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Phase II Study of Cyclophosphamide, Rituximab, and Prednisone or Methylprednisolone in Patients With CD20-Positive Post-Transplant Lymphoproliferative Disease After Solid Organ Transplantation
Alternate Title Basic Trial Information Objectives Entry Criteria Expected Enrollment Outcomes Outline Trial Contact Information Registry Information
Alternate Title
Cyclophosphamide, Rituximab, and Either Prednisone or Methylprednisolone in Treating Patients With Lymphoproliferative Disease After Solid Organ Transplantation
Basic Trial Information
Phase | Type | Status | Age | Protocol IDs |
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Phase II | Treatment | Closed | Under 31 | COG-ANHL0221 NCT00066469, ANHL0221 |
Objectives - Determine the safety and toxicity of cyclophosphamide, rituximab, and prednisone or methylprednisolone in patients with CD20-positive and Epstein-Barr virus-positive post-transplant lymphoproliferative disease (PTLD) after solid organ transplantation.
- Determine the 2-year event-free survival, defined as alive and in continuous complete remission with a functioning original allograft, of patients treated with this regimen.
- Determine the response rate in patients treated with this regimen.
- Determine the PTLD gene expression profile by microarray analysis and fluorescent in situ hybridization in patients treated with this regimen.
- Determine the accrual rate of patients to this study.
Entry Criteria Disease Characteristics:
- Histologically confirmed post-transplant lymphoproliferative disease (PTLD)
- Presents with 1 of the following:
- Fulminant PTLD (F-PTLD)
- Fever greater than 38°C
- Hypotensive (for age)
- Evidence of multiple organ involvement/failure, including at least 2 of the following:
- Marrow (including pancytopenia without detectable B-cell proliferation)
- Liver (coagulopathy, transaminitis, and/or hyperbilirubinemia)
- Lungs (interstitial pneumonitis with or without pleural effusions)
- Gastrointestinal tract hemorrhage
- Non-fulminant PTLD (NF-PTLD)
- Does not meet the above F-PTLD criteria
- Considered medically refractory to reduced immune suppression (50% or more reduction of immunosuppression) for at least 1 week
- CD20 positive AND Epstein-Barr virus positive
- Must have received prior solid organ transplantation
- Must have residual disease after biopsy and/or surgery
- No PTLD CNS disease, defined as positive cytology and/or radiographic evidence
Prior/Concurrent Therapy:
Biologic therapy - More than 1 month since prior rituximab
Chemotherapy - More than 4 weeks since prior chemotherapy and recovered
Endocrine therapy Radiotherapy Surgery - See Disease Characteristics
Patient Characteristics:
Age Performance status Life expectancy Hematopoietic - See Disease Characteristics
Hepatic - See Disease Characteristics
Renal Pulmonary - See Disease Characteristics
Other - Not pregnant or nursing
- Fertile patients must use effective contraception
- HIV negative
Expected Enrollment 60A total of 60 patients (50 with non-fulminant post-transplant lymphoproliferative disease [PTLD] and 10 fulminant PTLD) will be accrued for this study within 2.5-3 years. Outcomes Primary Outcome(s)Event-free survival at 2 years
Outline This is a multicenter study. Patients receive cyclophosphamide IV over 30-60 minutes on day 1 and oral prednisone or methylprednisolone IV twice daily on days 1-5. During courses 1 and 2 only, patients also receive rituximab IV over 2-5 hours on days 1, 8, and 15. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression, a new primary or secondary malignancy, or unrelated disease. After finishing study treatment, patients are followed periodically for at least 5 years.
Trial Contact Information
Trial Lead Organizations Children's Oncology Group | | | Thomas Gross, MD, PhD, Protocol chair | | | |
Registry Information | | Official Title | | 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) | | Trial Start Date | | 2004-04-19 | | Trial Completion Date | | 2008-07-03 (estimated) | | Registered in ClinicalTrials.gov | | NCT00066469 | | Date Submitted to PDQ | | 2003-06-18 | | Information Last Verified | | 2008-08-20 | | NCI Grant/Contract Number | | CA98543 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. Back to Top |
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