Clinical trial · Interventional
Rituximab, Gemcitabine, and Vinorelbine in Treating Patients With Hodgkin Lymphoma That Has Relapsed or Not Responded to Treatment
A Pilot Study of Rituximab-Gemcitabine-Navelbine for Relapsed/Refractory Hodgkin's Lymphoma
- 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)
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cell-killing substances to them. Drugs used in chemotherapy, such as gemcitabine and vinorelbine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving rituximab together with gemcitabine and vinorelbine may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving rituximab together with gemcitabine and vinorelbine works in treating patients with Hodgkin lymphoma that has relapsed or not responded to treatment.
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 |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| gemcitabine hydrochloride | Drug | Gemcitabine | ALIAS |
| rituximab | Biological | Rituximab | ALIAS |
| vinorelbine ditartrate | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group 1 (eligible for SCT)
- description
- Patients receive rituximab IV, vinorelbine ditartrate IV over 6-10 minutes, and gemcitabine hydrochloride IV over 30 minutes on day 1 and pegfilgrastim subcutaneously on day 2. Treatment repeats every 14 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients with complete response (CR) or partial response (PR) undergo SCT.
- interventionNames
- Biological: rituximab
- Drug: gemcitabine hydrochloride
- Drug: vinorelbine ditartrate
- type
- EXPERIMENTAL
- label
- Group 2 (ineligible for SCT)
- description
- Patients receive rituximab, vinorelbine ditartrate, gemcitabine hydrochloride, and pegfilgrastim as in group 1. Patients with CR, PR, or stable disease after 3 courses continue to receive therapy in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Biological: rituximab
- Drug: gemcitabine hydrochloride
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Pathologically confirmed classical Hodgkin lymphoma, including 1 of the following cell types: * Nodular sclerosis * Mixed cellularity * Lymphocyte-rich * Lymphocyte-depleted * Measurable disease using the Cheson criteria, defined as ≥ 1 unidimensionally measurable lesion ≥ 2.0 cm by conventional techniques OR ≥ 1.0 cm by spiral CT scan * Progressive or relapsed disease after ≥ 1 prior line of combination chemotherapy * No known CNS metastasis PATIENT CHARACTERISTICS: * ECOG performance status 0-1 * ANC \> 1,500/mm\^3 * Platelet count \> 75,000/mm\^3 * Total bilirubin ≤ 2 mg/dL (unless due to hemolysis) * AST or ALT ≤ 2.5 times upper limit of normal * Creatinine normal OR creatinine clearance ≥ 50 mL/min * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No active hepatitis B infection * No known chronic hepatitis B carrier * No HIV positivity * No concurrent uncontrolled illness including, but not limited to, any of the following: * Symptomatic neurological illness * Active uncontrolled systemic infection considered opportunistic, life-threatening, or clinically significant at the time of study treatment * Symptomatic congestive heart failure * Unstable angina pectoris * Cardiac arrhythmia * Significant pulmonary disease or hypoxia * Psychiatric illness or social situation that would limit compliance with study requirements PRIOR CONCURRENT THERAPY: * See Disease Characteristics * More than 14 days since prior chemotherapy, immunotherapy, biological therapy, or investigational therapy and recovered * No prior gemcitabine hydrochloride, vinorelbine ditartrate, or rituximab * No other concurrent investigational or commercial agents or therapies with the intent to treat the malignancy
References
Publications (0)
Data not yet available