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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03335098
Other study ID # 1605-137-765
Secondary ID
Status Recruiting
Phase Phase 2
First received November 4, 2017
Last updated November 6, 2017
Start date November 21, 2016
Est. completion date December 2020

Study information

Verified date November 2017
Source Seoul National University Hospital
Contact Eun-Hee Park, CRN
Phone +82-10-3349-1453
Email eh.park@daum.net
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is a phase 2, single-arm, open-label, multi-institutional trial to evaluate the efficacy of combination therapy of bortezomib, thalidomide, and dexamethasone in patients with newly diagnosed Waldenstrom's macroglobulinemia and lymphoplasmacytic lymphoma.


Recruitment information / eligibility

Status Recruiting
Enrollment 15
Est. completion date December 2020
Est. primary completion date December 2020
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility Inclusion Criteria:

- Age of 19 or older

- Newly diagnosed Waldenstrom's macroglobulinemia or lymphoplasmacytic lymphoma

- Previously untreated with chemotherapy

- ECOG performance status of 2 or lesser

- Peripheral blood white blood cell count = 3,500/uL

- Peripheral blood neutrophil count = 1,000/uL

- Peripheral blood platelet count = 20,000/uL

- Peripheral blood hemoglobin = 6.0g/dL

- Serum total bilirubin = 2.0 mg/dL

- Serum aspartate aminotransferase = 2.5 x (upper normal limit)

- Serum alanine aminotransferase = 2.5 x (upper normal limit)

Exclusion Criteria:

- Diagnosed with other malignancy within 5 years before enrollment

- Prior hematopoietic stem cell transplantation

- Prior organ transplantation

- Uncontrolled central nervous system involvement

- Congenital immunodeficiency

- Acquired immune deficiency syndrome (AIDS)

- Pregnancy

- Uncontrolled epilepsy

- Uncontrolled psychological disease

- Peripheral neuropathy of grade 3 or higher

Study Design


Intervention

Drug:
Bortezomib
Six 4-week cycles

Locations

Country Name City State
Korea, Republic of Seoul National University Bundang Hospital Seongnam
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (2)

Lead Sponsor Collaborator
Seoul National University Hospital Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Overall response rate Overall response rate as per Lugano criteria at 3 years
Secondary Progression-free survival Time from enrollment to disease progression or death from any cause at 3 years
Secondary Overall survival Time from enrollment to death from any cause at 3 years
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