Beta-Glucan and Rituximab in Treating Young Patients With Relapsed or Progressive Lymphoma or Leu… (NCT00087009) | Clinical Trial Compass
TerminatedPhase 1
Beta-Glucan and Rituximab in Treating Young Patients With Relapsed or Progressive Lymphoma or Leukemia, or Lymphoproliferative Disorder Related to Donor Stem Cell Transplantation
Stopped: Lack of Accrual
United States3 participantsStarted 2004-05
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. Beta-glucan may increase the effectiveness of rituximab by making cancer cells more sensitive to the monoclonal antibody.
PURPOSE: This phase I trial is studying the side effects and best dose of beta-glucan when given together with rituximab in treating young patients with relapsed or progressive lymphoma or leukemia or with lymphoproliferative disorder related to donor stem cell transplantation.
Who can participate
Age range
21 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 diagnosis of 1 of the following:
* B-cell non-Hodgkin's lymphoma (NHL)
* Hodgkin's lymphoma
* Post-transplant lymphoproliferative disorder (PTLD)
* Lymphoblastic leukemia
* CD20-positive disease verified by immunophenotyping at original diagnosis, disease relapse, or disease progression
* Refractory to conventional therapy, defined as 1 of the following:
* Medically refractory HIV-associated NHL
* Refractory or recurrent lymphoblastic leukemia
* PTLD
* In \> first relapse or progression of B-cell NHL or Hodgkin's lymphoma
* Measurable (CT scan or MRI) or evaluable (marrow metastases or circulating lymphoblasts) disease within 4 weeks after completion of prior systemic (including systemic steroids) therapy
PATIENT CHARACTERISTICS:
Age
* Under 22
Performance status
* Not specified
Life expectancy
* Not specified
Hematopoietic
* Absolute neutrophil count \> 500/mm\^3\*
* Platelet count \> 10,000/mm\^3\* NOTE: \*Excluding patients with PTLD or CD20-positive lymphoblastic leukemia
Hepatic
* Hepatic toxicity ≤ grade 2
Renal
* Creatinine clearance ≥ 60 mL/min
* Renal toxicity ≤ grade 2
Cardiovascular
* Cardiac toxicity ≤ grade 2
Pulmonary
* Pulmonary toxicity ≤ grade 2
Immunologic
* Human anti-mouse antibody (HAMA) ≤ 1,000 units/mL
* Human anti-chimeric antibody titer negative
* No active, life-threatening infections except Epstein-Barr virus-associated lymphoproliferative disorder
* No history…
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.