CompletedPhase 2

Rituximab & Combination Chemotherapy Followed by Transplantation in Relapsed or Refractory Non-Hodgkin's Lymphoma

United States44 participantsStarted 2000-09-01

Plain-language summary

RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation or bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of rituximab and combination chemotherapy followed by bone marrow or peripheral stem cell transplantation in treating patients who have relapsed or refractory non-Hodgkin's lymphoma.

Who can participate

Age range

19 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: * Diagnosis of CD20-positive B-cell non-Hodgkin's lymphoma * Transplantation candidate * Primary induction failure * Chemotherapy refractory disease * Received at least 3 prior chemotherapy regimens or diagnosis of mantle cell lymphoma * Age 19 and over * Performance status: WHO 0-2 * Life expectancy at least 6 months * Absolute neutrophil count at least 1,000/mm3 (unless due to lymphomatous involvement of the marrow) * Platelet count more than 50,000/mm3 (unless due to lymphomatous involvement of the marrow) * Hemoglobin more than 9.0 g/dL (unless due to lymphomatous involvement of the marrow) * Fertile patients must use effective contraception * Concurrent non-steroidal hormones for non-lymphoma-related conditions (e.g., insulin for diabetes) allowed Exclusion Criteria: * No other concurrent chemotherapy * No concurrent corticosteroids except for transient control or prevention of nausea or vomiting * No concurrent external beam radiotherapy during transplantation therapy * No other concurrent antitumoral or investigational agents * No history of T-cell lymphoma * No relapse or progression after rituximab therapy within 3 months before transplantation * No serious disease or condition that would preclude study * Not pregnant or nursing/negative pregnancy test

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

100 day (complete + partial) response rate

Timeframe: 100 days

Trial details

NCT IDNCT00007852

SponsorUniversity of Nebraska

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2002-01-01

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