Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06961500

Obinutuzumab With CHOP Versus Obinutuzumab With Bendamustine in the Treatment of Newly Diagnosed Follicular Lymphoma Grade 3A

This is a multicenter, phase 2, randomized trial to evaluate the efficacy and safety of obinutuzumab with CHOP versus obinutuzumab with bendamustine in treatment-naïve follicular lymphoma (Grade 3A) patients.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sun Yat-sen Universitiy Cancer Center, Sun Yat-Sen University

Guangzhou, Guangdong, China

Location contact

Qingqing Cai

CONTACT

[email protected]

02087342823

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologically confirmed follicular lymphoma Grades 3A, CD20 positive by immunohistochemistry.
  • Meets at least one GELF (Groupe d'Etude des Lymphomes Folliculaires) criteria.
  • No prior systemic treatment for lymphoma.
  • Presence of measurable lesions.
  • Age ≥ 18 years, no gender restriction.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
  • Expected survival of > 3 months.
  • Adequate organ and bone marrow function.

Exclusion criteria

  • History of allergy to any component of monoclonal antibodies or investigational drugs.
  • Central nervous system involvement.
  • History of previous malignant tumors.
  • History of active bleeding or bleeding tendencies, or requiring anticoagulant medication.
  • Requirement for potent CYP3A4 inhibitors for treatment.
  • Active infection, except for tumor-related B symptoms.
  • Known history of Human Immunodeficiency Virus (HIV) infection and/or acquired immunodeficiency syndrome (AIDS).
  • Hepatitis C virus (HCV) antibody positive with HCV RNA quantitative test result exceeding the detection limit; Hepatitis B surface antigen (HBsAg) positive or Hepatitis B core antibody (HBcAb) positive, with Hepatitis B virus DNA quantitative test result exceeding the detection limit (for patients with HBsAg or HBcAb positive status, regardless of HBV-DNA detection, oral entecavir or other antiviral therapy must be initiated prior to enrollment and continued according to the physician's instructions during the trial).
  • Significant organ dysfunction or uncontrolled comorbidities, such as uncontrolled hypertension, decompensated cirrhosis, uncontrolled diabetes, chronic obstructive pulmonary disease, etc.
  • History of severe heart disease.
  • Major surgery within 4 weeks prior to enrollment.
  • Participation in other clinical trials with drug intervention within 4 weeks prior to enrollment.
  • Pregnant or breastfeeding women, or planning to become pregnant during the study.
  • Individuals with psychiatric disorders, history of alcohol or drug abuse, or inability to provide informed consent.
  • Investigator determines the patient is unsuitable for enrollment or may not be able to complete the trial for other reasons.

Treatment and study plan

Obinutuzumab

Drug

1000mg i.v., administered on Day 1/8/15 (D1/8/15) of Cycle 1 (C1), and D1 of C2-6

CHOP

Drug

a) Cyclophosphamide: 750 mg/m2 i.v. drip, administered on D1; b) Doxorubicin: 50 mg/m2 i.v. drip (or Epirubicin: 70mg/m2 i.v. drip), administered on D1; c) Vincristine: 1.4 mg/m2 i.v., administered on D1; d) Prednisone: 100mg/d po, administered on D1-5.

Bendamustine

Drug

90 mg/m2 i.v. drip, administered on D1-2.

Primary outcomes

  1. Progression-Free Survival (PFS)

    Time frame: Assessed up to 5 years.

    From study entry to the first documented disease progression or death from any cause.

Secondary outcomes

  1. Complete Response (CR)

    Time frame: Up to 6 cycles (up to 24 weeks).

    Defined as the proportion of patients who achieve complete remission at the end of induction therapy.

  2. Objective Response Rate (ORR)

    Time frame: Up to 6 cycles (up to 24 weeks).

    The proportion of patients who achieve complete remission (CR) or partial remission (PR) at the end of induction therapy.

  3. Event-Free Survival (EFS)

    Time frame: Assessed up to 5 years.

    From study entry to the first occurrence of any event, including disease progression, discontinuation of treatment, or death for any reason.

  4. Overall Survival (OS)

    Time frame: Assessed up to 5 years.

    From study entry to death from any cause.

  5. Progression of Disease within 24 months (POD24)

    Time frame: 24 months.

    The occurrence of disease progression or relapse within 24 months from the date of enrollment.

Study contacts

Contact information is provided by the study sponsor or research team.

Qingqing Cai

CONTACT

[email protected]

0086-020-87342823

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

A Multicenter, Phase 2, Randomized Trial of Obinutuzumab With CHOP Versus Obinutuzumab With Bendamustine in the Treatment of Newly Diagnosed Follicular Lymphoma Grade 3A (FL)

Acronym: PROOF

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
May 8, 2025
Registry last updated
May 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.