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:
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
  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
  • 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

Active Comparator: Arm 2

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 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 April 16, 2014