Actively Recruiting

Phase 1
Phase 2
Age: 18Years - 75Years
All Genders
ID06554561

Safety and Efficacy of Pomadomide With Rituximab and Methotrexate for Newly Diagnosed Primary CNS Lymphoma: A Phase I/II Multicenter Study

Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2024-08-15

43

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and efficacy of pomadomide combined with rituximab and methotrexate (PRM regimen) in people newly diagnosed with primary central nervous system lymphoma (PCNSL), a type of lymphoma confined to the brain, spinal cord, eyes, or meninges. This Phase Ib/II, prospective, multicenter, open-label study includes a dose escalation phase to find the maximum tolerated dose of pomadomide and a second phase to further assess treatment effects and safety in more participants. Participants receive induction treatment with the PRM regimen for 4 cycles, where pomadomide doses range from 3mg to 5mg once daily for 14 days every 21 days, rituximab given by intravenous infusion at 375mg/m2 on day 1 every 3 weeks, and methotrexate given by intravenous infusion at 3.5g/m2 over 4 hours on day 1 every 21 days. Those who achieve complete or partial remission then receive consolidation treatment either with autologous transplantation or the original regimen for 2 additional cycles, followed by pomadomide maintenance therapy for 12 cycles. Throughout the study, participants undergo assessments including imaging scans to measure disease response and laboratory tests to monitor health. The main outcomes measured are the maximum tolerated dose of pomadomide and the objective response rate after 4 cycles. Secondary outcomes include progression-free survival for up to 2 years and overall survival for up to 3 years. Follow-up care and evaluations continue for up to 3 years after treatment to monitor long-term effects and disease status.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histopathologically confirmed CD20+ diffuse large B-cell lymphoma (DLBCL).
  • Lesions confined to the central nervous system including brain, spinal cord, eyes, and meninges.
  • No involvement outside the central nervous system confirmed by exams and bone marrow biopsy.
  • No prior chemotherapy or radiotherapy except dexamethasone less than 10mg/day for under 5 days.
  • Age between 18 and 75 years inclusive.
  • Eastern Cooperative Oncology Group performance status 0 to 3.
  • Measurable disease with at least 1.0 cm short diameter by enhanced MRI.
  • Life expectancy of 3 months or more.
  • Ability to understand and willing to sign informed consent.
  • Ability to follow up and complete trial procedures.
  • Women and men of reproductive potential agree to use effective contraception during therapy and 6 months after last dose.
Not Eligible

You will not qualify if you...

  • Presence of systemic lymphoma disease.
  • Prior systemic or local lymphoma treatments including chemotherapy, radiotherapy, or stem cell transplantation.
  • History of other active malignant tumors needing treatment.
  • Active infections requiring systemic antibiotic, antifungal, or antiviral treatment (except EBV).
  • Uncontrolled cardiovascular, cerebrovascular, bleeding, thrombotic, or connective tissue diseases.
  • Other uncontrolled diseases deemed unsuitable by researchers.
  • Abnormal lab values at screening not due to lymphoma (low blood counts, elevated liver or kidney markers).
  • Active hepatitis B or C infection or immunodeficiency diseases including HIV.
  • Pregnant or breastfeeding women.
  • History of drug abuse.
  • Mental illness or inability to comply with study protocol.
  • Allergy to study drugs or ingredients.
  • Inability to swallow capsules or severe gastrointestinal conditions.
  • Unable to undergo enhanced MRI.
  • Other reasons making participant unsuitable for the trial.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to approximately 14 to 18 months depending on response and treatment cycles

Participants receive pomalidomide in combination with rituximab and methotrexate as induction, consolidation, and maintenance therapy for primary CNS lymphoma.

4 to 6 cycles every 21 days for induction/consolidation, followed by 12 cycles every 28 days for maintenance

Trial Site Locations

Total: 1 location

1

2nd Affiliated Hospital, School of Medicine, Zhejiang University

Hanzhou, Zhejiang, China, 310009

Actively Recruiting

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Research Team

X

Xianggui Yuan, Doctor

W

Wenbin Qian

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

Frequently Asked Questions

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