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 |
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Recruitment Status :
Completed
First Posted : November 4, 2008
Last Update Posted : February 8, 2018
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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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Hodgkin's Lymphoma | Drug: ABVD Drug: ABVD and Radiotherapy | Phase 2 Phase 3 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 520 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (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 |
| Study Start Date : | September 2008 |
| Actual Primary Completion Date : | January 2015 |
| Actual Study Completion Date : | January 2016 |
| Arm | Intervention/treatment |
|---|---|
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Arm A
Two courses of ABVD. Early restaging with FDG-PET scan (PET-2) The subsequent treatment will be as it follows:
The following restaging procedures are planned as it follows:
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) |
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Arm B
Two courses of ABVD. Early restaging with FDG-PET scan (PET-2) The subsequent treatment will be as it follows:
The following restaging procedures are planned as it follows:
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). |
- 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 ]
- 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 ]
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| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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%).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00784537
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| Study Director: | Alessandro Levis, MD | Ospedale SS. Antonio, Biagio e Cesare Arrigo |
| Responsible Party: | Fondazione Italiana Linfomi ONLUS |
| ClinicalTrials.gov Identifier: | NCT00784537 |
| Other Study ID Numbers: |
IIL-HD0801 EudracT Number 2008−002684−14 |
| First Posted: | November 4, 2008 Key Record Dates |
| Last Update Posted: | February 8, 2018 |
| Last Verified: | February 2018 |
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Hodgkin's lymphoma ABVD FDG-PET (18-Fluoro-deoxy-D-glucose Positron Emission Tomography) Radiotherapy |
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Lymphoma Hodgkin Disease Neoplasms by Histologic Type Neoplasms |
Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |