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NCT Number: NCT05846763

Obinutuzumab in Combination With Lenalidomide in Relapsed or Refractory Follicular Lymphoma in Real World Study

This study is planned to prospectively observe and verify the efficacy and safety of induction therapy with obinutuzumab in combination with lenalidomide followed by maintenance therapy with obinutuzumab and lenalidomide in patients with R/R FL in a real-world setting in a Chinese population.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Institute of Hematology and Blood Diseases Hospital ,Chinese Academy of Medical Sciences

Tianjin, 300020, China

Location status: Recruiting

Location contact

Rui Lyu

CONTACT

86-22-23909106

About this study

Available data have shown that the combination of obinutuzumab and lenalidomide has shown good efficacy and safety in patients with R/R FL, but the efficacy and safety in Chinese patients remain to be verified.

This study is planned to prospectively observe and verify the efficacy and safety of induction therapy with obinutuzumab in combination with lenalidomide followed by maintenance therapy with obinutuzumab and lenalidomide in patients with R/R FL in a real-world setting in a Chinese population.

The main questions it aims to answer are:

  • To assess the ORR in the R/R FL patient population treated with the combination of obinutuzumab and lenalidomide
  • To assess CRR, PFS, EFS, DOR, OS, and safety in patients with R/R FL treated with the combination of obinutuzumab and lenalidomide

Participants in this study will not and should not result in any intervention to the patient's treatment and visits. All treatments and visits for patients will be at the physician's discretion according to clinical practice

Who can participate

Healthy volunteers accepted: No

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

Patients must meet the following criteria for study entry::

  • Signed Informed Consent Form
  • Age ≥ 18 years at enrollment
  • At least one prior line of systemic (Stage III-IV) follicular lymphoma therapy
  • Relapsed or refractory to front-line anti-lymphoma therapy; refractory is defined as: tumor shrinkage of less than 50% or disease progression after 4 cycles of standard regimen chemotherapy; response to standard regimen chemotherapy, relapse within 24 months; 2 or more relapses, meeting one of the above criteria as refractory lymphoma.
  • Conditional treatment with obinutuzumab in combination with lenalidomide

Exclusion criteria

  • Patients currently participating or planning to participate in any interventional clinical trial
  • Any other reason that, in the opinion of the investigator, makes the patient unsuitable for this study

Treatment and study plan

Primary outcomes

  1. overall response rate(ORR)

    Time frame: 24 weeks

    Proportion of patients with complete response (CR) and partial response (PR) after the end of induction therapy.

Secondary outcomes

  1. 2-year Progression free survival(PFS24)

    Time frame: Up to 4.5 years

    Time to first disease progression or death from any cause within two years from enrollment.

  2. 2-year Event-free survival(EFS24)

    Time frame: Up to 4.5 years

    Time to any event, including disease progression, discontinuation of treatment for any reason, or death within two years from enrollment.

  3. Complete response (CR)

    Time frame: 2.5 years

    Proportion of patients with complete response at the end of treatment

  4. Duration of response (DoR)

    Time frame: Up to 4.5 years

    Time from enrollment to disease progression or death for patients with a complete or partial response

  5. Overall survival (OS)

    Time frame: Up to 4.5 years

    Time to death from any cause from the date of enrollment

  6. Safety(Proportion of Grade 3-4 Hematologic and Non-Hematologic Toxicities)

    Time frame: 4.5 years

    All hematological and non-hematological toxicities from enrollment to 28 days after the end of treatment

Study contacts

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

Lugui Qiu, Dr

CONTACT

[email protected]

86-22-23909172

shuhua Yi, Dr

CONTACT

[email protected]

86-22-23909106

Sponsors and collaborators

Lead sponsor

Institute of Hematology & Blood Diseases Hospital, China

Other

Registry information

Official study title

Efficacy and Safety of Obinutuzumab in Combination With Lenalidomide in Patients With Relapsed and Refractory Follicular Lymphoma (R/R FL): A Prospective Observational Study

Important dates

Study start
2022
Primary completion
2026
Study completion
2028
First posted
May 6, 2023
Registry last updated
May 23, 2023

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.

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