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 ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte
Information provided by (Responsible Party):
Fondazione Italiana Linfomi ONLUS
ClinicalTrials.gov Identifier:
NCT00784537
First received: November 3, 2008
Last updated: February 12, 2015
Last verified: February 2015
  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
Drug: ABVD and Radiotherapy
Phase 2
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 ]

Enrollment: 520
Study Start Date: September 2008
Estimated Study Completion Date: January 2016
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm A

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:

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)

Arm B

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 second arm:

Adjuvant radiotherapy (30 Gy) on sites of initial bulky disease.

Drug: 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).


Detailed 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.
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00784537

  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: Fondazione Italiana Linfomi ONLUS
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: February 12, 2015
Health Authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Keywords provided by Fondazione Italiana Linfomi ONLUS:
Hodgkin's lymphoma
ABVD
FDG-PET (18-Fluoro-deoxy-D-glucose Positron Emission Tomography)
Radiotherapy

Additional relevant MeSH terms:
Hodgkin Disease
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoma
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on July 29, 2015