- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04661007
To Assess the Safety and Tolerability of Tafasitamab Alone or in Combination With Other Drugs in Japanese Participants With Non-Hodgkins Lymphoma (NHL) (J-MIND)
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
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Incyte Biosciences Japan GK Development Operations Call Center
- Phone Number: +81 3-3507-5795
- Email: japan_clinicaltrials@incyte.com
Study Locations
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Aichi, Japan, 464 8681
- Recruiting
- Aichi Cancer Center Hospital
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Chiba, Japan, 277-8577
- Recruiting
- National Cancer Center Hospital East
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Chiba, Japan, 260-8717
- Recruiting
- Chiba cancer center
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Fukui, Japan, 910-1193
- Recruiting
- University of Fukui Hospital
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Fukuoka, Japan
- Recruiting
- Kyushu University Hospital
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Fukuoka, Japan, 811-1395
- Recruiting
- National Hospital Organization Kyushu Cancer Center
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Isehara, Japan, 259-1193
- Not yet recruiting
- Tokai University Hospital
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Kobe, Japan, 650-0047
- Recruiting
- Kobe City Medical Center General Hospital
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Koto-ku, Japan, 135-8550
- Recruiting
- The Cancer Institute Hospital of JFCR
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Kumamoto-ken, Japan, 860-008
- Recruiting
- Nho Kumamoto Medical Center
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Matsuyama, Japan, 791-0280
- Recruiting
- NHO Shikoku Cancer Center
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Nagoya, Japan, 466-8650
- Recruiting
- Japanese Red Cross Nagoya Daini Hospital
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Okayama, Japan, 701-1192
- Recruiting
- Nho Okayama Medical Center
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Osakasayama City, Japan, 589-8511
- Recruiting
- Kindai University Hospital
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Saitama-shi, Japan, 330-8503
- Recruiting
- Saitama Medical Center
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Sapporo, Japan, 003-0804
- Recruiting
- NHO Hokkaido Cancer Center
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Sendai-shi, Japan, 908-8574
- Recruiting
- Tohoku University Hospital
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Suita-shi, Japan, 565-0871
- Recruiting
- Osaka University Hospital
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TSU, Japan, 514-0001
- Recruiting
- Mie University Hospital
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Tokyo, Japan, 104-0045
- Recruiting
- National Cancer Center Hospital
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Tokyo, Japan, 190-0014
- Not yet recruiting
- Nho Disaster Medical Center
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Yokohama-shi, Japan, 241-8515
- Recruiting
- Kanagawa cancer center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Groups 1 and 2 only: Biopsy-proven participants with relapsed or refractory NHL of DLBCL, FL or MZL..
- Groups 3, and 4 only: Biopsy-proven participants with relapsed or refractory DLBCL.
- Groups 5 only: Biopsy-proven participants with relapsed or refractory DLBCL..
- Group 6 only: Biopsy-proven participants with DLBCL and another select lymphoid neoplasms.
- Participants must have at least 1 bi-dimensionally measurable lesion.
- -ECOG performance status of 0 to 2.
- Participants with protocol defined laboratory criteria at screening
- Groups 1 and 2 only:
Received at least 1 previous systemic therapy line for the treatment of NHL. At least 1 previous therapy line must have included a CD20-targeted therapy (eg, RTX).
-Groups 3, 4a, and 4b and 6only: Received at least 1, but no more than 3, previous systemic therapy lines for the treatment of DLBCL. At least 1 previous therapy line must have included a CD20-targeted therapy (eg, RTX).
- Group 5 only: Participants must have: a. Untreated DLBCL. b. Ann Arbor Stage III to IV. c. IPI status of 3 to 5 or age-adjusted IPI 2-3 (in Group 5 only). d. Appropriate candidate for R-CHOP. e. LVEF of ≥ 50%, assessed by echocardiography.
-Willingness to avoid pregnancy or fathering children.
-In the opinion of investigator, the participant must: a. Not have a history of noncompliance in relation to medical regimens or be considered potentially unreliable and/or uncooperative.
b. Be able to understand the reason for complying with the special conditions of the pregnancy prevention risk management plan and give written acknowledgement of this.
Exclusion Criteria:
-Any other histological type of lymphoma
- Group 6 only: Primary refractory DLBCL
- History of prior non-hematologic malignancy
- Congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias.
- Participants with known positive test result for hepatitis C, and hepatitis B.
- Known seropositive for or history of active viral infection with HIV.
- Known active bacterial, viral, fungal, mycobacterial, or other infection at screening.
- Known CNS lymphoma involvement - present or past medical history.
- History or evidence of clinically significant cardiovascular, CNS and/or other systemic disease that would in the investigator's opinion preclude participation in the study or compromise the participant's ability to give informed consent.
- History or evidence of rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
- History or evidence of interstitial lung disease.
- Vaccination with live vaccine within 21 days prior to study treatment (Note: throughout the study treatment period and at least 6 months after end of treatment, vaccination with live vaccines should be avoided).
- Major surgery within up to 30 days prior to signing the ICF, unless the participant is recovered at the time of signing the ICF.
- Any anticancer and/or investigational therapy within 14 days prior to the start of Cycle 1
- Groups 3, 4a, 4b, 5 and 6 only: Gastrointestinal abnormalities including the inability to take oral study treatment, requiring IV alimentation, or prior surgical procedure affecting absorption.
- Pregnancy or lactation.
- Groups 3, 5 and 6 only: Participants who have history of deep venous thrombosis/embolism, threatening thromboembolism, stroke or known thrombophilia or are at a high risk for a thromboembolic event in the opinion of the investigator and who are not willing/able to take venous thromboembolic event prophylaxis during the entire treatment period if required
- Groups 4a and 4b only: Use or expected use during the study of any restricted medications, including potent CYP3A4 inhibitors or inducers within 14 days or 5 half-lives (whichever is longer) before the date of study treatment administration
Groups 1, 2, 3, 4a, and 4b only: Participants who have: a. Not discontinued CD20-targeted therapy, chemotherapy, radiotherapy, investigational anticancer therapy, or other lymphoma-specific therapy within the 14 days prior to Day 1 dosing.
b. In the opinion of the investigator, not recovered sufficiently from the adverse toxic effects of prior therapies.
c. Previous treatment with CD19-targeted therapy (eg, CD19-CAR-T therapies, other CD19 mAbs including bispecific and ADCs).
d. Group 3 only: Been previously treated with IMiDs (eg, thalidomide or LEN). e. Group 4a and 4b only: Been previously treated with selective PI3Kδ or pan-PI3K inhibitors (eg, idelalisib, copanlisib, duvelisib) and/or Bruton's tyrosine kinase inhibitors (eg, ibrutinib).
f. A history of hypersensitivity to compounds of similar biological or chemical composition to tafasitamab, IMiDs, and/or the excipients contained in the study treatment formulations (citric acid monohydrate, polysorbate 20, sodium citrate dehydrate and trehalose dihydrate).
g. Undergone ASCT within the period ≤ 3 months before the signing of the ICF. Participants who have a more distant history of ASCT must exhibit full hematological recovery before enrolment into the study.
h. Undergone previous allogenic stem cell transplantation. i. Concurrent treatment other anticancer or experimental treatments.
Group 5 only: Participants who have: a. A history of radiation therapy to ≥ 25% of the bone marrow for other diseases or history of anthracycline therapy.
b. A history of hypersensitivity or contraindication to any component of R-CHOP, LEN, or compounds of similar biological or chemical composition as tafasitamab and/or the excipients contained in the study treatment formulations or R-CHOP.
c. Contraindication to any of the individual components of R-CHOP. d. Any anticancer and/or investigational therapy within 30 days prior to the start of Cycle 1, except for permitted prephase treatment defined below.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Part 1 : tafasitimab monotherapy
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 2 groups: Group 1 will evaluate weight-based doses of tafasitamab, and Group 2 will evaluate fixed doses of tafasitamab.
|
tafasitamab will be administered at protocol defined timepoints based on the groups participants are assigned.
Other Names:
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Experimental: Part 2 : tafasitamab combination therapy
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.
The dose of tafasitamab will be based on the weight-based RP2D that is deemed safe and tolerable in Part 1.
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tafasitamab will be administered at protocol defined timepoints based on the groups participants are assigned.
Other Names:
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.
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Experimental: Part 3 : Dose Expansion of tafasitamab +parsaclisib
tafasitamab in combination with parsaclisib will be further evaluated in Group 4b at RP2D determined in Part 2
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tafasitamab will be administered at protocol defined timepoints based on the groups participants are assigned.
Other Names:
parsaclisib will be administered at protocol defined timepoints based on the groups participants are assigned.
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Experimental: Part 4: tafasitamab combination therapy
tafasitamiab in combination with lenalidomide will be further evaluated in Group 6 at RP2D determined in Part 2.
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tafasitamab will be administered at protocol defined timepoints based on the groups participants are assigned.
Other Names:
lenalidomide will be administered orally at protocol defined timepoints based on the groups participants are assigned.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Part 1,2 and 3 : Treatment Emergent Adverse Events (TEAE'S)
Time Frame: Approximately 2 years
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Adverse events reported for the first time or worsening of a pre-existing event after first dose of study treatment.
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Approximately 2 years
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Part 4: Objective Response
Time Frame: Approximately 27 months
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Best Response of complete/complete metabolic response or partial/partial metabolic response
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Approximately 27 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Part 1,2, 3 and 4 : Cmax of tafasitamab
Time Frame: Approximately 27 months
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Maximum observed serum concentration.
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Approximately 27 months
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Part 1, 2, 3 and 4: Cmin of tafasitamab
Time Frame: Approximately 27 months
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Minimum observed serum concentration over the dose interval.
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Approximately 27 months
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Part 4: Complete Response
Time Frame: Approximately 27 months
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Defined as the proportion of participants with Complete Response as determined by an IRC and investigator assessment according to the Lugano criteria
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Approximately 27 months
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Part 4: Duration of Response
Time Frame: Approximately 27 months
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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
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Approximately 27 months
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Part 4: Progression-Free Survival
Time Frame: Approximately 27 months
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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.
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Approximately 27 months
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Part 4: Overall Survival
Time Frame: Approximately 27 months
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Defined as the time from the date of randomization until death from any cause.
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Approximately 27 months
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Part 4: Overall Response Rate
Time Frame: Approximately 27 months
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Defined as the proportion of participants with a CR or PR as determined by the investigator based on the Lugano criteria for response assessment
|
Approximately 27 months
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Part 4: Treatment Emergent Adverse Events (TEAE'S)
Time Frame: Approximately 2 years
|
Adverse events reported for the first time or worsening of a pre-existing event after first dose of study treatment.
|
Approximately 2 years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma, B-Cell
- Lymphoma
- Lymphoma, Large B-Cell, Diffuse
- Lymphoma, Non-Hodgkin
- Physiological Effects of Drugs
- Antineoplastic Agents
- Immunologic Factors
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Lenalidomide
Other Study ID Numbers
- INCMOR 0208-102
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD 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
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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