Combination therapy for Waldenström's Macroglobulinemia

A Multicenter Prospective Phase II Study of Rituximab Combined, Lenalidomide, Dexamethasone Followed by Lenalidomide Maintenance in Patients With Newly Diagnosed Waldenström's Macroglobulinemia

This study is testing a new combination of treatments for people newly diagnosed with Waldenström's Macroglobulinemia to see if it helps them respond better and stay healthy.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 54 (estimated)
• Ages: 19 Years and up
• Sex: All
• Sponsor: Kosin University Gospel Hospital (other)
• Drugs / interventions: rituximab, chemotherapy
• Locations: 1 site (Busan, Sue-gu)
• Trial ID: NCT03697356 on ClinicalTrials.gov

What this trial studies

This phase II clinical trial evaluates the effectiveness of a combination treatment regimen involving rituximab, bortezomib, lenalidomide, and dexamethasone, followed by lenalidomide maintenance therapy in patients newly diagnosed with Waldenström's Macroglobulinemia. The study aims to improve overall response rates and assess the safety of this treatment approach. Participants will be monitored for measurable disease and must meet specific eligibility criteria, including performance status and organ function. The trial is conducted at Kosin University Gospel Hospital in Korea.

Who should consider this trial

Good fit: Ideal candidates are adults aged 19 and older with a confirmed diagnosis of Waldenström's Macroglobulinemia and measurable disease.

Not a fit: Patients with prior treatment experience for Waldenström's Macroglobulinemia or those with severe comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve response rates and outcomes for patients with Waldenström's Macroglobulinemia.

How similar studies have performed: Previous studies have shown promising results with similar combination therapies in treating Waldenström's Macroglobulinemia, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

1. Clinicopathological diagnosis of Waldenstrom's Macroglobulinemia
2. Patients who meet criteria for treatment using consensus panel criteria from the Second International Workshop on Waldenstrom's macroglobulinemia
3. Male or female patients aged ≥19 years
4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
5. Patients must have measurable disease, IgM \> 0.5g/dL
6. Appropriate bone marrow, liver, and kidney function
7. Patients who are able to understand oral and written instructions and who are able to comply with all requirements
8. Patients who provided agreement of subject consent (ICF) prior to initiation of clinical trial.
9. Female patients had to be post-menopausal for ≥1 year, surgically sterile, or practicing an effective method of birth control (as described in the protocol), and have a negative serum beta-human chorionic gonadotropin or urine pregnancy test at screening; they also had to agree to continue using birth control measures for ≥6 months after terminating treatment. Male patients had to agree to use an acceptable method of contraception for the duration of the study.

Exclusion Criteria:

1. Central nervous system involvement central nervous system (CNS) involvement by Waldenström's macroglobulinemia
2. Patients who have received rituximab, lenalidomide, or bortezomib
3. Patients who are allergic or hypersensitive to mouse (murine), chimeric, human or humanized proteins, lenalidomide, bortezomib
4. One of the following labs or more:

   * Absolute neutrophil count (ANC) \<1,000 / μL
   * Platelet count \<75,000 cells / μL when not transfused
   * Serum AST / ALT\> 3 times the upper limit of normal
5. Renal failure requiring hemodialysis or peritoneal dialysis
6. Patients with uncontrolled severe heart disease
7. Patients who can not or do not want antithrombotic therapy
8. Patient has more than Grade 2 peripheral neuropathy on clinical examination during the screening period
9. Patient with a history of stroke or cerebral hemorrhage within 12 months bofore signing ICF
10. Patients who have been diagnosed with a currently unadjusted severe infection
11. Patients with known human immunodeficiency virus (HIV), hepatitis C infection
12. Patients diagnosed with malignancy within 5 years before signing ICF
13. Pregnant or lactating patients
14. Requires treatment with a strong cytochrome P450 (CYP) 3A inhibitor
15. Patients with acute diffuse invasive pulmonary disease and cardiovascular disease

Where this trial is running

Busan, Sue-gu

• Kosin University Gospel Hospital — Busan, Sue-gu, South Korea (RECRUITING)

Study contacts

• Principal investigator: HoSup Lee — KUGH
• Study coordinator: HoSup Lee, MD, PhD

Conditions: Waldenström's Macroglobulinemia