Gemcitabine and Bendamustine in Patients With Relapsed or Refractory Hodgkin's Lymphoma (NCT01535924) | Clinical Trial Compass
CompletedPhase 1/2
Gemcitabine and Bendamustine in Patients With Relapsed or Refractory Hodgkin's Lymphoma
United States26 participantsStarted 2012-02-09
Plain-language summary
This phase I/II trial studies the side effects and best dose of bendamustine hydrochloride when given together with gemcitabine hydrochloride and to see how well it works in treating patients with relapsed or refractory Hodgkin lymphoma. Drugs used in chemotherapy, such as gemcitabine hydrochloride and bendamustine hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug, combination chemotherapy, may kill more cancer cells.
Who can participate
Age range
18 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.
Inclusion Criteria:
* Histologically documented Classical Hodgkin's lymphoma that is recurrent or refractory after standard chemotherapy; core biopsies are acceptable if they contain adequate tissue for primary diagnosis and immunophenotyping; bone marrow biopsies as the sole means of diagnosis are not acceptable
* Patients with Hodgkin's lymphoma may have one of the following World Health Organization subtypes:
* Nodular sclerosis Hodgkin's lymphoma
* Lymphocyte-rich Hodgkin's lymphoma
* Mixed cellularity Hodgkin's lymphoma
* Lymphocyte depletion Hodgkin's lymphoma
* Nodular lymphocyte predominant Hodgkin's lymphoma
* Patients must have relapsed or progressed after at least one prior therapy
* Patients with relapsed or refractory disease following stem cell transplantation are permitted
* No prior treatment with bendamustine; prior therapy with gemcitabine is permitted
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
* Measurable disease must be present either on physical examination or imaging studies; non-measurable disease alone is not acceptable
* Measurable disease: lesions that can be accurately measured in at least two dimensions as \>= 1.0 x 1.0 cm by computerized tomography (CT), PET/CT (positron emission tomography/CT), or magnetic resonance imaging (MRI)
* Non-measurable disease: all other lesions, including small lesions (less than 1.0 x 1.0 cm) and truly non-measurable lesions; lesions that are considered non-measurable include the …
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.
What they're measuring
1
Adverse Events in Terms of Dose-limiting Toxicity (DLT) and MTD of Bendamustine Hydrochloride (Phase I)