Phase 2
N=55
Cyclophosphamide, Rituximab, and Either Prednisone or Methylprednisolone in Treating Patients With Lymphoproliferative Disease After Solid Organ Transplantation
Lymphoproliferative Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00066469 ↗Enrolled (actual)
55
Serious AEs
3.7%
Results posted
Jan 2014
Primary outcome: Primary: Event-free Survival — 71 percentage of participants analyzed
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- rituximab (Biological); cyclophosphamide (Drug); methylprednisolone (Drug); prednisone (Drug)
- Age
- Pediatric, Adult
- Sex
- All
- Sponsor
- Children's Oncology Group
- Primary completion
- Oct 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Event-free Survival |
71 | — |
Summary
RATIONALE: Drugs used in chemotherapy such as cyclophosphamide, prednisone, and methylprednisolone use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining cyclophosphamide and either prednisone or methylprednisolone with rituximab may be effective in treating lymphoproliferative disease following organ transplantation.
PURPOSE: Phase II trial to study the effectiveness of combining cyclophosphamide and either prednisone or methylprednisolone with rituximab in treating patients who have Epstein-Barr virus-positive lymphoproliferative disease following organ transplantation.
Eligibility 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 central nervous system (CNS) disease, defined as positive cytology and/or radiographic evidence
PATIENT CHARACTERISTICS:
Age
- Under 31
Performance status
- Not specified
Life expectancy
- NF-PTLD patients:
- At least 8 weeks
Hematopoietic
- See Disease Characteristics
Hepatic
- See Disease Characteristics
Renal
- Not specified
Pulmonary
- See Disease Characteristics
Other
- Not pregnant or nursing
- Fertile patients must use effective contraception
- HIV negative
PRIOR CONCURRENT THERAPY:
Biologic therapy
- More than 1 month since prior rituximab
Chemotherapy
- More than 4 weeks since prior chemotherapy and recovered
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- See Disease Characteristics
Data sourced from ClinicalTrials.gov (NCT00066469). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.