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

Launched by INCYTE BIOSCIENCES JAPAN GK · Dec 8, 2020

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment called tafasitamab for people with Non-Hodgkin's Lymphoma, specifically a type called Diffuse Large B-cell Lymphoma. The study aims to see how safe and tolerable tafasitamab is when used alone or in combination with other medications. It is open to Japanese participants aged 65 and older who have certain types of lymphoma that have not responded to previous treatments or who have not yet been treated. To be eligible, participants must have a measurable tumor and have received at least one prior therapy that included a specific type of treatment targeting lymphoma cells.

Participants in the trial can expect to receive tafasitamab either by itself or along with other medications. The study will monitor their health closely to ensure the treatment is safe. It’s important to note that participants will need to meet specific health criteria to join the trial, and those with certain health conditions or who are pregnant or breastfeeding will not be able to participate. This trial is currently recruiting participants, and if you're interested, it may be a good idea to talk to your doctor about it.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Group 1 only: Biopsy-proven participants with relapsed or refractory NHL of DLBCL, FL or MZL.
• • Groups 3, 4a and 5 only: Biopsy-proven participants with relapsed or refractory DLBCL.
• • Groups 2 and 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 as defined in the protocol.
• * Group 1 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 2, 3, 4a and 6 only:
• • 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:
• • 1. Untreated DLBCL.
• • 2. Ann Arbor Stage III to IV.
• • 3. IPI status of 3 to 5 or age-adjusted IPI 2-3 (in Group 5 only).
• • 4. Appropriate candidate for R-CHOP.
• • 5. LVEF of ≥ 50%, assessed by echocardiography.
• • Willingness to avoid pregnancy or fathering children.
• * In the opinion of investigator, the participant must:
• • 1. Not have a history of noncompliance in relation to medical regimens or be considered potentially unreliable and/or uncooperative.
• • 2. 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.
• • 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 2, 3, 4a, 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 2, 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
• • Group 4a 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, 3, 4a and 6 only: Participants who have:
• • 1. Not discontinued CD20-targeted therapy, chemotherapy, radiotherapy, investigational anticancer therapy, or other lymphoma-specific therapy within the 14 days prior to Day 1 dosing.
• • 2. In the opinion of the investigator, not recovered sufficiently from the adverse toxic effects of prior therapies.
• • 3. Groups 1, 3 and 4a only: Previous treatment with CD19-targeted therapy (eg, CD19-CAR-T therapies, other CD19 mAbs including bispecific and ADCs).
• • Groups 2 and 6 only: Previous treatment with tafasitamab. Note: Participants in Groups 2 and 6 who have received previous CD19 directed therapy (other than tafasitamab) must have CD19-positive lymphoma confirmed by a biopsy taken after completing the prior CD19-targeted therapy.
• • 4. Groups 2, 3 and 6 only: Been previously treated with IMiDs (eg, thalidomide or LEN).
• • 5. Group 4a only: Been previously treated with selective PI3Kδ or pan-PI3K inhibitors (eg, idelalisib, copanlisib, duvelisib) and/or Bruton's tyrosine kinase inhibitors (eg, ibrutinib).
• • 6. 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).
• • 7. 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.
• • 8. Undergone previous allogenic stem cell transplantation.
• • 9. Concurrent treatment other anticancer or experimental treatments.
• * Group 5 only: Participants who have:
• • 1. A history of radiation therapy to ≥ 25% of the bone marrow for other diseases or history of anthracycline therapy.
• • 2. 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.
• • 3. Contraindication to any of the individual components of R-CHOP.
• • 4. Any anticancer and/or investigational therapy within 30 days prior to the start of Cycle 1, except for permitted prephase treatment defined below.