Trial Information

Summary: A Phase II Study of the Combination of Cyclophosphamide, Prednisone and Rituximab (CPR) in Children, Adolescents and Young Adults with CD20 Positive Post-Transplant Lymphoproliferative Disease (PTLD) following Solid Organ Transplantation (SOT)

What is the purpose of this study?
The goals of this study are:

1. To find out if rituximab, in combination with the commonly used cancer drugs, cyclophosphamide and prednisone, is effective in treating Post-Transplant Lymphoproliferative Disease (PTLD) after a solid organ transplant.
2. To find out what the effects, good and bad, are for this drug combination.
3. To study the biologic and genetic features of PTLD, including looking at the genes to see if they can predict how patients will respond to treatment on this study.
4. To get a sense of how many patients less than 31 years old have PTLD after a solid organ transplant.

Who will be included in this study?
Patients who are under 31 years old who have post-transplant lymphoproliferative disease (PTLD) following a solid organ transplant (SOT) may be eligible to participate in this clinical trial.

What is involved?
Participants will be treated on this study for up to 16 weeks. However, participants will continue to have follow-up for at least two years after treatment. The Children's Oncology Group would like to continue to follow patients for about 5 years after the study closes to new patients.

Patients who take part in this study will have the following tests and procedures:

  • Physical exam
  • Medical history
  • Blood tests
  • Bone marrow biopsy and aspirate
  • Lumbar puncture
  • Optional research studies

What are the benefits?
Participants who agree to take part in this research study may or may not experience a direct medical benefit. The information learned from this research study may benefit other patients with post-transplant lymphoproliferative disease following solid organ transplantation in the future.

Will I get all the facts about the study?
Parents interested in having their child participate will be scheduled with a physician who will thoroughly explain all of the details of the study. The physician will review the consent form with the parent/patient and will be sure that all questions are answered. The consent form goes over all of the procedures, the risks, the benefits, the compensation, who to contact with questions or concerns and more. Study procedures will not begin until a parent/guardian has signed this form and, if of age, the child has given at minimum his/her verbal agreement.

What are the risks?
A detailed list of side effects will be provided to those patients interested in knowing more about the study.

Who should I contact for more information?

Contact:

Rebecca Turner, CCRP
Cincinnati Children's Hospital Medical Center/Cincinnati Children's Research Foundation
Division of Hematology/Oncology, MLC 11013
3333 Burnet Ave.
Cincinnati, OH 45229-3039
Telephone: 513-636-2799
Email:

Profile Page: Cincinnati Children's Hospital Medical Center/Cincinnati Children's Research Foundation, Cincinnati, OH

If you would like to learn more about participating in this study, please send an e-mail message using the form below.

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Trial listings updated: June 1, 2008 at 5:45:43 AM


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