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Orelabrutinib Combined With Pemetrexed For Relapsed/Refractory Central Nervous System Lymphoma

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: NCT05209620
Recruitment Status : Recruiting
First Posted : January 26, 2022
Last Update Posted : February 11, 2022
Sponsor:
Information provided by (Responsible Party):
Zhihua Yao, PhD, Henan Cancer Hospital

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.

Condition or disease Intervention/treatment Phase
Central Nervous System Lymphoma Drug: ICP-022 Drug: Pemetrexed Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : December 21, 2021
Estimated Primary Completion Date : December 21, 2024
Estimated Study Completion Date : December 21, 2026


Arm Intervention/treatment
Experimental: Orelabrutinib Combined with Pemetrexed

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).

Drug: ICP-022

Induction Chemotherapy: Orelabrutinib, 150mg/d continuous oral administration (3 weeks/cycle, total 6 cycles).

Maintenance Treatment: Orelabrutinib, 150mg/d continuous oral administration (28d/cycle).

Other Name: orelabrutinib

Drug: Pemetrexed
Induction Chemotherapy: Pemetrexed, 500mg/m2, Intravenous administration on day 5 of each 3-week cycle (Total 6 cycles).
Other Name: Pemetrexed injection




Primary Outcome Measures :
  1. objective response rate [ 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) ]
    the total proportion of patients with complete response (CR) and partial response (PR)


Secondary Outcome Measures :
  1. progression-free survival [ 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) ]
    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

  2. overall survival [ 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) ]
    from date of first day of treatment to the date of death by any cause

  3. The incidence of grade 3-4 adverse events [ Time Frame: up to 5 years ]
    the incidence of grade 3 or 4 adverse events (based on NCI CTC-AE v5.0)



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age between 18 to 75 years old (including 18 and 75)
  2. 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
  3. Having at least one measurable lesions
  4. 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)
  5. Life expectancy no less than 1 month
  6. enough main organ function
  7. 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
  8. Agreeing to sign the written informed consents

Exclusion Criteria:

  1. Poor peripheral disease control of secondary central nervous system lymphoma
  2. Patients used pemetrexed or orelabrutinib in the past
  3. Active malignant tumor need be treated at the same time
  4. Other malignant tumor history
  5. Serious surgery and trauma less than two weeks
  6. Patients with active tuberculosis
  7. Systemic therapy for serious acute/chronic infection
  8. Congestive heart failure, uncontrolled coronary heart disease, arrhythmia and heart infarction less than 6 months
  9. HIV-positive, AIDS patients and untreated active hepatitis
  10. Patients with a history of deep vein thrombosis or pulmonary embolism less than 12 months
  11. Patients with a history of mental illness or drug abuse
  12. Poor compliance during the trial and/or follow-up phase
  13. Allergies or people who are known to be allergic to any active ingredients, excipients, mouse-derived products or heterologous protein contained in this trial
  14. Researchers determine unsuited to participate in this trial

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): NCT05209620


Contacts
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Contact: Zhihua Yao, M.D. Ph.D +8613592622292 zlyyyaozhihua1260@zzu.edu.cn
Contact: Yanyan Liu, M.D. Ph.D +8613838176375 yyliu@zzu.edu.cn

Locations
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China, Henan
Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university Recruiting
Zhengzhou, Henan, China
Contact: Zhihua Yao, M.D. Ph.D    +8613592622292    zlyyyaozhihua1260@zzu.edu.cn   
Principal Investigator: Zhihua Yao, M.D. Ph.D         
Principal Investigator: Yanyan Liu, M.D. Ph.D         
Sponsors and Collaborators
Henan Cancer Hospital
Investigators
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Study Director: Zhihua Yao, M.D. Ph.D Henan Cancer Hospital
Study Director: Yanyan Liu, M.D. Ph.D Henan Cancer Hospital
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Responsible Party: Zhihua Yao, PhD, Director, Henan Cancer Hospital
ClinicalTrials.gov Identifier: NCT05209620    
Other Study ID Numbers: HNSZLYYNHL06
First Posted: January 26, 2022    Key Record Dates
Last Update Posted: February 11, 2022
Last Verified: January 2022

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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 Zhihua Yao, PhD, Henan Cancer Hospital:
Central Nervous System Lymphoma
BTK inhibitor
Relapsed and Refractory
Additional relevant MeSH terms:
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Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Pemetrexed
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors