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

Last updated: December 5, 2024
Sponsor: Incyte Biosciences Japan GK
Overall Status: Active - Recruiting

Phase

1/2

Condition

Lymphoma

Hematologic Cancer

Treatment

lenalidomide

R-CHOP

parsaclisib

Clinical Study ID

NCT04661007
INCMOR 0208-102
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 refractoryDLBCL.

  • Groups 2 and 6 only: Biopsy-proven participants with DLBCL and another selectlymphoid 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 inthe 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 beconsidered potentially unreliable and/or uncooperative.

  2. Be able to understand the reason for complying with the special conditions ofthe pregnancy prevention risk management plan and give written acknowledgementof this.

Exclusion

Exclusion Criteria:

  • Any other histological type of lymphoma.

  • History of prior non-hematologic malignancy.

  • Congestive heart failure requiring use of ongoing maintenance therapy forlife-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 atscreening.

  • Known CNS lymphoma involvement - present or past medical history.

  • History or evidence of clinically significant cardiovascular, CNS and/or othersystemic disease that would in the investigator's opinion preclude participation inthe study or compromise the participant's ability to give informed consent.

  • History or evidence of rare hereditary problems of galactose intolerance, Lapplactase 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 participantis recovered at the time of signing the ICF.

  • Any anticancer and/or investigational therapy within 14 days prior to the start ofCycle 1.

  • Groups 2, 3, 4a, 5 and 6 only: Gastrointestinal abnormalities including theinability to take oral study treatment, requiring IV alimentation, or prior surgicalprocedure affecting absorption.

  • Pregnancy or lactation.

  • Groups 2, 3, 5 and 6 only: Participants who have history of deep venousthrombosis/embolism, threatening thromboembolism, stroke or known thrombophilia orare at a high risk for a thromboembolic event in the opinion of the investigator andwho are not willing/able to take venous thromboembolic event prophylaxis during theentire 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 withinthe 14 days prior to Day 1 dosing.

  2. In the opinion of the investigator, not recovered sufficiently from the adversetoxic 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 inGroups 2 and 6 who have received previous CD19 directed therapy (other thantafasitamab) must have CD19-positive lymphoma confirmed by a biopsy taken aftercompleting the prior CD19-targeted therapy.

  4. Groups 2, 3 and 6 only: Been previously treated with IMiDs (eg, thalidomide orLEN).

  5. Group 4a only: Been previously treated with selective PI3Kδ or pan-PI3Kinhibitors (eg, idelalisib, copanlisib, duvelisib) and/or Bruton's tyrosinekinase inhibitors (eg, ibrutinib).

  6. A history of hypersensitivity to compounds of similar biological or chemicalcomposition to tafasitamab, IMiDs, and/or the excipients contained in the studytreatment formulations (citric acid monohydrate, polysorbate 20, sodium citratedehydrate 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 fullhematological 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 diseasesor 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 tafasitamaband/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 startof Cycle 1, except for permitted prephase treatment defined below.

Study Design

Total Participants: 65
Treatment Group(s): 4
Primary Treatment: lenalidomide
Phase: 1/2
Study Start date:
December 15, 2020
Estimated Completion Date:
July 20, 2026

Connect with a study center

  • Aichi Cancer Center Hospital

    Aichi, 464 8681
    Japan

    Active - Recruiting

  • Chiba Cancer Center

    Chiba, 260-8717
    Japan

    Active - Recruiting

  • National Cancer Center Hospital East

    Chiba, 277-8577
    Japan

    Active - Recruiting

  • University of Fukui Hospital

    Fukui, 910-1193
    Japan

    Active - Recruiting

  • Kyushu University Hospital

    Fukuoka,
    Japan

    Active - Recruiting

  • National Hospital Organization Kyushu Cancer Center

    Fukuoka, 811-1395
    Japan

    Active - Recruiting

  • Kobe City Medical Center General Hospital

    Hyogo, 650-0047
    Japan

    Active - Recruiting

  • Tokai University Hospital

    Isehara, 259-1193
    Japan

    Site Not Available

  • Tokai University Hospital

    Kanagawa, 259-1193
    Japan

    Active - Recruiting

  • Kobe City Medical Center General Hospital

    Kobe, 650-0047
    Japan

    Site Not Available

  • Kobe City Medical Center General Hospital

    Kobe-shi, 650-0047
    Japan

    Site Not Available

  • The Cancer Institute Hospital of Jfcr

    Koto-ku, 135-8550
    Japan

    Active - Recruiting

  • Nho Kumamoto Medical Center

    Kumamoto-ken, 860-008
    Japan

    Active - Recruiting

  • Nho Shikoku Cancer Center

    Matsuyama, 791-0280
    Japan

    Active - Recruiting

  • Tohoku University Hospital

    Miyagi, 980-8574
    Japan

    Active - Recruiting

  • Japanese Red Cross Nagoya Daini Hospital

    Nagoya, 466-8650
    Japan

    Active - Recruiting

  • Iuhw Narita Hospital

    Narita City, 286-8520
    Japan

    Site Not Available

  • Nho Okayama Medical Center

    Okayama, 701-1192
    Japan

    Active - Recruiting

  • Kindai University Hospital

    Osakasayama City, 589-8511
    Japan

    Active - Recruiting

  • Kindai University Hospital

    Osakasayama-shi, 589-8511
    Japan

    Site Not Available

  • Saitama Medical Center

    Saitama-shi, 330-8503
    Japan

    Active - Recruiting

  • Nho Hokkaido Cancer Center

    Sapporo, 003-0804
    Japan

    Active - Recruiting

  • Tohoku University Hospital

    Sendai-shi, 908-8574
    Japan

    Site Not Available

  • Osaka University Hospital

    Suita-shi, 565-0871
    Japan

    Active - Recruiting

  • Mie University Hospital

    TSU, 514-0001
    Japan

    Active - Recruiting

  • Nho Disaster Medical Center

    Tachikawa, 190-0014
    Japan

    Active - Recruiting

  • National Cancer Center Hospital

    Tokyo, 104-0045
    Japan

    Active - Recruiting

  • Nho Disaster Medical Center

    Tokyo, 190-0014
    Japan

    Site Not Available

  • Kanagawa Cancer Center

    Yokohama-shi, 241-8515
    Japan

    Active - Recruiting

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