DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Cyclophosphamide, Rituximab, and Either Prednisone or Methylprednisolone in Treating Patients With Lymphoproliferative Disease After Solid Organ Transplantation

Information source: Children's Oncology Group
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Lymphoproliferative Disorder

Intervention: rituximab (Biological); cyclophosphamide (Drug); methylprednisolone (Drug); prednisone (Drug)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: Children's Oncology Group

Official(s) and/or principal investigator(s):
Thomas G. Gross, MD, PhD, Study Chair, Affiliation: Nationwide Children's Hospital


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.

Clinical Details

Official title: Phase II Study of Cyclophosphamide, Prednisone and Rituximab (CPR) in Children, Adolescents and Young Adults With B-lymphocyte Antigen CD20 (CD20) Positive Post-Transplant Lymphoproliferative Disease (PTLD) Following Solid Organ Transplantation (SOT)

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Event-free Survival

Detailed description: 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.

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.


Minimum age: N/A. Maximum age: 30 Years. Gender(s): Both.



- 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


- Liver (coagulopathy, transaminitis, and/or hyperbilirubinemia)

- Lungs (interstitial pneumonitis with or without pleural


- 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


- See Disease Characteristics


- See Disease Characteristics


- Not specified


- See Disease Characteristics


- Not pregnant or nursing

- Fertile patients must use effective contraception

- HIV negative


- More than 1 month since prior rituximab


- More than 4 weeks since prior chemotherapy and recovered

Endocrine therapy

- Not specified


- Not specified


- See Disease Characteristics

Locations and Contacts

Starship Children's Health, Auckland 1, New Zealand

Christchurch Hospital, Christchurch, New Zealand

Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham, Birmingham, Alabama 35294, United States

University of Alberta Hospital, Edmonton, Alberta T6G 1Z2, Canada

Phoenix Children's Hospital, Phoenix, Arizona 85016-7710, United States

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences, Little Rock, Arkansas 72205, United States

Children's & Women's Hospital of British Columbia, Vancouver, British Columbia V6H 3V4, Canada

Southern California Permanente Medical Group, Downey, California 90242-2814, United States

Loma Linda University Cancer Institute at Loma Linda University Medical Center, Loma Linda, California 92354, United States

Kaiser Permanente Medical Center - Oakland, Sacramento, California 95825, United States

UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California 94115, United States

Stanford Cancer Center, Stanford, California 94305-5824, United States

Children's Hospital Center for Cancer and Blood Disorders, Aurora, Colorado 80045, United States

Alfred I. duPont Hospital for Children, Wilmington, Delaware 19803, United States

Lee Cancer Care of Lee Memorial Health System, Fort Myers, Florida 33901, United States

University of Florida Shands Cancer Center, Gainesville, Florida 32610-0232, United States

Nemours Children's Clinic, Jacksonville, Florida 32207, United States

University of Miami Sylvester Comprehensive Cancer Center - Miami, Miami, Florida 33136, United States

Sacred Heart Cancer Center at Sacred Heart Hospital, Pensacola, Florida 32504, United States

All Children's Hospital, St. Petersburg, Florida 33701, United States

Winship Cancer Institute of Emory University, Atlanta, Georgia 30322, United States

Children's Memorial Hospital - Chicago, Chicago, Illinois 60614, United States

University of Chicago Cancer Research Center, Chicago, Illinois 60637-1470, United States

University of Illinois Cancer Center, Chicago, Illinois 60612-7243, United States

Simmons Cooper Cancer Institute, Springfield, Illinois 62794-9677, United States

Indiana University Melvin and Bren Simon Cancer Center, Indianapolis, Indiana 46202-5289, United States

Kosair Children's Hospital, Louisville, Kentucky 40232, United States

Tulane Cancer Center Office of Clinical Research, Alexandria, Louisiana 71315-3198, United States

CancerCare Manitoba, Winnipeg, Manitoba R3E 0V9, Canada

C.S. Mott Children's Hospital at University of Michigan Medical Center, Ann Arbor, Michigan 48109-0286, United States

Barbara Ann Karmanos Cancer Institute, Detroit, Michigan 48201-1379, United States

Butterworth Hospital at Spectrum Health, Grand Rapids, Michigan 49503-2560, United States

CCOP - Kalamazoo, Kalamazoo, Michigan 49007-5341, United States

Masonic Cancer Center at University of Minnesota, Minneapolis, Minnesota 55455, United States

Mayo Clinic Cancer Center, Rochester, Minnesota 55905, United States

University of Mississippi Cancer Clinic, Jackson, Mississippi 39216-4505, United States

Ellis Fischel Cancer Center at University of Missouri - Columbia, Columbia, Missouri 65203, United States

Children's Mercy Hospital, Kansas City, Missouri 64108, United States

Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis, St. Louis, Missouri 63110, United States

UNMC Eppley Cancer Center at the University of Nebraska Medical Center, Omaha, Nebraska 68198-6805, United States

Sunrise Hospital and Medical Center, Las Vegas, Nevada 89109-2306, United States

Hackensack University Medical Center Cancer Center, Hackensack, New Jersey 07601, United States

Westmead Institute for Cancer Research at Westmead Hospital, Westmead, New South Wales 2145, Australia

Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center, New York, New York 10032, United States

Mount Sinai Medical Center, New York, New York 10029, United States

James P. Wilmot Cancer Center at University of Rochester Medical Center, Rochester, New York 14642, United States

SUNY Upstate Medical University Hospital, Syracuse, New York 13210, United States

New York Medical College, Valhalla, New York 10595, United States

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill, Chapel Hill, North Carolina 27599-7295, United States

Blumenthal Cancer Center at Carolinas Medical Center, Charlotte, North Carolina 28232-2861, United States

IWK Health Centre, Halifax, Nova Scotia B3K 6R8, Canada

Akron Children's Hospital, Akron, Ohio 44308-1062, United States

Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio 45229-3039, United States

Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio 44195, United States

Rainbow Babies and Children's Hospital, Cleveland, Ohio 44106-5000, United States

Nationwide Children's Hospital, Columbus, Ohio 43205-2696, United States

Oklahoma University Cancer Institute, Oklahoma City, Oklahoma 73104, United States

Hospital for Sick Children, Toronto, Ontario M5G 1X8, Canada

Legacy Emanuel Hospital and Health Center and Children's Hospital, Portland, Oregon 97227, United States

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania 19104-9786, United States

Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania 15213, United States

Hopital Sainte Justine, Montreal, Quebec H3T 1C5, Canada

Montreal Children's Hospital at McGill University Health Center, Montreal, Quebec H3H 1P3, Canada

Royal Children's Hospital, Brisbane, Queensland 4029, Australia

East Tennessee Children's Hospital, Knoxville, Tennessee 37901, United States

Vanderbilt-Ingram Cancer Center, Nashville, Tennessee 37232-6838, United States

Driscoll Children's Hospital, Corpus Christi, Texas 78411, United States

Medical City Dallas Hospital, Dallas, Texas 75230, United States

Methodist Children's Hospital of South Texas, San Antonio, Texas 78229-3993, United States

University of Texas Health Science Center at San Antonio, San Antonio, Texas 78207, United States

Primary Children's Medical Center, Salt Lake City, Utah 84113-1100, United States

Fletcher Allen Health Care - University Health Center Campus, Burlington, Vermont 05401, United States

Inova Fairfax Hospital, Falls Church, Virginia 22042-3300, United States

Children's Hospital of The King's Daughters, Norfolk, Virginia 23507-1971, United States

Children's Hospital and Regional Medical Center - Seattle, Seattle, Washington 98105, United States

West Virginia University Health Sciences Center - Charleston, Charleston, West Virginia 25302, United States

Princess Margaret Hospital for Children, Perth, Western Australia 6001, Australia

Marshfield Clinic - Marshfield Center, Marshfield, Wisconsin 54449, United States

Additional Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: April 2004
Last updated: September 10, 2014

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017