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NCT Number: NCT05209620

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university

Zhengzhou, Henan, China

Location status: Recruiting

Location contact

Yanyan Liu, M.D. Ph.D

PRINCIPAL_INVESTIGATOR

Zhihua Yao, M.D. Ph.D

CONTACT

[email protected]

+8613592622292

Zhihua Yao, M.D. Ph.D

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

ICP-022

Drug

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 names: orelabrutinib

Pemetrexed

Drug

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

Other names: Pemetrexed injection

Primary outcomes

  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 outcomes

  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)

Study contacts

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

Yanyan Liu, M.D. Ph.D

CONTACT

[email protected]

+8613838176375

Zhihua Yao, M.D. Ph.D

CONTACT

[email protected]

+8613592622292

Sponsors and collaborators

Lead sponsor

Henan Cancer Hospital

Other Gov

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Jan 26, 2022
Registry last updated
Apr 23, 2025

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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