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Lenalidomide Combined With Rituximab as Front-line Therapy for DLBCL Patients Aged Over 80 Years (R2DLBCL80)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04622579
Recruitment Status : Recruiting
First Posted : November 10, 2020
Last Update Posted : November 10, 2020
Sponsor:
Collaborators:
Guangzhou First People's Hospital
Foshan First People's Hospital
Huizhou Municipal Central Hospital
Shantou Central Hospital
Information provided by (Responsible Party):
Wenyu Li, Guangdong Provincial People's Hospital

Study Description
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Brief Summary:
About 40% of Diffuse large B cell lymphoma relapse or is refractory, age is a prognostic factor of DLBCL, as elderly patients are not capable to received standard treatment, the prognosis of elderly patients is poor especially those aged over 80 years. In this study,we aimed to investigate the safety and efficacy of the combination of lenalidomide and rituximab in elderly patients aged ≥ 80 years with untreated DLBCL.

Condition or disease Intervention/treatment Phase
Diffuse Large B Cell Lymphoma Age Over 80 Years Drug: lenalidomide combined with rituximab Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Lenalidomide Combined With Rituximab as Front-line Therapy in Elderly Patients Aged Over 80 Years With Diffuse Large B Cell Lymphoma
Actual Study Start Date : October 23, 2020
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : March 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arms and Interventions
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Arm Intervention/treatment
Experimental: lenalidomide combined with rituximab
Rituximab 375 mg/m2 i.v d1 q28d； Lenalidomide 10mg Po. d1-21 q28d. After 6 cycles, patients obtained CR or PR will continue with Lenalidomide maintenance till the 24th month.
 Drug: lenalidomide combined with rituximab
lenalidomide and rituximab are dilivered as described, parameters concerning efficacy and safety are also obtained.


Outcome Measures
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Primary Outcome Measures :
  1. ORR [ Time Frame: 24 months ]
    Overall response rate


Secondary Outcome Measures :
  1. CR [ Time Frame: 24 months ]
    Complete response

  2. OS [ Time Frame: from date of treatment until the date of death from any cause, assessed up to 5 years ]
    Overall survival

  3. PFS [ Time Frame: from date of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years ]
    Progression-free survival


Eligibility Criteria
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Ages Eligible for Study:   80 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age≧80 years ;
  2. ECOG score 0-2；
  3. untreated with pathologically confirmed CD20+ DLBCL ;
  4. expected life expectancy of ≥ 12 weeks;
  5. capable of swallowing tablets;
  6. GFR(by Cockcroft- Gault)≥30 ml/min;
  7. can sign written informed consent to participate in the study.

Exclusion Criteria:

  1. with CNS involvement;
  2. with other malignancy (not including adequate-treated non-melanoma cutaneum carcinoma); patients with other cancer but disease-free for ≥5 years can enter this study;
  3. with ≥ grade 2 peripheral neurophathy;
  4. with cardiopathy including unstable angia or myocardial infarction over the past 8 weeks;
  5. received live vaccine within 28 days.;
  6. HIV-positive;
  7. thrombosis ;
  8. GFR<30 mL/min;
  9. other conditions not suitable for rituximab or lenalidomide application.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04622579


Contacts
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Contact: Xinmiao Jiang （+86）20-83827812 296260860@qq.com

Locations
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China, Guangdong
Guangdong provincial people's hospital Recruiting
Guangzhou, Guangdong, China, 510080
Contact: Xinmiao Jiang    +86 20 81884713-80631    296260860@qq.com   
Sponsors and Collaborators
Guangdong Provincial People's Hospital
Guangzhou First People's Hospital
Foshan First People's Hospital
Huizhou Municipal Central Hospital
Shantou Central Hospital
More Information
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Responsible Party: Wenyu Li, professor of medicine, Guangdong Provincial People's Hospital
ClinicalTrials.gov Identifier: NCT04622579    
Other Study ID Numbers: 2020099H
First Posted: November 10, 2020    Key Record Dates
Last Update Posted: November 10, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wenyu Li, Guangdong Provincial People's Hospital:
lenalidomide
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Rituximab
 Lenalidomide
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors