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PCNSLPhase 1/2NCT06554561

A Study of Pomadomide in Combination With Rituximab and Methotrexate for Newly-diagnosed Primary Central Nervous System Lymphoma

A Phase 1/2 study testing Pomalidomide, Rituximab and Methotrexate in people with PCNSL, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This is a prospective, multicenter, single-arm, open Phase Ib/II clinical study to explore the safety and efficacy of pomadomide in combination with rituximab and methotrexate (RPM) in newly diagnosed primary central nervous system lymphoma (PCNSL) subjects. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
PCNSL
What is being tested?
Pomalidomide, Rituximab and Methotrexate
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
43 participants
Where
1 siteChina
Study dates
31 Aug 2024to 31 Aug 2029
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histopathologically confirmed CD20+ diffuse large B-cell lymphoma (DLBCL).
  • The lesions were confined to the central nervous system, including the brain, spinal cord, eyes and meninges.
  • Through physical examination, imaging examination (including CT, MRI, PET-CT, etc.) and bone marrow puncture examination, it was confirmed that no parts other than the central nervous system were involved.
  • Patients who have not previously received chemotherapy or radiotherapy (except those with dexamethasone less than 10mg/ day (or equivalent dose) and duration less than 5 days).
  • Aged between 18 and 75 (inclusive).
  • Eastern Cooperative Oncology Group performance status 0 to 3.
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  • Measurable disease was defined as at least ≥1.0cm in short-diameter by enhanced MRI.
  • Life expectancy of ≥ 3 months (in the opinion of the investigator).
  • Participants must be able to understand and be willing to sign a written informed consent document.
  • Participants can follow up on schedule, communicate well with the investigator and complete the trial according to the trial regulations.
  • Women of reproductive potential must agree to use highly effective methods of birth control during the period of therapy and for 6 months after the last dose of the study drug. Men who are sexually active must agree to use highly effective contraception during the period of therapy and for 6 months after the last dose.

Who cannot join

  • Have systemic lymphoma disease.
  • Previous systemic or local treatment such as chemotherapy and/or radiotherapy and/or hematopoietic stem cell transplantation.
  • Previous or concurrent history of other malignant tumors requiring active therapy.
  • Chronic or currently active infectious diseases requiring systemic antibiotic, antifungal, or antiviral treatment (except EBV infections).
  • Accompanied by uncontrolled cardiovascular and cerebrovascular diseases, bleeding diseases, thrombotic diseases, connective tissue diseases and other diseases.
  • Patients with other uncontrolled diseases that the researchers deemed unsuitable for inclusion.
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  • Laboratory test values at screening (unless due to lymphoma) : White blood cell count < 3.5×109/L, neutrophils <1.5×109/L, platelets <80×109/L, hemoglobin <100g/L, ALT or AST 2.5 times higher than the upper limit of normal, bilirubin 1.5 times higher than the upper limit of normal, creatinine level 1.5 times higher than the upper limit of normal.
  • Presence of active hepatitis B virus(HBV) infection (HBsAg positive and HBV-DNA≥ 104), hepatitis C virus(HCV) infection, acquired and congenital immunodeficiency diseases include but not limited to HIV. HbsAg positive patients need to check HBV-DNA < 10^4 to be enrolled. In addition, if HBsAg is negative but HBcAb is positive (regardless of HBsAb status), HBV-DNA testing is also required, and HBV-DNA results < 10^4 are required to be enrolled and continue treatment and monitoring of HBV-DNA. HCV antibody positive patients need to check HCV-RNA quantitative DNA < 10^3 to be enrolled.
  • Pregnant or lactating women.
  • Those with a history of drug use or abuse were asked.
  • Patients with mental illness or other patients known or suspected to be unable to fully comply with the study protocol.
  • Known allergy to the investigational drug or its related ingredients.
  • Patients are unable to swallow capsules or suffer from diseases or conditions that severely affect gastrointestinal function, such as malabsorption syndrome, removal of the stomach or small intestine, or complete intestinal obstruction.
  • Patients who cannot withstand enhanced MRI.
  • Participants considered unsuitable for this clinical trial due to various other reasons.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Xianggui Yuan, Doctor contact

+8613989883884

yuanxg@zju.edu.cn

Wenbin Qian contact

+8613605801032

qianwb@zju.edu.cn

China1 site, 1 recruiting

  • 2nd Affiliated Hospital, School of Medicine, Zhejiang University

    Hanzhou, Zhejiang, 310009

    Wenbin Qian, +8613605801032, qianwb@zju.edu.cn

    Recruiting

Other trials in China

About this study

Official title: The Safety and Efficacy of Pomadomide in Combination With Rituximab and Methotrexate for Newly-diagnosed Primary Central Nervous System Lymphoma : A Prospective, Multicenter, Phase I/II Study

This is a prospective, multicenter, single-arm, open Phase Ib/II clinical study to explore the safety and efficacy of pomadomide in combination with rituximab and methotrexate (RPM) in newly diagnosed primary central nervous system lymphoma (PCNSL) subjects. The Phase I study is a dose escalation study, in which rituximab and methotrexate are fixed doses, and pomadomide is set into 3 dose groups: 3mg/d, 4mg/d and 5mg/d. In strict accordance with the "3+3" dose escalation principle, 3-6 subjects are to be recruited in each dose group, and each subject is to be observed for 1 cycle after treatment to determine MTD. Phase II study: RP2D is planned to be determined based on the Phase Ib study, with an additional 25 active participants enrolled to further evaluate efficacy and safety. Subjects with initial treatment of PCNSL who met the inclusion/exclusion criteria were screened, and after signing the informed consent letter, they received 4 courses of PRM regimen. The patients achieving CR or PR were consolidated by autologous transplantation consolidation regimen or the original regimen for 2 courses, and then were given pomadomide maintenance therapy for 12 cycles. Follow-ups should be taken up to the first 3 years.

Conditions
PCNSL
Keywords
PCNSL, Pomadomide, Rituximab, Methotrexate

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PomalidomideDrug

    3-5mg d1-d14 for 4-6 cycles, every 21 days as induction/consolidation chemotherapy, Then 3-5mg d1-d14 for 12 cycles, every 28 days as maintenance treatment.

  • RituximabDrug

    375mg/m2 intravenous infusion d1, every 3 weeks for 1 cycle, 4-6 cycles will be prescribed.

  • MethotrexateDrug

    3.5g/m2 intravenous infusion for 4 hours in d1, every 21 days for 1 cycle, 4-6 cycles will be prescribed.

Study groups in NCT06554561
Study groupRoleWhat they receive
PRM treatmentExperimentalExperimental arm will be treated with PRM regimen (pomadomide in combination with rituximab and methotrexate) for 4 cycles as initiate induction. If the patients achieved complete remission（CR）or partial remission（PR）, They would be consolidated by autologous transplantation consolidation regimen or the original regimen for additional 2 courses, and then were given pomadomide maintenance therapy for 12 cycles.
Receives: Drug: Pomalidomide; Drug: Rituximab; Drug: Methotrexate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. MTD

    MTD of pomalidomide when given in combination with rituximab and methotrexate determined by dose-limiting toxicities graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0

    Measured: 21days

  2. Objective response rate(ORR)

    The objective response rate is defined as the proportion of patients with a response of complete response(CR) or partial response(PR).

    Measured: 4 cycles of threatment

Secondary outcomes (2)

  1. Progression free survival

    From date of patients sign informed consent until the date of progression or death or the date of last follow-up time, whichever came first, assessed up to 3 years

    Measured: Time from registration to progression or death due to PCNSL, assessed up to 2 years

  2. Overall survival

    From date of patients sign informed consent until the date of progression or death or the date of last follow-up time, whichever came first, assessed up to 3 years

    Measured: Time from registration to death due to any cause, assessed up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Aug 2024
  2. Study start31 Aug 2024 (estimated)
  3. Primary completion31 Aug 2026 (estimated)
  4. Study completion31 Aug 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
43 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06554561
Sponsor's protocol ID
IR2024280
Status last verified
Aug 2024
First submitted
7 Aug 2024
Last updated
15 Aug 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Pomalidomide, Rituximab and Methotrexate in people with PCNSL, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Xianggui Yuan, Doctor (+8613989883884, yuanxg@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MTD (time frame: 21days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06554561.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2024.

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