Rituximab, Gemcitabine, and Vinorelbine in Treating Patients With Hodgkin Lymphoma That Has Relap… (NCT00881387) | Clinical Trial Compass
WithdrawnPhase 2
Rituximab, Gemcitabine, and Vinorelbine in Treating Patients With Hodgkin Lymphoma That Has Relapsed or Not Responded to Treatment
United States0Started 2009-02
Plain-language summary
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.
Who can participate
Age range
18 Years – 120 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 Cha…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.