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 - Full Text View

Sponsors and Collaborators:	Fondazione Intergruppo Italiano Linfomi Onlus Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica (CPO) Piemonte
Information provided by:	Fondazione Intergruppo Italiano Linfomi Onlus
ClinicalTrials.gov Identifier:	NCT00784537

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 III

MedlinePlus related topics: Hodgkin's Disease Lymphoma

Drug Information available for: Doxorubicin Doxorubicin hydrochloride Dacarbazine Vinblastine Vinblastine sulfate Bleomycin Bleomycin sulfate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Fondazione Intergruppo Italiano 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
Arm 1: Active Comparator Two courses of ABVD. Early restaging with FDG-PET scan (PET-2) The subsequent treatment will be as it follows: PET-2 positive patients will be high-dose salvage treatment; PET-2 negative patients will be treated with four additional courses of ABVD (for a total of six courses). The following restaging procedures are planned as it follows: Optional: Whole body CT scan after the fourth course of ABVD; no therapy change will be made according to CT scan. Mandatory: Whole body CT and FDG-PET scans after the sixth course of ABVD (PET-6). 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
Arm 2: Active Comparator Two courses of ABVD. Early restaging with FDG-PET scan (PET-2) The subsequent treatment will be as it follows: PET-2 positive patients will be high-dose salvage treatment; PET-2 negative patients will be treated with four additional courses of ABVD (for a total of six courses). The following restaging procedures are planned as it follows: Optional: Whole body CT scan after the fourth course of ABVD; no therapy change will be made according to CT scan. Mandatory: Whole body CT and FDG-PET scans after the sixth course of ABVD (PET-6). 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

Arms

Assigned Interventions

Arm 1: Active Comparator

Two courses of ABVD.
Early restaging with FDG-PET scan (PET-2)
The subsequent treatment will be as it follows:
1. PET-2 positive patients will be high-dose salvage treatment;
2. PET-2 negative patients will be treated with four additional courses of ABVD (for a total of six courses).
The following restaging procedures are planned as it follows:
- Optional: Whole body CT scan after the fourth course of ABVD; no therapy change will be made according to CT scan.
- Mandatory: Whole body CT and FDG-PET scans after the sixth course of ABVD (PET-6).

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

Arm 2: Active Comparator

Two courses of ABVD. Early restaging with FDG-PET scan (PET-2)

The subsequent treatment will be as it follows:

PET-2 positive patients will be high-dose salvage treatment;
PET-2 negative patients will be treated with four additional courses of ABVD (for a total of six courses).

The following restaging procedures are planned as it follows:

Optional: Whole body CT scan after the fourth course of ABVD; no therapy change will be made according to CT scan.
Mandatory: Whole body CT and FDG-PET scans after the sixth course of ABVD (PET-6).

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

Contacts

Contact: Daniela Gioia, PhD	0131/206129	dgioia@ospedale.al.it
Contact: Antonella Ferranti, PhD	0131/206129	aferranti@ospedale.al.it

Show 60 Study Locations

Sponsors and Collaborators

Fondazione Intergruppo Italiano Linfomi Onlus

Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica (CPO) Piemonte

Investigators

Study Director:

Alessandro Levis, MD

Ospedale SS. Antonio, Biagio e Cesare Arrigo

More Information

Responsible Party:	A.O. SS. Antonio e Biagio e Cesare Arrigo ( Alessandro Levis )
Study ID Numbers:	IIL-HD0801, EudracT Number 2008−002684−14
Study First Received:	November 3, 2008
Last Updated:	December 18, 2008
ClinicalTrials.gov Identifier:	NCT00784537
Health Authority:	Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Keywords provided by Fondazione Intergruppo Italiano Linfomi Onlus:

Hodgkin's lymphoma
ABVD

Study placed in the following topic categories:

Lymphatic Diseases
Dacarbazine
Hodgkin's disease
Immunoproliferative Disorders
Hodgkin lymphoma, adult
Vinblastine

Lymphoproliferative Disorders
Bleomycin
Hodgkin Disease
Lymphoma
Doxorubicin

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Immune System Diseases

ClinicalTrials.gov processed this record on January 16, 2009