New drug combo shows promise against blood cancer in japanese trial
NCT ID NCT04661007
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests the safety and effectiveness of tafasitamab, given alone or with other drugs (lenalidomide, parsaclisib, or R-CHOP), in about 72 Japanese adults with Non-Hodgkin lymphoma. The goal is to find the best doses and see if the treatment shrinks tumors. Participants have either relapsed/refractory or newly diagnosed disease.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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72 people
The number who actually took part.
- Started
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Dec 2020
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Aichi Cancer Center Hospital
Aichi, 464 8681, Japan
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Chiba Cancer Center
Chiba, 260-8717, Japan
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Iuhw Narita Hospital
Narita, 286-8520, Japan
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Japanese Red Cross Nagoya Daini Hospital
Nagoya, 466-8650, Japan
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Kanagawa Cancer Center
Yokohama, 241-8515, Japan
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Kindai University Hospital
Sayama, 589-8511, Japan
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Kobe City Medical Center General Hospital
Hyōgo, 650-0047, Japan
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Kyushu University Hospital
Fukuoka, Japan
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Mie University Hospital
Tsu, 514-0001, Japan
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National Cancer Center Hospital
Tokyo, 104-0045, Japan
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National Cancer Center Hospital East
Chiba, 277-8577, Japan
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National Hospital Organization Kyushu Cancer Center
Fukuoka, 811-1395, Japan
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Nho Disaster Medical Center
Tachikawa, 190-0014, Japan
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Nho Hokkaido Cancer Center
Sapporo, 003-0804, Japan
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Nho Kumamoto Medical Center
Kumamoto-ken, 860-008, Japan
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Nho Okayama Medical Center
Okayama, 701-1192, Japan
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Nho Shikoku Cancer Center
Matsuyama, 791-0280, Japan
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Osaka University Hospital
Suita-shi, 565-0871, Japan
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Saitama Medical Center
Saitama-shi, 330-8503, Japan
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The Cancer Institute Hospital of Jfcr
Kōtoku, 135-8550, Japan
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Tohoku University Hospital
Miyagi, 980-8574, Japan
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Tokai University Hospital
Kanagawa, 259-1193, Japan
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University of Fukui Hospital
Fukui, 910-1193, Japan
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