Clinical trial · Interventional
Gemcitabine for Marginal Zone Lymphoma
Phase II Study of Gemcitabine in Patients With Advanced Stage Marginal Zone B-cell Lymphoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): poor accrual and response less than expected on interim analysis
Summary
Brief summary (as posted)
Marginal zone lymphoma, one of the indolent lymphoma, is believed to be incurable with chemotherapy. Thus the investigators need a novel agent for marginal zone lymphoma. Gemcitabine has been tried as one of salvage chemotherapy regimen and has been shown to have anti-lymphoma activity. To the investigators' knowledge, there has been no trial of gemcitabine for marginal zone lymphoma. Thus the investigators made a plan to investigate the role of gemcitabine in marginal zone lymphoma.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Marginal Zone Lymphoma | Marginal Zone Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Non-Hodgkin's Lymphoma | Non-Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| gemcitabine | Drug | Gemcitabine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Gemcitabine
- description
- * histologically confirmed marginal zone lymphoma * gemcitabine 1,250 mg/m2 on days 1 and 8 of each cycle, repeated every 3 weeks and continued for 6 cycles, until disease progression, withdrawal due to toxicity, or withdrawal of consent.
- interventionNames
- Drug: gemcitabine
Primary outcomes (1)
- measure
- response rate
- timeFrame
- CR+PR with study therapy
Secondary outcomes (1)
- measure
- safety and tolerability of the treatment
- timeFrame
- toxicity due to stdy drug
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
* Histologically confirmed marginal zone B-cell lymphoma
* Performance status (ECOG) ≤3
* Age ≥ 18
* At least one or more bidimensionally measurable lesion(s):
* 2 cm by conventional CT
* 1 cm by spiral CT
* skin lesion (photographs should be taken)
* measurable lesion by physical examination
* Laboratory values:
* Cr \< 2.0 mg% or Ccr \> 60 ml/min
* Transaminase \< 3 X upper normal value
* Bilirubin \< 2 mg%
* ANC \> 1500/ul, platelet \> 75,000/ul
* Informed consent
* Ann Arbor stage III or IV
Exclusion Criteria:
* Any other malignancies within the past 5 years except skin basal cell ca or CIS of cervix
* Serious comorbid diseases
* Pregnancy or breast feedingReferences
Publications (0)
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