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New drug combo shows promise for blood cancer patients

NCT ID NCT04277637

Disease control Sponsor: BeOne Medicines Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 early-phase study tests a new drug called BGB-11417 (sonrotoclax) in people with B-cell blood cancers that have come back or not responded to treatment. The goal is to find the safest dose and see how well it works alone or combined with other drugs. About 437 adults will take part, and the study focuses on side effects and the best dose for future trials.

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

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

437 people

The number who actually took part.

Started

Mar 2020

Expected to finish

May 2027

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.

Key Inclusion Criteria: * Confirmed diagnosis of one of the following: NHL Cohorts: 1. MZL i. R/R extranodal, splenic, or nodal MZL defined as disease that relapsed after, or was refractory to, at least one prior therapy ii. Active disease requiring treatment 2. FL i. R/R FL (Grade 1, 2 or 3a based on the WHO 2008 classification of tumors of hematopoietic and lymphoid tissue) and defined as disease that relapsed after, or was refractory to, at least 1 prior systemic therapy 3. DLBCL i. R/R DLBCL (including all subtypes of DLBCL) defined as disease that relapsed after, or was refractory to, at least two prior systemic therapies and has either progressed following or is not a candidate for autologous stem cell transplant (due to comorbidities or non-responsiveness to salvage chemotherapy) 4. Transformed indolent B-cell NHL i. Any lymphoma otherwise eligible for Part 1 that has transformed into a more aggressive lymphoma. Patients with transformation from CLL or SLL (Richter's transformation) are not eligible for Part 1 CLL/SLL Cohorts: 5. CLL/SLL diagnosis that meets the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria i. Disease characterized as Treatment Naive (TN) or R/R disease defined as disease that relapsed after, or was refractory to, at least 1 prior therapy ii. Requiring treatment as defined by history MCL cohorts: 6. WHO-defined MCL i. R/R MCL defined as disease that relapsed after, or was refractory to, at least 1 prior systemic therapy; ii. Requiring treatment in the opinion of the investigator WM cohorts: g. WHO-defined WM (clinical and definitive histologic diagnosis) i. R/R disease defined as disease that relapsed after, or was refractory to, at least 1 prior therapy; ii. Meeting at least 1 criterion for treatment according to consensus panel criteria from the Seventh International Workshop on Waldenström's Macroglobulinemia (Dimopoulos et al 2014) * Measurable disease by computed tomography (CT)/magnetic resonance imaging (MRI), defined as: 1. CLL: at least 1 lymph node \> 1.5 cm in longest diameter and measurable in 2 perpendicular dimensions or clonal lymphocytes measured by flow cytometry 2. DLBCL, FL, MZL, MCL, or SLL: at least 1 lymph node \> 1.5 cm in longest diameter OR 1 extranodal lesion \> 1.0 cm in the longest diameter, measurable in at least 2 perpendicular dimensions. For MZL, isolated splenomegaly is considered measurable for this study 3. WM: serum immunoglobulin (Ig) M level \> 0.5 g/dL * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 * Adequate organ function * Adequate pancreatic function indicated by: 1. Serum amylase ≤ 1.5 x upper limit of normal (ULN) 2. Serum lipase ≤ 1.5 x ULN Key Exclusion Criteria: * Known current central nervous system involvement by lymphoma/leukemia * Known plasma cell neoplasm, prolymphocytic leukemia, history of or currently suspected Richter's syndrome * Prior therapy ≥ 2 months with or progression on a B-cell lymphoma-2 (Bcl-2) inhibitor NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

B-cell chronic lymphocytic leukemia diffuse large B-cell lymphoma follicular lymphoma indolent B-cell non-Hodgkin lymphoma mantle cell lymphoma marginal zone lymphoma neoplasm of mature B-cells Waldenstrom macroglobulinemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Mature B-cell malignancies

Contacts and locations

Locations

  • Auckland City Hospital

    Auckland, 1023, New Zealand

  • Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

    Milan, 20162, Italy

  • Azienda Unita Sanitaria Locale Di Ravenna

    Ravenna, 48121, Italy

  • Box Hill Hospital

    Box Hill, Victoria, VIC 3128, Australia

  • Centroricerche Cliniche Di Verona Srl

    Verona, 37134, Italy

  • Columbia University Medical Center

    New York, New York, 10032, United States

  • Concord Repatriation General Hospital

    Concord, New South Wales, NSW 2139, Australia

  • Flinders Medical Centre

    Bedford PK, South Australia, SA 5042, Australia

  • Fondazione Policlinico Universitario Agostino Gemelli

    Roma, 00168, Italy

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98109-4433, United States

  • Hospital Clinic de Barcelona

    Barcelona, 08036, Spain

  • Hospital Universitario Marques de Valdecilla

    Santander, 39008, Spain

  • Hospital Universitario de Salamanca

    Salamanca, 37007, Spain

  • Hospital de La Santa Creu I Sant Pau

    Barcelona, 08041, Spain

  • Ico H Duran I Reynals

    Barcelona, 08907, Spain

  • John Flynn Private Hospital

    Tugun, Queensland, QLD 4224, Australia

  • John Theurer Cancer Center Hackensack University Medical Center

    Hackensack, New Jersey, 07601, United States

  • Linear Clinical Research

    Nedlands, Western Australia, WA 6009, Australia

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic Rochester

    Rochester, Minnesota, 55905-0001, United States

  • Md Anderson Cancer Center

    Houston, Texas, 77030-3907, United States

  • Memorial Sloan Kettering Cancer Center Mskcc

    New York, New York, 10065-6800, United States

  • Monash Health

    Clayton, Victoria, VIC 3168, Australia

  • North Shore Hospital

    Auckland, 0622, New Zealand

  • Northwestern University

    Chicago, Illinois, 60611, United States

  • Orange Health Service (Central West Cancer Care Centre)

    Orange, New South Wales, NSW 2800, Australia

  • Ospedale San Raffaele

    Milan, 20132, Italy

  • Ospedale Santa Maria Della Misericordia

    Perugia, 6129, Italy

  • Peter Maccallum Cancer Centre

    Melbourne, Victoria, VIC 3000, Australia

  • Pindara Private Hospital

    Benowa, Queensland, QLD 4217, Australia

  • Royal Adelaide Hospital

    Adelaide, South Australia, SA 5000, Australia

  • St Vincents Hospital Melbourne

    Fitzroy, Victoria, VIC 3065, Australia

  • Start Madrid Fundacion Jimenez Diaz

    Madrid, 28040, Spain

  • The Alfred Hospital

    Melbourne, Victoria, VIC 3004, Australia

  • The James Cancer Hospital and Solove Research Institute At Ohio State University

    Columbus, Ohio, 43210-1240, United States

  • The Leeds Teaching Hospitals Nhs Trust

    Leeds, LS9 7TF, United Kingdom

  • UCLA Hematologyoncology

    Los Angeles, California, 90095-3075, United States

  • Universitatsklinikum Carl Gustav Carus An Der Technischen Universitat Dresden

    Dresden, 01307, Germany

  • University of Kansas Medical Center Research Institute

    Kansas City, Kansas, 66160-8500, United States

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198, United States

  • Upmc Hillman Cancer Center(Univ of Pittsburgh)

    Pittsburgh, Pennsylvania, 15232-1309, United States

  • Vall D Hebron Institute of Oncology Vhio

    Barcelona, 08035, Spain

  • Wellington Regional Hospital (Ccdhb)

    Wellington, 6021, New Zealand

More trials for these conditions

Other studies related to the condition(s) this trial covers.