High-dose Chemotherapy and Stem Cell Transplantation, in Patients PET-2 Positive, After 2 Courses of ABVD and Comparison of RT Versus no RT in PET-2 Negative Patients (HD0801)
This study is currently recruiting participants.
Verified December 2008 by Fondazione Italiana Linfomi ONLUS
Sponsor:
Fondazione Italiana Linfomi ONLUS
Collaborator:
Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte
Information provided by:
Fondazione Italiana Linfomi ONLUS
ClinicalTrials.gov Identifier:
NCT00784537
First received: November 3, 2008
Last updated: June 23, 2011
Last verified: December 2008
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Purpose
The purpose of this study is to define an improvement in patients:
- To evaluate if patients resistant to the initial treatment for residual PET-positive masses after the first two courses of ABVD (PET-2 positive), can be salvaged by early shift to high-dose chemotherapy supported by stem cell rescue
- To analyse if patients achieving early complete response (PET-2 negative), can be spared the adjuvant radiotherapy on areas of initial bulky disease, at the end of the planned six courses of ABVD. To answer this question, PET-2 negative patients will be randomized between radiotherapy versus no radiotherapy at the end of ABVD therapy.
| Condition | Intervention | Phase |
|---|---|---|
|
Hodgkin's Lymphoma |
Drug: ABVD |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Early Salvage With High Dose Chemotherapy and Stem Cell Transplantation in Advanced Stage Hodgkin's Lymphoma Patients With Positive PET After Two Courses of ABVD (PET-2 Positive) and Comparison of RT Versus no RT in PET-2 Negative Patients |
Resource links provided by NLM:
Further study details as provided by Fondazione Italiana Linfomi ONLUS:
Primary Outcome Measures:
- To evaluate if patients resistant to the initial treatment for residual PET-positive masses after the first two courses of ABVD (PET-2 positive), can be salvaged by early shift to high-dose chemotherapy supported by stem cell rescue. [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- To analyse if patients achieving early complete response (PET-2 negative), can be spared the adjuvant radiotherapy on areas of initial bulky disease, at the end of the planned six courses of ABVD. [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 300 |
| Study Start Date: | September 2008 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
Active Comparator: Arm 1
PET-6 negative patients will be randomized to first arm: No radiotherapy. |
Drug: ABVD
ABVD courses are scheduled every 28 days (see Appendix F): Doxorubicin 25 mg/m2 i.v. day 1 and 15 Bleomycin 10 mg/m2 i.v. day 1 and 15 Vinblastine 6 mg/m2 i.v. day 1 and 15 Dacarbazine 375 mg/m2 i.v. day 1 and 15 |
|
Active Comparator: Arm 2
Two courses of ABVD. Early restaging with FDG-PET scan (PET-2) The subsequent treatment will be as it follows:
The following restaging procedures are planned as it follows:
PET-6 negative patients will be randomized to first arm: Adjuvant radiotherapy (30 Gy) on sites of initial bulky disease. |
Drug: ABVD
ABVD courses are scheduled every 28 days (see Appendix F): Doxorubicin 25 mg/m2 i.v. day 1 and 15 Bleomycin 10 mg/m2 i.v. day 1 and 15 Vinblastine 6 mg/m2 i.v. day 1 and 15 Dacarbazine 375 mg/m2 i.v. day 1 and 15 |
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Histologically confirmed Hodgkin's lymphoma of the classical type (nodular lymphocyte predominance excluded).
- Stage IIB-IV.
- Age 18-70.
- No prior therapy for Hodgkin's lymphoma
- Written informed consent.
- ECOG performance status grades 0-3 (see Appendix E).
- FDG-PET scan before the initiation of treatment.
Exclusion Criteria:
- Prior therapy for Hodgkin's lymphoma.
- Age less than 18 or more than 70.
- Other concomitant or prior malignancies, except basal cell skin carcinoma, or adequately treated carcinoma in situ of the cervix, or any cancer in complete remission for more than 5 years.
- HIV infection.
- Pregnancy or breast-feeding.
- Renal failure (creatinine ≥2 times the normal value), liver failure (AST/ALT or bilirubine ≥ 2.5 times the normal value) or heart failure (NYHA class ≥ 2 or FEV < 45%).
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00784537
Show 60 Study Locations
Contacts
| Contact: Daniela Gioia, PhD | 0131/206129 | dgioia@ospedale.al.it |
| Contact: Antonella Ferranti, PhD | 0131/206129 | aferranti@ospedale.al.it |
Show 60 Study LocationsSponsors and Collaborators
Fondazione Italiana Linfomi ONLUS
Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte
Investigators
| Study Director: | Alessandro Levis, MD | Ospedale SS. Antonio, Biagio e Cesare Arrigo |
More Information
No publications provided
| Responsible Party: | Alessandro Levis, A.O. SS. Antonio e Biagio e C. Arrigo |
| ClinicalTrials.gov Identifier: | NCT00784537 History of Changes |
| Other Study ID Numbers: | IIL-HD0801, EudracT Number 2008−002684−14 |
| Study First Received: | November 3, 2008 |
| Last Updated: | June 23, 2011 |
| Health Authority: | Italy: National Monitoring Centre for Clinical Trials - Ministry of Health |
Keywords provided by Fondazione Italiana Linfomi ONLUS:
|
Hodgkin's lymphoma ABVD |
Additional relevant MeSH terms:
|
Hodgkin Disease Lymphoma Neoplasms by Histologic Type Neoplasms |
Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013