days 1 and 15 of each cycle.

Tafasitamab

Participants will self-administer lenalidomide capsules orally on Days 1-21 of each 28-day cycle, up to 12 cycles.

Incyte Corporation Call Center (US)

Incyte Corporation Call Center (ex-US)

The purpose of this study is to assess the efficacy and safety of of tafasitamab plus lenalidomide in adults with diffuse large B-cell lymphoma (DLBCL) who have relapsed or are refractory to at least 1 but no more than 3 previous systemic DLBCL treatment regimens and who are not eligible for high-dose chemotherapy (HDC) and autologous stem cell transplantation (ASCT).

Study to Evaluate the Safety and Efficacy of Tafasitamab Plus Lenalidomide in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (firmMIND)

A Phase 3, Single-Arm, Open-Label, Multicenter Study to Evaluate the Safety and Efficacy of Tafasitamab Plus Lenalidomide in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Percentage of participants having best response of Complete Response (CR) or Partial Response (PR) as per Independent Review Committee and investigator's assessment.

Defined as the time from the first documented CR or PR until the date of first documented disease progression or death due to any cause, whichever occurs first, among participants who achieve CR or PR per Independent Review Committee (IRC) assessment and investigator's assessment.

Defined as the time from the date of first dose until the first documented disease progression, or death due to any cause, whichever occurs first per IRC assessment and investigator's assessment.

Defined as the percentage of participants who achieve CR, PR, or SD as per IRC assessment and investigator's assessment.

Defined as the time from first dose until the initiation of new anticancer therapy or death due to any reason, whichever occurs first.

Defined as the time from the date of first dose until death due to any cause.

Defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study treatment up to 90 days after last dose of study treatment.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study Evaluating Safety, PK, and Efficacy of Tafasitamab and Parsaclisib in Participants With Relapsed/Refractory Non Hodgkin Lymphoma (R/R NHL) or Chronic Lymphocytic Leukemia (CLL)	NCT04809467	Chronic Lymphoc... Non Hodgkin Lym...	tafasitamab parsaclisib	18 Years -	Incyte Corporation
A Study Evaluating Safety, PK, and Efficacy of Tafasitamab and Parsaclisib in Participants With Relapsed/Refractory Non Hodgkin Lymphoma (R/R NHL) or Chronic Lymphocytic Leukemia (CLL)	NCT04809467	Chronic Lymphoc... Non Hodgkin Lym...	tafasitamab parsaclisib	18 Years -	Incyte Corporation
A Phase 3 Study to Assess Efficacy and Safety of Tafasitamab Plus Lenalidomide and Rituximab Compared to Placebo Plus Lenalidomide and Rituximab in Patients With Relapsed/Refractory (R/R) Follicular Lymphoma or Marginal Zone Lymphoma.	NCT04680052	Follicular Lymp... Marginal Zone L...	tafasitamab rituximab lenalidomide placebo	18 Years -	Incyte Corporation
To Assess the Safety and Tolerability of Tafasitamab Alone or in Combination With Other Drugs in Japanese Participants With Non-Hodgkins Lymphoma (NHL)	NCT04661007	Non Hodgkins Ly... Diffuse Large B...	tafasitamab lenalidomide parsaclisib R-CHOP	18 Years -	Incyte Corporation
Study to Evaluate the Safety and Efficacy of Tafasitamab Plus Lenalidomide in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (firmMIND)	NCT05429268	Large B-Cell Ly... Diffuse Large B...	Tafasitamab Lenalidomide	18 Years - 99 Years	Incyte Corporation

Spots Global Cancer Trial Database for incmor00208

Every month we try and update this database with for incmor00208 cancer trials from around the world to help patients and their families find trials that might be right for them.
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Spots Global Cancer Trial Database for incmor00208

Every month we try and update this database with for incmor00208 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for incmor00208 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.