Cyclophosphamide, Rituximab, and Either Prednisone or Methylprednisolone in Treating Patients With Lymphoproliferative Disease After Solid Organ Transplantation
NCT ID: NCT00066469
Last Updated: 2019-08-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
55 participants
INTERVENTIONAL
2004-04-30
2013-12-31
Brief Summary
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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.
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Detailed Description
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* 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.
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.
PROJECTED ACCRUAL: A 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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Cyclophosphamide, prednisone, rituximab
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
rituximab
Cycles 1 and 2 only: Given IV Incremental: First dosage: \< 21 years of age: 0.5mg/kg/hr (maximum of 50 mg/hr) for the 1st hour ≥ 21 years of age: 50 mg/hr for the 1st hour. Subsequent dosages: \< 21 years of age: 1.0mg/kg/hr (maximum of 50 mg/hr) for the 1st hour ≥ 21 years of age: 100 mg/hr for the 1st hour. Days 1, 8 and 15.
cyclophosphamide
Given IV over 30-60 minutes Dose 600 mg/m2 in 50-250 mL of normal saline (NS) or Dextrose-Water 5%(D5W) (at a maximum concentration of 20 mg/ml) over 30-60 minutes on day 1 of each cycle
methylprednisolone
Methylprednisolone 0.8 mg/kg IV over 12 hours on days 1,2,3,4 and 5 of each cycle.
prednisone
Dosage 1 mg/kg orally every 12 hours on days 1,2,3,4 and 5 of each cycle. Oral prednisone may be rounded up to the nearest 2.5 mg as necessary for tablet size
Interventions
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rituximab
Cycles 1 and 2 only: Given IV Incremental: First dosage: \< 21 years of age: 0.5mg/kg/hr (maximum of 50 mg/hr) for the 1st hour ≥ 21 years of age: 50 mg/hr for the 1st hour. Subsequent dosages: \< 21 years of age: 1.0mg/kg/hr (maximum of 50 mg/hr) for the 1st hour ≥ 21 years of age: 100 mg/hr for the 1st hour. Days 1, 8 and 15.
cyclophosphamide
Given IV over 30-60 minutes Dose 600 mg/m2 in 50-250 mL of normal saline (NS) or Dextrose-Water 5%(D5W) (at a maximum concentration of 20 mg/ml) over 30-60 minutes on day 1 of each cycle
methylprednisolone
Methylprednisolone 0.8 mg/kg IV over 12 hours on days 1,2,3,4 and 5 of each cycle.
prednisone
Dosage 1 mg/kg orally every 12 hours on days 1,2,3,4 and 5 of each cycle. Oral prednisone may be rounded up to the nearest 2.5 mg as necessary for tablet size
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
30 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Children's Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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Thomas G. Gross, MD, PhD
Role: STUDY_CHAIR
Nationwide Children's Hospital
Locations
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Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham
Birmingham, Alabama, United States
Phoenix Children's Hospital
Phoenix, Arizona, United States
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Southern California Permanente Medical Group
Downey, California, United States
Loma Linda University Cancer Institute at Loma Linda University Medical Center
Loma Linda, California, United States
Kaiser Permanente Medical Center - Oakland
Sacramento, California, United States
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States
Stanford Cancer Center
Stanford, California, United States
Children's Hospital Center for Cancer and Blood Disorders
Aurora, Colorado, United States
Alfred I. duPont Hospital for Children
Wilmington, Delaware, United States
Lee Cancer Care of Lee Memorial Health System
Fort Myers, Florida, United States
University of Florida Shands Cancer Center
Gainesville, Florida, United States
Nemours Children's Clinic
Jacksonville, Florida, United States
University of Miami Sylvester Comprehensive Cancer Center - Miami
Miami, Florida, United States
Sacred Heart Cancer Center at Sacred Heart Hospital
Pensacola, Florida, United States
All Children's Hospital
St. Petersburg, Florida, United States
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States
University of Illinois Cancer Center
Chicago, Illinois, United States
Children's Memorial Hospital - Chicago
Chicago, Illinois, United States
University of Chicago Cancer Research Center
Chicago, Illinois, United States
Simmons Cooper Cancer Institute
Springfield, Illinois, United States
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States
Kosair Children's Hospital
Louisville, Kentucky, United States
Tulane Cancer Center Office of Clinical Research
Alexandria, Louisiana, United States
C.S. Mott Children's Hospital at University of Michigan Medical Center
Ann Arbor, Michigan, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Butterworth Hospital at Spectrum Health
Grand Rapids, Michigan, United States
CCOP - Kalamazoo
Kalamazoo, Michigan, United States
Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesota, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, United States
University of Mississippi Cancer Clinic
Jackson, Mississippi, United States
Ellis Fischel Cancer Center at University of Missouri - Columbia
Columbia, Missouri, United States
Children's Mercy Hospital
Kansas City, Missouri, United States
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
St Louis, Missouri, United States
UNMC Eppley Cancer Center at the University of Nebraska Medical Center
Omaha, Nebraska, United States
Sunrise Hospital and Medical Center
Las Vegas, Nevada, United States
Hackensack University Medical Center Cancer Center
Hackensack, New Jersey, United States
Mount Sinai Medical Center
New York, New York, United States
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
New York, New York, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States
SUNY Upstate Medical University Hospital
Syracuse, New York, United States
New York Medical College
Valhalla, New York, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States
Blumenthal Cancer Center at Carolinas Medical Center
Charlotte, North Carolina, United States
Akron Children's Hospital
Akron, Ohio, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Rainbow Babies and Children's Hospital
Cleveland, Ohio, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
Oklahoma University Cancer Institute
Oklahoma City, Oklahoma, United States
Legacy Emanuel Hospital and Health Center and Children's Hospital
Portland, Oregon, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
East Tennessee Children's Hospital
Knoxville, Tennessee, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Driscoll Children's Hospital
Corpus Christi, Texas, United States
Medical City Dallas Hospital
Dallas, Texas, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Methodist Children's Hospital of South Texas
San Antonio, Texas, United States
Primary Children's Medical Center
Salt Lake City, Utah, United States
Fletcher Allen Health Care - University Health Center Campus
Burlington, Vermont, United States
Inova Fairfax Hospital
Falls Church, Virginia, United States
Children's Hospital of The King's Daughters
Norfolk, Virginia, United States
Children's Hospital and Regional Medical Center - Seattle
Seattle, Washington, United States
West Virginia University Health Sciences Center - Charleston
Charleston, West Virginia, United States
Marshfield Clinic - Marshfield Center
Marshfield, Wisconsin, United States
Westmead Institute for Cancer Research at Westmead Hospital
Westmead, New South Wales, Australia
Royal Children's Hospital
Brisbane, Queensland, Australia
Princess Margaret Hospital for Children
Perth, Western Australia, Australia
University of Alberta Hospital
Edmonton, Alberta, Canada
Children's & Women's Hospital of British Columbia
Vancouver, British Columbia, Canada
CancerCare Manitoba
Winnipeg, Manitoba, Canada
IWK Health Centre
Halifax, Nova Scotia, Canada
Hospital for Sick Children
Toronto, Ontario, Canada
Montreal Children's Hospital at McGill University Health Center
Montreal, Quebec, Canada
Hopital Sainte Justine
Montreal, Quebec, Canada
Starship Children's Health
Auckland, , New Zealand
Christchurch Hospital
Christchurch, , New Zealand
Countries
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References
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Gross TG, Orjuela MA, Perkins SL, Park JR, Lynch JC, Cairo MS, Smith LM, Hayashi RJ. Low-dose chemotherapy and rituximab for posttransplant lymphoproliferative disease (PTLD): a Children's Oncology Group Report. Am J Transplant. 2012 Nov;12(11):3069-75. doi: 10.1111/j.1600-6143.2012.04206.x. Epub 2012 Aug 6.
Other Identifiers
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CDR0000316241
Identifier Type: OTHER
Identifier Source: secondary_id
COG-ANHL0221
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-2012-02544
Identifier Type: OTHER
Identifier Source: secondary_id
ANHL0221
Identifier Type: -
Identifier Source: org_study_id
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