Mosunetuzumab by subcutaneous injection as first-line therapy for low tumor burden follicular lymphoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multi-center, open-label Phase 2 study evaluating the efficacy and safety of subcutaneous mosunetuzumab as a first-line immunotherapy in patients with low tumor burden follicular lymphoma (LTB-FL). Eligible participants will receive mosunetuzumab by subcutaneous injection on a defined schedule over up to 8 cycles (~6 months), with premedication in Cycle 1 and ongoing monitoring of disease status. The trial includes a post-treatment follow-up with periodic imaging and disease status assessments for up to 24 months. Data collected cover demographics, disease characteristics, and treatment-related safety and activity outcomes. The study is sponsored by Tel-Aviv Sourasky Medical Center with collaboration from Hoffmann-La Roche and participating centers in Israel.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* at least 18 years old
* Histologically confirmed classic FL (cFL) (according to WHO-HEAM4R classification)
* Low tumor burden by GELF criteria
* No prior therapy except surgery or radiotherapy for disease that was previously localized
* Ann Arbor Stage III or IV disease
* Bi-dimensionally measurable FDG-avid disease defined by at least one single node or tumor lesion \> 1.5 cm assessed by CT scan and/or clinical examination
* Adequate hematologic function defined as follows without growth factors or blood product transfusion within 14 days of first dose of study drug administration:

  1. Hemoglobin, without transfusion, 9 g/dL
  2. ANC 1.0 109/L
  3. Platelet count 75 109/L;
* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
* Patient can understand and sign the Informed Consent Form (ICF), can communicate with the Investigator, can understand and comply with the requirements of the protocol

Exclusion Criteria:

* 1\. An active viral infection with hepatitis B virus (HBV) or hepatitis C virus (HCV) defined by detectable viral DNA in the blood by PCR. Patients with HIV are eligible provided an undetectable viral load and a CD4 count \> 200 cell/mcl
* 2\. Any of the following laboratory abnormalities:

  1. Total Bilirubin or GGT or AST or ALT \> 3 X ULN.
  2. Creatinine Clearance calculated by Cockcroft and Gault Formula \< 40 ml/min
* Presence or history of CNS involvement by lymphoma
* 4\. Prior history of malignancies other than Lymphoma (except for Basal Cell or Squamous Cell Carcinoma of the skin or carcinoma in situ of the cervix or breast) unless the subject has been free of the disease for ≥ 2 years
* Contraindication to use Mosunetuzumabor known sensitivity or allergy
* Pregnant or lactating females
* 7\. Female patients of childbearing potential who cannot or do not wish to use an effective method of contraception, during the study treatment and for 3 months thereafter

Where it's running

• Rambam Health Care Campus
  Haifa, Israel Recruiting
• Shaare Zedek Medical Center
  Jerusalem, Israel Recruiting
• The Hadassah University Hospital-Ein Kerem
  Jerusalem, Israel Recruiting
• Tel Aviv Sourasky Medical Center (TASMC) - Ichilov
  Tel Aviv, Israel Recruiting

Study contacts

• Principal investigator: Irit Avivi, Prof — Tel-Aviv Sourasky Medical Center
• Study coordinator: Irit Avivi, Prof
• Email: iritavi@tlvmc.gov.il
• Phone: +972 3-6974452

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.