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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)

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ClinicalTrials.gov Identifier: NCT00784537
Recruitment Status : Completed
First Posted : November 4, 2008
Last Update Posted : February 8, 2018
Sponsor:
Collaborator:
Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte
Information provided by (Responsible Party):
Fondazione Italiana Linfomi ONLUS

Tracking Information
First Submitted Date  ICMJE November 3, 2008
First Posted Date  ICMJE November 4, 2008
Last Update Posted Date February 8, 2018
Study Start Date  ICMJE September 2008
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 3, 2008)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 3, 2008)
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
Brief Summary

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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hodgkin's Lymphoma
Intervention  ICMJE
  • 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)

  • 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).

Study Arms  ICMJE
  • 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.

    Intervention: Drug: ABVD
  • 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.

    Intervention: Drug: ABVD and Radiotherapy
Publications * Zinzani PL, Broccoli A, Gioia DM, Castagnoli A, Ciccone G, Evangelista A, Santoro A, Ricardi U, Bonfichi M, Brusamolino E, Rossi G, Anastasia A, Zaja F, Vitolo U, Pavone V, Pulsoni A, Rigacci L, Gaidano G, Stelitano C, Salvi F, Rusconi C, Tani M, Freilone R, Pregno P, Borsatti E, Sacchetti GM, Argnani L, Levis A. Interim Positron Emission Tomography Response-Adapted Therapy in Advanced-Stage Hodgkin Lymphoma: Final Results of the Phase II Part of the HD0801 Study. J Clin Oncol. 2016 Apr 20;34(12):1376-85. doi: 10.1200/JCO.2015.63.0699. Epub 2016 Feb 16.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 11, 2015)
520
Original Estimated Enrollment  ICMJE
 (submitted: November 3, 2008)
300
Actual Study Completion Date  ICMJE January 2016
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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%).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00784537
Other Study ID Numbers  ICMJE IIL-HD0801
EudracT Number 2008−002684−14
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Fondazione Italiana Linfomi ONLUS
Study Sponsor  ICMJE Fondazione Italiana Linfomi ONLUS
Collaborators  ICMJE Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte
Investigators  ICMJE
Study Director: Alessandro Levis, MD Ospedale SS. Antonio, Biagio e Cesare Arrigo
PRS Account Fondazione Italiana Linfomi ONLUS
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP