Back to resultsOrelabrutinib Combined With Pemetrexed For Relapsed/Refractory Central Nervous System Lymphoma
Primary Purpose
Central Nervous System Lymphoma
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
ICP-022
Pemetrexed
Sponsored by
About this trial
This is an interventional treatment trial for Central Nervous System Lymphoma focused on measuring Central Nervous System Lymphoma, BTK inhibitor, Relapsed and Refractory
Eligibility Criteria
Inclusion Criteria:
- Age between 18 to 75 years old (including 18 and 75)
- Diagnosed as diffuse large B-cell lymphoma; Recurrence or progression of central nervous system disease confirmed by imaging ± tissue biopsy pathology or cerebrospinal fluid flow cytometry; Secondary central nervous system lymphoma can also be admitted when the systemic disease is well controlled
- Having at least one measurable lesions
- World health organization-Eastern Cooperative Oncology Group Performance Status (ECOG) 0-2 ( ECOG 3 due to tumors can be included after being fully assessed by the investigator)
- Life expectancy no less than 1 month
- enough main organ function
- Pregnancy test within 7 days must be negative for women of childbearing period, and appropriate measures should be taken for contraception for women in childbearing period during the study and six months after this study
- Agreeing to sign the written informed consents
Exclusion Criteria:
- Poor peripheral disease control of secondary central nervous system lymphoma
- Patients used pemetrexed or orelabrutinib in the past
- Active malignant tumor need be treated at the same time
- Other malignant tumor history
- Serious surgery and trauma less than two weeks
- Patients with active tuberculosis
- Systemic therapy for serious acute/chronic infection
- Congestive heart failure, uncontrolled coronary heart disease, arrhythmia and heart infarction less than 6 months
- HIV-positive, AIDS patients and untreated active hepatitis
- Patients with a history of deep vein thrombosis or pulmonary embolism less than 12 months
- Patients with a history of mental illness or drug abuse
- Poor compliance during the trial and/or follow-up phase
- Allergies or people who are known to be allergic to any active ingredients, excipients, mouse-derived products or heterologous protein contained in this trial
- Researchers determine unsuited to participate in this trial
Sites / Locations
- Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou universityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Orelabrutinib Combined with Pemetrexed
Arm Description
Induction Chemotherapy: Orelabrutinib, 150mg/d continuous oral administration, Pemetrexed, 500mg/m2, Intravenous administration on day 5 of each 3-week cycle (Total 6 cycles). Maintenance Treatment: Orelabrutinib, 150mg/d continuous oral administration (28d/cycle).
Outcomes
Primary Outcome Measures
objective response rate
the total proportion of patients with complete response (CR) and partial response (PR)
Secondary Outcome Measures
progression-free survival
the total proportion of patients with no progression from date of the first day of treatment to the date of confirmed progressive disease or death which one occurs first
overall survival
from date of first day of treatment to the date of death by any cause
The incidence of grade 3-4 adverse events
the incidence of grade 3 or 4 adverse events (based on NCI CTC-AE v5.0)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05209620
Brief Title
Orelabrutinib Combined With Pemetrexed For Relapsed/Refractory Central Nervous System Lymphoma
Official Title
A Single Arm, Phase II Clinical Trial of Orelabrutinib Combined With Pemetrexed in the Treatment for Patients With Relapsed/Refractory Central Nervous System Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 21, 2021 (Actual)
Primary Completion Date
December 21, 2024 (Anticipated)
Study Completion Date
December 21, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Henan Cancer Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a prospective single arm, phase II clinical trial to observe the efficacy and safety of orelabrutinib combined with pemetrexed in the treatment for patients with relapsed/refractory central nervous system lymphoma.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Central Nervous System Lymphoma
Keywords
Central Nervous System Lymphoma, BTK inhibitor, Relapsed and Refractory
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Orelabrutinib Combined with Pemetrexed
Arm Type
Experimental
Arm Description
Induction Chemotherapy: Orelabrutinib, 150mg/d continuous oral administration, Pemetrexed, 500mg/m2, Intravenous administration on day 5 of each 3-week cycle (Total 6 cycles).
Maintenance Treatment: Orelabrutinib, 150mg/d continuous oral administration (28d/cycle).
Intervention Type
Drug
Intervention Name(s)
ICP-022
Other Intervention Name(s)
orelabrutinib
Intervention Description
Induction Chemotherapy: Orelabrutinib, 150mg/d continuous oral administration (3 weeks/cycle, total 6 cycles).
Maintenance Treatment: Orelabrutinib, 150mg/d continuous oral administration (28d/cycle).
Intervention Type
Drug
Intervention Name(s)
Pemetrexed
Other Intervention Name(s)
Pemetrexed injection
Intervention Description
Induction Chemotherapy: Pemetrexed, 500mg/m2, Intravenous administration on day 5 of each 3-week cycle (Total 6 cycles).
Primary Outcome Measure Information:
Title
objective response rate
Description
the total proportion of patients with complete response (CR) and partial response (PR)
Time Frame
every 6 weeks from the day of the first cycle of induction chemotherapy treatment (each cycle is 21 days) and every 8 weeks from the day of the first cycle of maintenance treatment to 5 years after last patient's enrollment (each cycle is 28 days)
Secondary Outcome Measure Information:
Title
progression-free survival
Description
the total proportion of patients with no progression from date of the first day of treatment to the date of confirmed progressive disease or death which one occurs first
Time Frame
every 6 weeks from the day of the first cycle of induction chemotherapy treatment (each cycle is 21 days) and every 8 weeks from the day of the first cycle of maintenance treatment to 5 years after last patient's enrollment (each cycle is 28 days)
Title
overall survival
Description
from date of first day of treatment to the date of death by any cause
Time Frame
every 6 weeks from the day of the first cycle of induction chemotherapy treatment (each cycle is 21 days) and every 8 weeks from the day of the first cycle of maintenance treatment to 5 years after last patient's enrollment (each cycle is 28 days)
Title
The incidence of grade 3-4 adverse events
Description
the incidence of grade 3 or 4 adverse events (based on NCI CTC-AE v5.0)
Time Frame
up to 5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age between 18 to 75 years old (including 18 and 75)
Diagnosed as diffuse large B-cell lymphoma; Recurrence or progression of central nervous system disease confirmed by imaging ± tissue biopsy pathology or cerebrospinal fluid flow cytometry; Secondary central nervous system lymphoma can also be admitted when the systemic disease is well controlled
Having at least one measurable lesions
World health organization-Eastern Cooperative Oncology Group Performance Status (ECOG) 0-2 ( ECOG 3 due to tumors can be included after being fully assessed by the investigator)
Life expectancy no less than 1 month
enough main organ function
Pregnancy test within 7 days must be negative for women of childbearing period, and appropriate measures should be taken for contraception for women in childbearing period during the study and six months after this study
Agreeing to sign the written informed consents
Exclusion Criteria:
Poor peripheral disease control of secondary central nervous system lymphoma
Patients used pemetrexed or orelabrutinib in the past
Active malignant tumor need be treated at the same time
Other malignant tumor history
Serious surgery and trauma less than two weeks
Patients with active tuberculosis
Systemic therapy for serious acute/chronic infection
Congestive heart failure, uncontrolled coronary heart disease, arrhythmia and heart infarction less than 6 months
HIV-positive, AIDS patients and untreated active hepatitis
Patients with a history of deep vein thrombosis or pulmonary embolism less than 12 months
Patients with a history of mental illness or drug abuse
Poor compliance during the trial and/or follow-up phase
Allergies or people who are known to be allergic to any active ingredients, excipients, mouse-derived products or heterologous protein contained in this trial
Researchers determine unsuited to participate in this trial
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhihua Yao, M.D. Ph.D
Phone
+8613592622292
Email
zlyyyaozhihua1260@zzu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Yanyan Liu, M.D. Ph.D
Phone
+8613838176375
Email
yyliu@zzu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhihua Yao, M.D. Ph.D
Organizational Affiliation
Henan Cancer Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Yanyan Liu, M.D. Ph.D
Organizational Affiliation
Henan Cancer Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university
City
Zhengzhou
State/Province
Henan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhihua Yao, M.D. Ph.D
Phone
+8613592622292
Email
zlyyyaozhihua1260@zzu.edu.cn
First Name & Middle Initial & Last Name & Degree
Zhihua Yao, M.D. Ph.D
First Name & Middle Initial & Last Name & Degree
Yanyan Liu, M.D. Ph.D
12. IPD Sharing Statement
Learn more about this trial
Orelabrutinib Combined With Pemetrexed For Relapsed/Refractory Central Nervous System Lymphoma
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