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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) (topMIND)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04809467
Recruitment Status : Active, not recruiting
First Posted : March 22, 2021
Last Update Posted : September 22, 2022
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Chronic Lymphocytic Leukemia Non Hodgkin Lymphoma Drug: tafasitamab Drug: parsaclisib Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: Open Label
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : September 16, 2021
Estimated Primary Completion Date : October 31, 2023
Estimated Study Completion Date : October 31, 2023


Arm Intervention/treatment
Experimental: tafasitamab + parsaclisib

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

Drug: tafasitamab
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.
Other Name: INCMOR00208

Drug: parsaclisib
parsaclisib will be administered at protocol defined dose for cycles 1 through disease progression.
Other Name: INCB050465




Primary Outcome Measures :
  1. Phase 1b : Number of Treatment Emergent Adverse Events [ Time Frame: Up to 25 months ]
    Any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug.

  2. Phase 1b : Incidence of Dose Limiting Toxicities [ Time Frame: 28 Days ]
    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.


Secondary Outcome Measures :
  1. Phase 2a : Overall Response Rate [ Time Frame: Up to 25 months ]
    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.

  2. Pharmacokinetics Parameter : Cmax of tafasitamab [ Time Frame: Up to 24 months ]
    Maximum Observed Plasma Concentration of tafasitamab

  3. Pharmacokinetics Parameter : Cmin of tafasitamab [ Time Frame: Up to 24 months ]
    Minimum Observed Plasma Concentration of tafasitamab

  4. Pharmacokinetics Parameter : Tmax of tafasitamab [ Time Frame: Up to 24 months ]
    Time to reach maximum plasma concentration of tafasitamab

  5. Pharmacokinetics Parameter : AUC(t) of tafasitamab [ Time Frame: Up to 24 months ]
    Area under the concentration-time curve from time zero to time of tafasitamab

  6. Pharmacokinetics Parameter : Ctrough of tafasitamab [ Time Frame: Up to 24 months ]
    C trough concentration of tafasitamab



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed R/R B-cell malignancy: DLBCL (THRLBCL, EBV-positive DLBCL of the elderly, Grade 3b FL, HGBL with MYC and BCL2 and/or BCL6 rearrangements, transformed lymphoma); MCL ((with cyclin D1 overexpression or t(11;14); FL (Grade 1, 2, 3a); MZL (extranodal, nodal, splenic) ; CLL, or SLL
  • Willingness to undergo biopsy
  • At least 2 prior systemic treatment regimens, including prior treatment with an anti-CD20 antibody (all cohorts) or prior treatment with a BTK inhibitor (CLL/SLL)
  • Relapsed, progressive, or refractory NHL or CLL
  • For NHL/SLL: Radiographically measurable nodal or extranodal disease (all cohorts except CLL)
  • ECOG-PS 0 - 2
  • LVEF ≥ 50%
  • Adequate renal, hepatic, bone marrow function

Exclusion Criteria:

  • Any other histological type of lymphoma
  • Primary or secondary CNS lymphoma
  • Anticancer and/or investigational therapy within the past 30 days or 5 half-lives
  • Allogeneic stem cell transplantation within the past 6 months, or ASCT within 3 months before C1D1
  • Previous treatment with CD19-targeted therapy or PI3K inhibitors
  • Clinically significant cardiac disease
  • Other malignancy within the past 3 years
  • Active graft-versus-host disease
  • Stroke or intracranial hemorrhage within the past 6 months
  • Chronic or current active infectious disease
  • Positive virus serology for HCV, HBV, HIV
  • Currently pregnant or breastfeeding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04809467


Locations
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Sponsors and Collaborators
Incyte Corporation
Investigators
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Study Director: Oliver Manzke, MD Incyte Corporation
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Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT04809467    
Other Study ID Numbers: INCMOR 0208-101
First Posted: March 22, 2021    Key Record Dates
Last Update Posted: September 22, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

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

Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
Access Criteria: Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.
URL: https://www.incyte.com/our-company/compliance-and-transparency

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Incyte Corporation:
Relapsed or Refractory
Leukemia
tafasitamab
parsaclisib
MOR00208
INCMOR00208
Additional relevant MeSH terms:
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Lymphoma
Leukemia
Lymphoma, Non-Hodgkin
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell