Phase
Condition
Lymphoma
Hematologic Cancer
Treatment
lenalidomide
R-CHOP
parsaclisib
Clinical Study ID
Ages > 18 All Genders
Study Summary
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:
Untreated DLBCL.
Ann Arbor Stage III to IV.
IPI status of 3 to 5 or age-adjusted IPI 2-3 (in Group 5 only).
Appropriate candidate for R-CHOP.
LVEF of ≥ 50%, assessed by echocardiography.
Willingness to avoid pregnancy or fathering children.
In the opinion of investigator, the participant must:
Not have a history of noncompliance in relation to medical regimens or beconsidered potentially unreliable and/or uncooperative.
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:
Not discontinued CD20-targeted therapy, chemotherapy, radiotherapy,investigational anticancer therapy, or other lymphoma-specific therapy withinthe 14 days prior to Day 1 dosing.
In the opinion of the investigator, not recovered sufficiently from the adversetoxic effects of prior therapies.
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.
Groups 2, 3 and 6 only: Been previously treated with IMiDs (eg, thalidomide orLEN).
Group 4a only: Been previously treated with selective PI3Kδ or pan-PI3Kinhibitors (eg, idelalisib, copanlisib, duvelisib) and/or Bruton's tyrosinekinase inhibitors (eg, ibrutinib).
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).
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.
Undergone previous allogenic stem cell transplantation.
Concurrent treatment other anticancer or experimental treatments.
- Group 5 only: Participants who have:
A history of radiation therapy to ≥ 25% of the bone marrow for other diseasesor history of anthracycline therapy.
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.
Contraindication to any of the individual components of R-CHOP.
Any anticancer and/or investigational therapy within 30 days prior to the startof Cycle 1, except for permitted prephase treatment defined below.
Study Design
Connect with a study center
Aichi Cancer Center Hospital
Aichi, 464 8681
JapanActive - Recruiting
Chiba Cancer Center
Chiba, 260-8717
JapanActive - Recruiting
National Cancer Center Hospital East
Chiba, 277-8577
JapanActive - Recruiting
University of Fukui Hospital
Fukui, 910-1193
JapanActive - Recruiting
Kyushu University Hospital
Fukuoka,
JapanActive - Recruiting
National Hospital Organization Kyushu Cancer Center
Fukuoka, 811-1395
JapanActive - Recruiting
Kobe City Medical Center General Hospital
Hyogo, 650-0047
JapanActive - Recruiting
Tokai University Hospital
Isehara, 259-1193
JapanSite Not Available
Tokai University Hospital
Kanagawa, 259-1193
JapanActive - Recruiting
Kobe City Medical Center General Hospital
Kobe, 650-0047
JapanSite Not Available
Kobe City Medical Center General Hospital
Kobe-shi, 650-0047
JapanSite Not Available
The Cancer Institute Hospital of Jfcr
Koto-ku, 135-8550
JapanActive - Recruiting
Nho Kumamoto Medical Center
Kumamoto-ken, 860-008
JapanActive - Recruiting
Nho Shikoku Cancer Center
Matsuyama, 791-0280
JapanActive - Recruiting
Tohoku University Hospital
Miyagi, 980-8574
JapanActive - Recruiting
Japanese Red Cross Nagoya Daini Hospital
Nagoya, 466-8650
JapanActive - Recruiting
Iuhw Narita Hospital
Narita City, 286-8520
JapanSite Not Available
Nho Okayama Medical Center
Okayama, 701-1192
JapanActive - Recruiting
Kindai University Hospital
Osakasayama City, 589-8511
JapanActive - Recruiting
Kindai University Hospital
Osakasayama-shi, 589-8511
JapanSite Not Available
Saitama Medical Center
Saitama-shi, 330-8503
JapanActive - Recruiting
Nho Hokkaido Cancer Center
Sapporo, 003-0804
JapanActive - Recruiting
Tohoku University Hospital
Sendai-shi, 908-8574
JapanSite Not Available
Osaka University Hospital
Suita-shi, 565-0871
JapanActive - Recruiting
Mie University Hospital
TSU, 514-0001
JapanActive - Recruiting
Nho Disaster Medical Center
Tachikawa, 190-0014
JapanActive - Recruiting
National Cancer Center Hospital
Tokyo, 104-0045
JapanActive - Recruiting
Nho Disaster Medical Center
Tokyo, 190-0014
JapanSite Not Available
Kanagawa Cancer Center
Yokohama-shi, 241-8515
JapanActive - Recruiting
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