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New drug combo shows promise against blood cancer in japanese trial

NCT ID NCT04661007

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

72 people

The number who actually took part.

Started

Dec 2020

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

  • Aichi Cancer Center Hospital

    Aichi, 464 8681, Japan

  • Chiba Cancer Center

    Chiba, 260-8717, Japan

  • Iuhw Narita Hospital

    Narita, 286-8520, Japan

  • Japanese Red Cross Nagoya Daini Hospital

    Nagoya, 466-8650, Japan

  • Kanagawa Cancer Center

    Yokohama, 241-8515, Japan

  • Kindai University Hospital

    Sayama, 589-8511, Japan

  • Kobe City Medical Center General Hospital

    Hyōgo, 650-0047, Japan

  • Kyushu University Hospital

    Fukuoka, Japan

  • Mie University Hospital

    Tsu, 514-0001, Japan

  • National Cancer Center Hospital

    Tokyo, 104-0045, Japan

  • National Cancer Center Hospital East

    Chiba, 277-8577, Japan

  • National Hospital Organization Kyushu Cancer Center

    Fukuoka, 811-1395, Japan

  • Nho Disaster Medical Center

    Tachikawa, 190-0014, Japan

  • Nho Hokkaido Cancer Center

    Sapporo, 003-0804, Japan

  • Nho Kumamoto Medical Center

    Kumamoto-ken, 860-008, Japan

  • Nho Okayama Medical Center

    Okayama, 701-1192, Japan

  • Nho Shikoku Cancer Center

    Matsuyama, 791-0280, Japan

  • Osaka University Hospital

    Suita-shi, 565-0871, Japan

  • Saitama Medical Center

    Saitama-shi, 330-8503, Japan

  • The Cancer Institute Hospital of Jfcr

    Kōtoku, 135-8550, Japan

  • Tohoku University Hospital

    Miyagi, 980-8574, Japan

  • Tokai University Hospital

    Kanagawa, 259-1193, Japan

  • University of Fukui Hospital

    Fukui, 910-1193, Japan

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