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NCT Number: NCT00784537

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

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.

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Key information

Conditions

Hodgkin's Lymphoma Hemic and Lymphatic Diseases Hodgkin Disease Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Centro di riferimento Oncologico Oncologia Medica A, Aviano, Italy

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About this study

This study is composed by two phases:

  • 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).
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%).

Treatment and study plan

ABVD

Drug

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

Drug

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).

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Fondazione Italiana Linfomi - ETS

Other

Collaborators

  • Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte

Registry information

Official study 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

Acronym: HD0801

Important dates

Study start
2008
Primary completion
2015
Study completion
2016
First posted
Nov 4, 2008
Registry last updated
Feb 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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