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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)


Phase 2
N/A
30 Years
Not Enrolling
Both
Lymphoproliferative Disorder

Thank you

Trial Information

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)


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.

Inclusion 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

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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Event-free survival at 2 years

Outcome Description:

Estimated by Kaplan-Meier method. The correlation between outcome (EFS or OS) and covariates such as EBV viral load, EBV-CTL, subsets of PBL, dendritic cells in peripheral blood, and peripheral blood levels of Rituximab will be evaluated using the proportional hazards model. The correlation between gene expression and survival will also be evaluated using the proportional hazards model

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Thomas G. Gross, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Nationwide Children's Hospital

Authority:

United States: Federal Government

Study ID:

ANHL0221

NCT ID:

NCT00066469

Start Date:

April 2004

Completion Date:

Related Keywords:

  • Lymphoproliferative Disorder
  • post-transplant lymphoproliferative disorder
  • Lymphoproliferative Disorders

Name

Location

Children's Hospital of PhiladelphiaPhiladelphia, Pennsylvania  19104
Mayo Clinic Cancer CenterRochester, Minnesota  55905
University of Chicago Cancer Research CenterChicago, Illinois  60637
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
Medical City Dallas HospitalDallas, Texas  75230
University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811
CCOP - KalamazooKalamazoo, Michigan  49007-3731
Vanderbilt-Ingram Cancer CenterNashville, Tennessee  37232-6838
Marshfield Clinic - Marshfield CenterMarshfield, Wisconsin  54449
New York Medical CollegeValhalla, New York  10595
Ellis Fischel Cancer Center at University of Missouri - ColumbiaColumbia, Missouri  65203
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillChapel Hill, North Carolina  27599-7570
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
Children's Mercy HospitalKansas City, Missouri  64108
Children's Hospital of PittsburghPittsburgh, Pennsylvania  15213
Children's Hospital and Regional Medical Center - SeattleSeattle, Washington  98105
Nemours Children's ClinicJacksonville, Florida  32207
All Children's HospitalSt. Petersburg, Florida  33701
Children's Memorial Hospital - ChicagoChicago, Illinois  60614
Driscoll Children's HospitalCorpus Christi, Texas  78466
Inova Fairfax HospitalFalls Church, Virginia  22042-3300
Fletcher Allen Health Care - University Health Center CampusBurlington, Vermont  05401
Phoenix Children's HospitalPhoenix, Arizona  85016-7710
Southern California Permanente Medical GroupDowney, California  90242
Kosair Children's HospitalLouisville, Kentucky  40202-3830
Sunrise Hospital and Medical CenterLas Vegas, Nevada  89109-2306
East Tennessee Children's HospitalKnoxville, Tennessee  37901
Children's Hospital of the King's DaughtersNorfolk, Virginia  23507
Arkansas Cancer Research Center at University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Blumenthal Cancer Center at Carolinas Medical CenterCharlotte, North Carolina  28232-2861
Loma Linda University Cancer Institute at Loma Linda University Medical CenterLoma Linda, California  92354
Kaiser Permanente Medical Center - OaklandSacramento, California  95825
Lee Cancer Care of Lee Memorial Health SystemFort Myers, Florida  33901
University of Florida Shands Cancer CenterGainesville, Florida  32610-0232
Sacred Heart Cancer Center at Sacred Heart HospitalPensacola, Florida  32504
Winship Cancer Institute of Emory UniversityAtlanta, Georgia  30322
Hackensack University Medical Center Cancer CenterHackensack, New Jersey  07601
Mount Sinai Medical CenterNew York, New York  10029
SUNY Upstate Medical University HospitalSyracuse, New York  13210
Cincinnati Children's Hospital Medical CenterCincinnati, Ohio  45229-3039
Rainbow Babies and Children's HospitalCleveland, Ohio  44106-5000
Methodist Children's Hospital of South TexasSan Antonio, Texas  78229-3993
Primary Children's Medical CenterSalt Lake City, Utah  84113-1100
James P. Wilmot Cancer Center at University of Rochester Medical CenterRochester, New York  14642
UNMC Eppley Cancer Center at the University of Nebraska Medical CenterOmaha, Nebraska  68198-7680
UCSF Helen Diller Family Comprehensive Cancer CenterSan Francisco, California  94115
Children's Hospital Center for Cancer and Blood DisordersAurora, Colorado  80045
Alfred I. duPont Hospital for ChildrenWilmington, Delaware  19803
University of Illinois Cancer CenterChicago, Illinois  60612-7243
Simmons Cooper Cancer InstituteSpringfield, Illinois  62794-9677
Indiana University Melvin and Bren Simon Cancer CenterIndianapolis, Indiana  46202-5289
Tulane Cancer Center Office of Clinical ResearchAlexandria, Louisiana  71315-3198
C.S. Mott Children's Hospital at University of Michigan Medical CenterAnn Arbor, Michigan  48109-0286
Butterworth Hospital at Spectrum HealthGrand Rapids, Michigan  49503-2560
Masonic Cancer Center at University of MinnesotaMinneapolis, Minnesota  55455
University of Mississippi Cancer ClinicJackson, Mississippi  39216-4505
Siteman Cancer Center at Barnes-Jewish Hospital - Saint LouisSt. Louis, Missouri  63110
Herbert Irving Comprehensive Cancer Center at Columbia University Medical CenterNew York, New York  10032
Akron Children's HospitalAkron, Ohio  44308-1062
Nationwide Children's HospitalColumbus, Ohio  43205-2696
Oklahoma University Cancer InstituteOklahoma City, Oklahoma  73104
Legacy Emanuel Hospital and Health Center and Children's HospitalPortland, Oregon  97227
West Virginia University Health Sciences Center - CharlestonCharleston, West Virginia  25302
Stanford Cancer CenterStanford, California  94305-5824
University of Miami Sylvester Comprehensive Cancer Center - MiamiMiami, Florida  33136
Lurleen Wallace Comprehensive Cancer at University of Alabama - BirminghamBirmingham, Alabama  35294