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)

Fondazione Italiana Linfomi - ETS

Status and phase: Completed; Phase 3; Phase 2

Conditions: Hodgkin's Lymphoma

Treatments: Drug: ABVD; Drug: ABVD and Radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00784537

EudracT Number 2008-002684-14

IIL-HD0801

Details and patient eligibility

About

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.

Full 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.

Enrollment: 520 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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%).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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520 participants in 2 patient groups

Arm A

Other group

Description:

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.

Treatment:

Drug: ABVD

Arm B

Other group

Description:

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.

Treatment:

Drug: ABVD and Radiotherapy