Clinical trial · Interventional
GP2013 in Japanese Patients With CD20 Positive Low Tumor Burden Indolent B-cell Non-Hodgkin's Lymphoma
Phase I Trial to Assess the Safety and Pharmacokinetics of GP2013 Monotherapy Administered Weekly in Japanese Patients With CD20 Positive Low Tumor Burden Indolent B-cell Non-Hodgkin's Lymphoma
NCT01933516CI-TRIAL-00033978completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate safety and pharmacokinetic of GP2013 in Japanese patients with CD20 positive low tumor burden indolent B-cell NHL under weekly dosing schedule.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Indolent B-cell Non-Hodgkin's Lymphoma | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GP2013 | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- GP2013
- interventionNames
- Drug: GP2013
Primary outcomes (7)
- measure
- To evaluate safety of GP2013
- timeFrame
- 12 weeks
- description
- Adverse events, laboratory abnormalities
- measure
- Area under the curve calculated from start of dose to the end of the dosing interval (tau) of GP2013
- timeFrame
- 12 weeks
- measure
- Maximum observed concentration of GP2013
- timeFrame
- 12 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Patient with CD20 positive low tumor burden indolent B-cell non- Hodgkin's lymphoma. * Patient with at least one measurable lesion. * Patient with ECOG performance status 0 or 1. Exclusion Criteria: * Patient who has received radiotherapy within the last 28 days prior to administration, or are not recovered from previous radiotherapy. * Patient who has received immunotherapy, chemotherapy, antibodies and experimental treatment within the last 28 days prior to administration, or are not recovered from previous therapy. * Patient who has mAb therapy other than rituximab as prior line of therapy. * Patient with evidence of any uncontrolled, acute or chronic active infection (viral, bacterial or fungal). * Patient with any other malignancy within 5 years prior to date of screening, with the exception of adequately treated in situ carcinoma of the cervix uteri, basal or squamous cell carcinoma or nonmelanomatous skin cancer. Other protocol-defined inclusion/exclusion criteria may apply.
References
Publications (0)
Data not yet available
No reference posted for this study.