Clinical Trials in South Korea / NCT07634471
Recruiting
Phase 2/3
A Clinical Trial of MK-1045 and Rituximab in People With Follicular Lymphoma (MK-1045-007)
NCT07634471 · tracked via the Priya Life Science South Korea tracker
Condition(s) studied
Follicular Lymphoma
Investigational drug(s) / intervention(s)
MK-1045 →Rituximab →Rituximab biosimilar →Bendamustine →Cyclophosphamide →Vincristine →Prednisone →Prednisolone →Doxorubicin Hydrochloride →
MK-1045: Intravenous (IV) infusion
Rituximab: IV infusion
Rituximab biosimilar: IV infusion
Bendamustine: IV infusion
Cyclophosphamide: IV infusion
Vincristine: IV infusion
Prednisone: Per approved product label
Prednisolone: Per approved product label
Doxorubicin Hydrochloride: IV infusion
Study summary
Researchers are looking for new ways to treat follicular lymphoma (FL). A standard (usual) treatment for FL includes a targeted therapy called rituximab and chemotherapy. In this study, researchers want to learn if giving a study medicine called MK-1045 and rituximab can treat FL. MK-1045 is a type of treatment called immunotherapy.
The goals of this study are to learn:
* About the safety of MK-1045 and rituximab, and if people tolerate them when given together
* If people who receive MK-1045 and rituximab have the cancer go away
* If people who receive MK-1045 and rituximab live longer without their cancer getting worse compared to those who receive standard treatment (rituximab and chemotherapy)
Eligibility
Inclusion Criteria:
* Has biopsy-proven, previously untreated, histologically confirmed cluster of differentiation (CD)19-positive and CD20-positive classical follicular lymphoma (FL), with Ann Arbor Stage II-IV disease and a Follicular Lymphoma International Prognostic Index (FLIPI) score of 2-5.
* Has radiographically measurable disease per the Lugano Response Criteria.
* Has provided a newly obtained core or excisional biopsy or archival tissue of a tumor lesion not previously irradiated.
* If human immunodeficiency virus (HIV)-positive, has well-controlled HIV on antiretroviral therapy (ART).
* If hepatitis B surface antigen (HBsAg)-positive, has undetectable hepatitis B virus (HBV) viral load and has received HBV antiviral therapy for at least 4 weeks and will continue it.
* If history of hepatitis C virus (HCV) infection, has undetectable HCV viral load.
Exclusion Criteria:
* Has received prior systemic anticancer therapy or radiotherapy for FL.
* Has follicular large B-cell lymphoma or any other subtype of FL other than classical FL.
* Has FL that has transformed into a more aggressive type of lymphoma.
* History or presence of clinically relevant central nervous system (CNS) diseases.
* Has history of serious cardiovascular and cerebrovascular diseases.
* Is HIV-infected with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
* Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention.
* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy.
* Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
* Has known active CNS lymphoma or involvement.
* Has an active autoimmune disease that has required systemic treatment in the past 2 years.
* Has active infection requiring systemic therapy.
* Has chronic liver disease, including liver cirrhosis of Child-Pugh class B or C.
* Has not adequately recovered from major surgery or has ongoing surgical complications.
Primary outcome measure(s)
- Part 1: Number of Participants Who Experience an Adverse Event (AE) — Up to approximately 15 months
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. - Part 1: Number of Participants Who Discontinue Study Treatment Due to an AE — Up to approximately 12 months
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. - Part 1: Number of Participants Who Experience Dose Limiting Toxicity (DLT) — Up to approximately 36 days
DLT will be defined as any drug-related AE observed during the DLT evaluation period that results in a change to a given dose or a delay in initiating the next cycle. - Part 1: Complete Response (CR) Rate — Up to approximately 60 months
For participants who demonstrate a confirmed Complete Response (CR: disappearance of all target lesions) per Lugano response criteria. CR rate is defined as the percentage of participants who experience a CR. The CR rate as assessed by physician investigator will be presented. - Part 2: Progression-Free Survival (PFS) — Up to approximately 63 months
PFS is defined as the time from randomization to the first documented disease progression per Lugano response criteria by Blinded Independent Central Review (BICR) or death due to any cause, whichever occurs first.
Trial sites (32)
| Facility | City | Region | Status |
|---|---|---|---|
| City of Hope - Duarte Cancer Center ( Site 1301) | Duarte | California | Recruiting |
| University of Kentucky ( Site 1303) | Lexington | Kentucky | Recruiting |
| John Theurer Cancer Center at Hackensack University Medical Center ( Site 1311) | Hackensack | New Jersey | Recruiting |
| Duke Cancer Center Clinic 1B/C Onc/Heme ( Site 1307) | Durham | North Carolina | Recruiting |
| SCRI Oncology Partners ( Site 7000) | Nashville | Tennessee | Recruiting |
| Instituto Alexander Fleming ( Site 0105) | Ciudad Autonoma de Buenos Aires | Buenos Aires | Recruiting |
| Hospital Aleman ( Site 0101) | Buenos Aires | Buenos Aires F.D. | Recruiting |
| Sanatorio Nuestra Senora del Rosario ( Site 0104) | Rosario | Santa Fe Province | Recruiting |
| Hospital Privado Universitario de Córdoba ( Site 0102) | Córdoba | Argentina | Recruiting |
| Box Hill Hospital ( Site 0201) | Box Hill | Victoria | Recruiting |
| Biocenter ( Site 0402) | Concepción | Biobio | Recruiting |
| Fundacion Arturo Lopez Perez FALP ( Site 0404) | Santiago | Region M. de Santiago | Recruiting |
| Beijing Cancer hospital ( Site 0501) | Beijing | Beijing Municipality | Recruiting |
| Fudan University Shanghai Cancer Center ( Site 0504) | Shanghai | Shanghai Municipality | Recruiting |
| Evangelismos General Hospital of Athens ( Site 1501) | Athens | Attica | Recruiting |
| General Hospital of Athens "Laiko" ( Site 1502) | Athens | Attica | Recruiting |
| Hadassah Medical Center ( Site 0701) | Jerusalem | Israel | Recruiting |
| Sheba Medical Center ( Site 0702) | Ramat Gan | Israel | Recruiting |
| Sourasky Medical Center ( Site 0704) | Tel Aviv | Israel | Recruiting |
| Pratia MCM Krakow ( Site 1702) | Krakow | Lesser Poland Voivodeship | Recruiting |
| Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 1701) | Warsaw | Masovian Voivodeship | Recruiting |
| Samsung Medical Center ( Site 0801) | Seoul | South Korea | Recruiting |
| Institut Català d'Oncologia (ICO) - Badalona ( Site 0904) | Badalona | Barcelona | Recruiting |
| Hospital Virgen de la Victoria ( Site 0905) | Málaga | Malaga | Recruiting |
| Hospital Universitari Vall de Hebron ( Site 0903) | Barcelona | Spain | Recruiting |
| Hospital Universitario Gregorio Maranon ( Site 0902) | Madrid | Spain | Recruiting |
| Hospital Universitario de Salamanca ( Site 0906) | Salamanca | Spain | Recruiting |
| National Taiwan University Hospital ( Site 1001) | Taipei | Taiwan | Recruiting |
| Chang Gung Medical Foundation-Linkou Branch ( Site 1002) | Taoyuan | Taiwan | Recruiting |
| Hacettepe Universite Hastaneleri ( Site 1110) | Ankara | Turkey (Türkiye) | Recruiting |
| Sisli Florence Nightingale Hastanesi ( Site 1112) | Istanbul | Turkey (Türkiye) | Recruiting |
| Ondokuz Mayıs Universitesi ( Site 1113) | Samsun | Turkey (Türkiye) | Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07634471 on ClinicalTrials.gov ↗ ← All trials in South Korea