Sequential Treatment of CD20-positive Posttransplant Lymphoproliferative Disorder (PTLD)
This study has been terminated.
(This study had an major amendment in 12/2006 introducing risk stratified sequential treatment (RSST). The modified protocol is registered with NCT00590447.)
Sponsor:
Charite University, Berlin, Germany
Information provided by (Responsible Party):
Ralf Trappe, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01458548
First received: October 18, 2011
Last updated: October 24, 2011
Last verified: October 2011
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Post-transplantation Lymphoproliferative Disorder |
Drug: Rituximab Drug: CHOP |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Treatment of Patients With Posttransplant Lymphoproliferative Disorder (PTLD) With a Sequential Treatment Consisting of Anti-CD20 Antibody Rituximab and CHOP+GCSF Chemotherapy (Including 1st+2nd Amendment) |
Resource links provided by NLM:
Further study details as provided by Charite University, Berlin, Germany:
Primary Outcome Measures:
- number of patients with complete and partial remission [ Time Frame: 1 month (plus or minus 7 days) after the last cycle of chemotherapy ] [ Designated as safety issue: No ]
- response duration [ Time Frame: from date of best response until the date of first documented progression, assessed up to 3 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- number of patients with treatment-related death [ Time Frame: from start of treatment, assessed up to 12 months after the end of treatment ] [ Designated as safety issue: Yes ]
- overall survival [ Time Frame: from start of treatment until date of death from any cause, assessed up to 3 years ] [ Designated as safety issue: Yes ]
| Enrollment: | 70 |
| Study Start Date: | December 2002 |
| Study Completion Date: | October 2011 |
| Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Drug: Rituximab
Rituximab 375 mg/m2 IV on days 1, 8, 15 and 22.
Drug: CHOP
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| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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 )
Exclusion Criteria:
- 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
- Severe psychiatric disease
- Known to be HIV positive
- Missing written informed consent of the patient
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01458548
Locations
| Australia | |
| Princess Alexandra Hospital, Ipswich Rd, Woolloongabba, Qld 4102 | |
| Brisbane, Australia | |
| France | |
| Hôpital Pitié-Salpétrière, Department of Hematology, 47-83 Boulevard de l'Hopital | |
| Paris, France, 75651 | |
| Germany | |
| Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum, Department of Hematology and Oncology, Augustenburger Platz 1 | |
| Berlin, Germany, 13353 | |
| Sweden | |
| Sahlgrens hospital, Department of Hematology | |
| Göteborg, Sweden, 41345 | |
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
| Principal Investigator: | Ralf U Trappe, MD | Charite University, Berlin, Germany |
More Information
Additional Information:
No publications provided by Charite University, Berlin, Germany
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Ralf Trappe, Head German PTLD Study Group, Charite University, Berlin, Germany |
| ClinicalTrials.gov Identifier: | NCT01458548 History of Changes |
| Other Study ID Numbers: | PTLD-1 |
| Study First Received: | October 18, 2011 |
| Last Updated: | October 24, 2011 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by Charite University, Berlin, Germany:
|
1st-line therapy single agent rituximab CHOP PTLD |
Additional relevant MeSH terms:
|
Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Rituximab Immunologic Factors |
Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents |
ClinicalTrials.gov processed this record on June 18, 2013