Ibrutinib Combined With R-CHOP/R-DHAP in Newly Diagnosed Mantle Cell Lymphoma Patients Who Aged ≤65 Years

NCT05429918 | Unknown

• 1 other identifier: M2021028
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to better and systematically collect clinical data on the treatment of ibrutinib combined with R-CHOP/DHAP regimen for more scientific and accurate evaluation, our center has carried out the R-CHOP/R-DHAP alternative regimen combined with ibrutinib at age ≤ An observational clinical study on the safety and effectiveness of 65-year-old mantle cell lymphoma. Through this study, young mantle cell lymphomas in the Chinese population can be collected. Ibrutinib combined with R-CHOP/R-DHAP is used in the initial treatment. 2 and 6 cycles of ORR were used to evaluate survival indicators, and collect adverse reactions during treatment and recurrence rate after treatment.

Conditions

Mantle Cell Lymphoma

Keywords

MCL; ibrutinib; aged ≤65 years

Outcome Measures

Primary Outcomes (2)

• the overall response (complete response + partial response)

  Objective response rate，sum of complete response rate and partial response rate of ibrutinib combination therapy in initial treatment of MCL

  From the date of first study drug administration until the end of Cycle 2 (each cycle is 28 days)

• the overall response (complete response + partial response)

  Objective response rate，sum of complete response rate and partial response rate of ibrutinib combination therapy in initial treatment of MCL

  From the date of first study drug administration until the end of Cycle 6 (each cycle is 28 days)

Secondary Outcomes (4)

• Progression-free survival (PFS),OS,CR,DOR

  2years

• Incidence and severity of adverse events(AE)

  2 years

• The recurrence rate of MCL after initial treatment with ibrutinib

  2years

• Minimal residual disease negative (MRD-) rate of patients combination therapy

  1year and 2years

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

60 patients with primary mantle cell lymphoma

You may qualify if:

• age 18-65 years old;
• The pathological biopsy was consistent with mantle cell lymphoma;
• Measurable lesions on cross-sectional imaging recorded by diagnostic imaging (computed tomography \[CT\] or magnetic resonance imaging \[MRI\]) (defined as the presence of at least one two-dimensional measurable lesion with a maximum cross-sectional diameter (GTD) ≥1.5 cm, regardless of the short axis diameter);
• The physical status of the Eastern United States Cooperative Oncology Group (ECOG) ≤2 points;
• Full liver function: upper limit of bilirubin≤3×normal value (ULN);Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤5×ULN; Alkaline phosphatase (ALP) ≤5×ULN; Serum creatinine ≤1.5×ULN, or creatinine clearance rate calculated according to Cockcroft-Gault formula ≥35mL/min;
• Voluntary participation, willingness to provide the above treatment data, signed and dated informed consent -

You may not qualify if:

• Other clinical trials have been included;
• Immunosuppressive therapy is being used for other diseases;
• Lymphoma has been treated with other regimens before entry;
• Complicated with other malignant tumors;
• Those who are judged by the investigator to be unsuitable to participate in this study;
• Serious mental or neurological disorder that affects informed consent and/or the presentation or observation of adverse reactions;
• Patients who could not be followed up
• Exit (drop-off) criteria :
• Subject requires to quit;
• Serious adverse events occurred during the trial, so it is inappropriate to continue the clinical trial;
• If the disease progresses during the study, it is inappropriate to continue using the experimental drug and/or cannot continue the study protocol;
• Incomplete research data records;
• Patients could not be followed up.Withdrawal cases should be retained for future reference and transferred from the last record to the final record for ITT analysis.

Sponsors & Collaborators

• Peking University Third Hospital: lead
• The Second Affiliated Hospital of Dalian Medical University: collaborator
• Peking University First Hospital: collaborator
• Beijing Hospital: collaborator
• Beijing Tsinghua Changgeng Hospital: collaborator
• China-Japan Friendship Hospital: collaborator
• Chinese PLA General Hospital: collaborator
• First Affiliated Hospital of Harbin Medical University: collaborator
• Baotou Cancer Hospital: collaborator
• Beijing Shijitan Hospital, Capital Medical University: collaborator
• Shanxi Province Cancer Hospital: collaborator
• Beijing Naval General Hospital: collaborator
• First Hospital of China Medical University: collaborator
• Jilin Provincial Tumor Hospital: collaborator
• Shengjing Hospital: collaborator
• 307 Hospital of PLA: collaborator
• Peking Union Medical College Hospital: collaborator
• Harbin Medical University: collaborator
• Beijing Tongren Hospital: collaborator

Study Sites (1)

Hongmei Third Jing

Beijing, Beijing Municipality, 100083, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Mantle-Cell

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Hongmei Jing, Professor

  Peking University Third Hospital

  STUDY CHAIR

Central Study Contacts

Hongmei T Jing, Professor

CONTACT

+861082265571; hongmeijing@bjmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2021
• First Posted: June 23, 2022
• Study Start: December 30, 2020
• Primary Completion: December 30, 2023
• Study Completion: June 30, 2024
• Last Updated: June 23, 2022

Record last verified: 2022-06

Locations

CN (1)