Sequential Treatment of CD20-positive Posttransplant Lymphoproliferative Disorder (PTLD)

NCT01458548 | Terminated Phase 2

• 1 other identifier: PTLD-1
• Study Type: interventional
• Target: 70
• Locations: 4 countries
• Sites: 4

Brief Summary

Post-transplantation lymphoproliferative disorder (PTLD) develops in one to ten per cent of transplant recipients and can be EBV-associated. To improve long-term efficacy after rituximab monotherapy and to avoid the toxicity of CHOP seen in first-line treatment, the investigators initiated an international multicentre phase II trial to test whether the subsequent application of rituximab and four courses of three-weekly CHOP would improve the outcome of patients with PTLD: PTLD-1, sequential treatment (ST).

Conditions

Post-transplantation Lymphoproliferative Disorder

Keywords

1st-line therapy; single agent rituximab; CHOP; PTLD

Outcome Measures

Primary Outcomes (2)

• number of patients with complete and partial remission

  1 month (plus or minus 7 days) after the last cycle of chemotherapy

• response duration

  from date of best response until the date of first documented progression, assessed up to 3 years

Secondary Outcomes (2)

• number of patients with treatment-related death

  from start of treatment, assessed up to 12 months after the end of treatment

• overall survival

  from start of treatment until date of death from any cause, assessed up to 3 years

Interventions

Rituximab DRUG

Rituximab 375 mg/m2 IV on days 1, 8, 15 and 22.

CHOP DRUG

Cyclophosphamide 750 mg/m2 IV, adriamycine 50 mg/m2 IV, vincristine 1.4mg/m2 IV, and prednisone 50mg/m2 PO every 3 weeks at days 50, 72, 94 and 116.

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• PTLD with or without EBV association, confirmed after biopsy or resection
• Measurable disease of \> 2 cm in diameter and/or bone marrow involvement
• Patients having undergone heart, lung, liver, kidney, pancreas, small intestine transplantation or other or a combination of the organ transplantations mentioned
• Karnofsky scale \>50% or ECOG ≤ 3
• Reduction of immunosuppression with or without antiviral therapy
• A complete surgical extirpation of tumor was not performed
• A radiation therapy was not performed
• Effective contraception for women in childbearing age
• Patient's written informed consent and written consent for data collection
• Patients are \> 18 years (or ≥ 15 years with parental agreement )

You may not qualify if:

• Life expectancy less than 6 weeks
• Karnofsky-scale \<50% or ECOG =3
• Treatment with rituximab before
• Known allergic reactions against foreign proteins
• Concomitant diseases, which exclude the administration of therapy as outlined by the study protocol
• non-compensated heart failure
• Dilatative cardiomyopathy
• Myocardial infarction during the last 6 months
• Severe non-compensated hypertension
• Severe non-compensated diabetes mellitus
• Renal insufficiency (creatinine more than 3-fold of the upper normal value), not related to lymphoma.
• Hepatic insufficiency with transaminase values greater than 3-fold of the normal values and/or bilirubin levels \>3.0 mg/dl, not related to lymphoma
• Clinical signs of cerebral dysfunction
• Women during the lactation period, pregnant or of childbearing potential not using a reliable contraceptive method
• Involvement of the central nervous system by the disease

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (4)

Princess Alexandra Hospital, Ipswich Rd, Woolloongabba, Qld 4102

Brisbane, Australia

Location

Hôpital Pitié-Salpétrière, Department of Hematology, 47-83 Boulevard de l'Hopital

Paris, 75651, France

Location

Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum, Department of Hematology and Oncology, Augustenburger Platz 1

Berlin, 13353, Germany

Location

Sahlgrens hospital, Department of Hematology

Gothenburg, 41345, Sweden

Location

Related Publications (2)

• Trappe RU, Dierickx D, Zimmermann H, Morschhauser F, Mollee P, Zaucha JM, Dreyling MH, Duhrsen U, Reinke P, Verhoef G, Subklewe M, Huttmann A, Tousseyn T, Salles G, Kliem V, Hauser IA, Tarella C, Van Den Neste E, Gheysens O, Anagnostopoulos I, Leblond V, Riess H, Choquet S. Response to Rituximab Induction Is a Predictive Marker in B-Cell Post-Transplant Lymphoproliferative Disorder and Allows Successful Stratification Into Rituximab or R-CHOP Consolidation in an International, Prospective, Multicenter Phase II Trial. J Clin Oncol. 2017 Feb 10;35(5):536-543. doi: 10.1200/JCO.2016.69.3564. Epub 2016 Dec 19.

  PMID: 27992268 DERIVED

• Trappe R, Oertel S, Leblond V, Mollee P, Sender M, Reinke P, Neuhaus R, Lehmkuhl H, Horst HA, Salles G, Morschhauser F, Jaccard A, Lamy T, Leithauser M, Zimmermann H, Anagnostopoulos I, Raphael M, Riess H, Choquet S; German PTLD Study Group; European PTLD Network. Sequential treatment with rituximab followed by CHOP chemotherapy in adult B-cell post-transplant lymphoproliferative disorder (PTLD): the prospective international multicentre phase 2 PTLD-1 trial. Lancet Oncol. 2012 Feb;13(2):196-206. doi: 10.1016/S1470-2045(11)70300-X. Epub 2011 Dec 13.

  PMID: 22173060 DERIVED

Related Links

• Trial Protocol

MeSH Terms

Interventions

Rituximab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Ralf U Trappe, MD

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head German PTLD Study Group

Study Record Dates

• First Submitted: October 18, 2011
• First Posted: October 25, 2011
• Study Start: December 1, 2002
• Primary Completion: May 1, 2008
• Study Completion: October 1, 2011
• Last Updated: October 25, 2011

Record last verified: 2011-10

Locations

DE (1); AU (1); FR (1); SE (1)