Clinical trial NCT06425302: A Study to Evaluate the Efficacy and Safety of Golcadomide in Combination With Rituximab in Participants With Newly Diagnosed Advanced Stage Follicular Lymphoma
Official title: A Phase 2 Randomized, Open Label Study to Evaluate the Efficacy and Safety of Golcadomide in Combination With Rituximab in Participants With Newly Diagnosed Advanced Stage Follicular Lymphoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Lymphoma, Follicular
Keywords: Follicular lymphoma
Grade 1-3a Follicular lymphoma
BMS-986369
CC-99282
Lymphoma
golcadomide
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2024-05-22
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the efficacy and safety of golcadomide in combination with rituximab in participants with newly diagnosed advanced stage Follicular Lymphoma (FL).


Eligibility criteria: Inclusion Criteria

* Participant has histologically confirmed Grade 1, 2 or 3a follicular lymphoma (FL) or classic FL. Formalin-fixed paraffin embedded (FFPE) archival tissue from 1 year prior to screening is allowed. If more than 1 year has passed, then a fresh biopsy must be obtained to confirm the diagnosis.
* Have no prior systemic treatment for follicular lymphoma. Prior radiation therapy or surgery for previously diagnosed stage I disease is acceptable.
* Stage II to IV disease.
* Deemed to need treatment by treating investigator. Reasons for treatment can include, but are not limited to, the following:.

  i) Bulky disease defined as:.

A. A nodal or extra nodal (except spleen) mass \> 7cm in its greater diameter or, involvement of at least 3 nodal or extra nodal sites (each with a diameter greater than \>3 cm).

ii) Presence of at least one of the following B symptoms:.

A. Fever (\>38°C) of unclear etiology.

B. Night sweats.

C. Weight loss greater than 10% within the prior 6 months.

iii) Splenomegaly with inferior margin below the umbilical line.

iv) Any one of the following cytopenia due to lymphoma:.

A. Platelets \<100,000 cells/mm3 (100 x 109/L).

B. Absolute neutrophil count (ANC) \< 1,000 cells/mm3 (1.0 x 109/L).

C. Hemoglobin \< 10g/dL (6.25 mmol/L).

v) Pleural or peritoneal serous effusion (irrespective of cell content).

vi) Any compressive syndrome (for example, but not restricted to ureteral, orbital, gastrointestinal).

Exclusion Criteria

* Clinical evidence of transformed lymphoma by investigator assessment.
* Follicular Large Cell as per WHO 5th classification or Grade 3b follicular lymphoma as per WHO 4th classification.
* Participant has any significant medical condition, active infection, laboratory abnormality, or psychiatric illness that would prevent the participation in the study.
* Other protocol-defined Inclusion/Exclusion criteria apply.

Primary outcomes:
measure: Number of participants who achieve complete metabolic response (CMR) as assessed by Lugano criteria 2014
timeFrame: Up to approximately 12 months from participant randomization
Secondary outcomes:
measure: Number of participants with Adverse Events (AEs) as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) criteria, v.5.0
timeFrame: Up to 28 days after last dose
measure: Number of participants with Treatment-emergent AEs (TEAEs) as assessed by the NCI CTCAE criteria, v.5.0
timeFrame: Up to 28 days after last dose
measure: Best Overall Response (OR)
timeFrame: Up to approximately 12 months from participant randomization
measure: Duration of Response (DoR)
timeFrame: Up to approximately 3 years after randomization of the last participant
measure: Complete Response at 30 months (CR30)
timeFrame: At approximately 30 months from randomization
measure: Complete Metabolic Response at 6 months from the randomization (CMR6)
timeFrame: At approximately 6 months from randomization
measure: Complete Metabolic Response at 12 months from the randomization (CMR12)
timeFrame: At approximately 12 months from randomization
measure: Progression Free Survival (PFS)
timeFrame: Up to approximately 3 years from randomization of last participant
measure: Overall Survival (OS)
timeFrame: Up to approximately 3 years from randomization of last participant
measure: Number of participants who achieve CMR as assessed by Lugano criteria 2014
timeFrame: Up to approximately 6 months from randomization
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Local Institution - 0152
state: Alabama
city: Anchorage
country: United States
facility: Alaska Oncology and Hematology
state: Alaska
city: Phoenix
country: United States
facility: Mayo Clinic in Arizona - Phoenix
state: Arizona
city: Tucson
country: United States
facility: Arizona Oncology Associates, PC - HOPE
state: Arizona
city: San Francisco
country: United States
facility: UCSF Helen Diller Medical Center at Parnassus Heights
state: California
city: Washington
country: United States
facility: Georgetown University Medical Center
state: District of Columbia
city: Fort Myers
country: United States
facility: Florida Cancer Specialists - South
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
city: Saint Petersburg
country: United States
facility: Florida Cancer Specialists - North
state: Florida
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: West Palm Beach
country: United States
facility: Florida Cancer Specialists - East
state: Florida
city: Westwood
country: United States
facility: The University of Kansas Cancer Center - Westwood
state: Kansas
city: Jefferson
country: United States
facility: Local Institution - 0173
state: Louisiana
city: Baltimore
country: United States
facility: Local Institution - 0033
state: Maryland
city: Boston
country: United States
facility: Local Institution - 0001
state: Massachusetts
city: Boston
country: United States
facility: Local Institution - 0004
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic in Rochester, Minnesota
state: Minnesota
city: Henderson
country: United States
facility: Comprehensive Cancer Centers Of Nevada
state: Nevada
city: Hackensack
country: United States
facility: John Theurer Cancer Center at Hackensack University Medical Center
state: New Jersey
city: New Brunswick
country: United States
facility: Local Institution - 0020
state: New Jersey
city: New York
country: United States
facility: Local Institution - 0036
state: New York
city: Salt Lake City
country: United States
facility: Utah Cancer Specialists
state: Utah
city: Norfolk
country: United States
facility: Local Institution - 0200
state: Virginia
city: Norfolk
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Seattle
country: United States
facility: Local Institution - 0166
state: Washington
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Center
state: Washington
city: Liverpool
country: Australia
facility: Liverpool Hospital
state: New South Wales
city: South Brisbane
country: Australia
facility: Mater Misercordiae Hospital
state: Queensland
city: Traralgon
country: Australia
facility: Latrobe Regional Health
state: Victoria
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre
state: Rio Grande Do Sul
city: Rio de Janeiro
country: Brazil
facility: Centro de Tratamento de Tumores Botafogo para Oncoclinicas Rio de Janeiro SA
city: Sao Paulo
country: Brazil
facility: Instituto D'Or de Pesquisa e Ensino (IDOR)
city: São Paulo
country: Brazil
facility: Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
city: Chicoutimi
country: Canada
facility: CIUSSS- saguenay-Lac-Saint-Jean
state: Quebec
city: Santiago
country: Chile
facility: Fundacion Arturo Lopez Perez (FALP)
state: Región Metropolitana De Santiago
city: Santiago
country: Chile
facility: Clínica Inmunocel
state: Región Metropolitana De Santiago
city: Saint-Cloud
country: France
facility: Institut Curie - site Saint-Cloud
state: Hauts-de-Seine
city: Lille
country: France
facility: Hopital Claude Huriez - CHU de Lille
state: Nord
city: Poitiers
country: France
facility: Centre Hospitalier Universitaire de Poitiers
state: Vienne
city: Paris
country: France
facility: Hôpital Saint-Louis
city: Regensburg
country: Germany
facility: Krankenhaus Barmherzige Brüder Regensburg
state: Bayern
city: Chemnitz
country: Germany
facility: Klinikum Chemnitz - Flemmingstraße
state: Sachsen
city: Dresden
country: Germany
facility: Gemeinschaftspraxis Hämatologie - Onkologie Freiberg-Richter, Jacobasch, Illmer, Wolf
city: Rome
country: Italy
facility: Fondazione Policlinico Tor Vergata
state: Lazio
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
state: Milano
city: Bari
country: Italy
facility: Local Institution - 0096
state: Puglia
city: Bari
country: Italy
facility: Local Institution - 0098
state: Puglia
city: Bari
country: Italy
facility: Local Institution - 0097
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori IRCCS Fondazione Pascale
city: Hwasun Gun
country: Korea, Republic of
facility: Local Institution - 0104
state: Jeonranamdo
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
state: Pusan-Kwangyǒkshi
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Seoul-teukbyeolsi [Seoul]
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
state: Seoul-teukbyeolsi [Seoul]
city: Bydgoszcz
country: Poland
facility: Local Institution - 0186
state: Kujawsko-pomorskie
city: Warszawa
country: Poland
facility: Luxmed Onkologia sp. z o. o.
state: Mazowieckie
city: Skórzewo
country: Poland
facility: Aidport
state: Wielkopolskie
city: Palma
country: Spain
facility: Hospital Universitari Son Espases
state: Balears [Baleares]
city: Valencia
country: Spain
facility: Hospital Universitario Doctor Peset
state: Valenciana, Comunitat
city: Madrid
country: Spain
facility: Hospital Universitario Fundación Jiménez Díaz
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
city: Kaohsiung
country: Taiwan
facility: Chang Gung Memorial Hospital at Kaohsiung
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Southampton
country: United Kingdom
facility: Southampton General Hospital
state: Hampshire
city: Canterbury
country: United Kingdom
facility: Kent and Canterbury Hospital
state: Kent
city: Edinburgh
country: United Kingdom
facility: Western General Hospital
state: Midlothian
city: Nottingham
country: United Kingdom
facility: City Hospital, Nottingham University Hospitals NHS Trust
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: