Chemotherapy Before Autologous Stem Cell Transplantation +/- Rituximab in Relapsed or Refractory … (NCT00078949) | Clinical Trial Compass
CompletedPhase 3
Chemotherapy Before Autologous Stem Cell Transplantation +/- Rituximab in Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma
United States, Australia, Canada849 participantsStarted 2003-08-27
Plain-language summary
RATIONALE: Drugs used in chemotherapy, such as dexamethasone, cisplatin, gemcitabine, and cytarabine, work in different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with autologous stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Monoclonal antibodies, such as rituximab, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Giving rituximab as maintenance therapy after stem cell transplantation may kill any remaining cancer cells. It is not yet known which salvage chemotherapy regimen is more effective before autologous stem cell transplantation in treating relapsed or refractory non-Hodgkin's lymphoma.
PURPOSE: This randomized phase III trial is studying salvage chemotherapy using dexamethasone, cisplatin, and gemcitabine to see how well it works compared to dexamethasone, cisplatin, and cytarabine given before autologous stem cell transplantation in treating patients with relapsed or refractory aggressive non-Hodgkin's lymphoma. This trial also is studying giving rituximab as maintenance therapy to see how well it works compared to no further therapy after stem cell transplantation. Rituximab was added to both salvage treatment arms for CD20+ patients in a protocol amendment in 2005.
Who can participate
Age range
16 Years – 65 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:
* Histologically confirmed aggressive non-Hodgkin's lymphoma of 1 of the following subtypes:
* Diffuse large cell lymphoma (includes primary mediastinal B-cell lymphoma and T-cell-rich B-cell lymphoma)
* Prior indolent lymphoma (e.g., follicular center cell lymphoma; marginal zone lymphoma, including extranodal mucosa-associated lymphoid tissue \[MALT\] lymphoma; and lymphoplasmacytoid lymphoma) with transformation to diffuse large B-cell lymphoma at relapse
* Must be histologically confirmed
* No transformed lymphoma at diagnosis with subsequent indolent histology without transformation at relapse
* Peripheral T-cell lymphoma
* Anaplastic large cell lymphoma
* Small noncleaved Burkitt-like lymphoma
* T-cell or B-cell lineage confirmed by immunohistochemistry
* Clinically or radiologically documented disease meeting either of the following criteria:
* Measurable disease, defined as at least 1 bidimensionally measurable site of disease using clinical exam, CT scan, or MRI
* Lymph nodes must be \> 1.5 cm by physical exam or CT scan
* Other non-nodal lesions must be ≥ 1.0 cm by physical exam, CT scan, or MRI
* Bone lesions are not considered measurable
* Evaluable disease, defined as only nonmeasurable disease, including any of the following:
* Marrow infiltration
* Cytology-confirmed ascites or effusions
* Bony involvement
* Enlarged liver or spleen
* Unidimensionally measurable intrathoracic o…
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
Response Rate of Patients After 2 Courses of Chemotherapy
Timeframe: After 2 cycle of treatment
2
Transplantation Rate of Patients After 2 Courses of Chemotherapy
Timeframe: During period 1 (salvage chemotherapy)
3
Event-free Survival of Patients on Maintenance Randomization (Period 2)