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

Hodgkin's Lymphoma Clinical Trial

— HD0801  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00784537
• Other study ID #: IIL-HD0801
• Secondary ID: EudracT Number 2
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: November 3, 2008
• Last updated: February 7, 2018
• Start date: September 2008
• Est. completion date: January 2016

Study information

• Verified date: February 2018
• Source: Fondazione Italiana Linfomi ONLUS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

This study is composed by two phases:

1. A phase II multi-centre study evaluating in patients with advanced stage Hodgkin lymphoma the efficacy of an early salvage treatment with high-dose chemotherapy followed by stem cell transplantation in patients FDG-PET positive after two courses of ABVD (PET-2 positive).

2. A phase III randomised study comparing the efficacy of radiotherapy to the areas of initial bulky disease versus no further therapy in PET-2 negative patients in complete remission (PET-6 negative) at the end of six courses of ABVD.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 520
• Est. completion date: January 2016
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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%).

Related Conditions & MeSH terms

• Hodgkin Disease
• Hodgkin's Lymphoma
• Lymphoma

Intervention

Drug:
• ABVD
ABVD courses are scheduled every 28 days: 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 ABVD courses are scheduled every 28 days: 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 Randomization to Arm A (Observation)
• ABVD and Radiotherapy
ABVD courses are scheduled every 28 days: 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 Randomization to Arm B, Radiotherapy, in patients in CR, on the area of initial bulky disease (see above for the definition of nodal and/or mediastinal bulk).

Locations

Country	Name	City	State
Italy	Centro di riferimento Oncologico Oncologia Medica A	Aviano
Italy	Università Policlinico di Bari - Divisione di Medicina A	Bari
Italy	Policlinco Sant'Orsola Isituto di Ematologia ed oncologia Medica	Bologna
Italy	Sezione di Ematologia Spedali Civili	Brescia
Italy	Ospedale di Circolo SC Oncologia Medica III	Busto Arsizio
Italy	Divisione di Ematologia Osp.Businco	Cagliari
Italy	Policlinico Careggi Cattedra di Ematologia	Firenze
Italy	ASLTO4	Ivrea
Italy	Osp. Cardinale Panico Divisione di Ematologia Tricase	Lecce
Italy	Ospedale Niguarda Cà Granda	Milano
Italy	Università Avogadro Divisione di Ematologia	Novara
Italy	Ospedale San Francesco UO Ematologia e Centro Trapianti	Nuoro
Italy	Fondazione Policlinico San Matteo Clinica Ematologica	Pavia
Italy	Osp. Santa Maria delle Croci UO Ematologia	Ravenna
Italy	Ospedale Bianchi Melacrino Morelli	Reggio Calabria
Italy	Osp. degli Infermi Divisione di Oncologia	Rimini
Italy	Istituto Regina Elena IFO SC Ematologia	Roma
Italy	Osp.Sant'Eugenio Divisione di Ematologia	Roma
Italy	Università La Sapienza Dipartimento di Biotecnnologie Cellulari	Roma
Italy	Istituto Clinico Humanitas Divisione di Oncologia Medica ed Ematologia	Rozzano (MI)
Italy	AO Universitaria di Sassari	Sassari
Italy	Policlinico Le Scotte	Siena
Italy	Struttura Complessa di Onco-Ematologia	Terni
Italy	IRCC Onco-Ematologia Candiolo	Torino
Italy	Osp. San Giovanni Battista_Molinette Ematologia 2	Torino
Italy	Azienda Ospedaliero universitaria di Udine	Udine
Italy	ASL 14 UO Oncologia	Verbania

Sponsors (2)

Lead Sponsor	Collaborator
Fondazione Italiana Linfomi ONLUS	Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		4 years
Secondary	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.		4 years