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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


Phase 3
18 Years
70 Years
Open (Enrolling)
Both
Hodgkin's Lymphoma

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Trial Information

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


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%).

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

4 years

Safety Issue:

Yes

Principal Investigator

Alessandro Levis, MD

Investigator Role:

Study Director

Investigator Affiliation:

Ospedale SS. Antonio, Biagio e Cesare Arrigo

Authority:

Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Study ID:

IIL-HD0801

NCT ID:

NCT00784537

Start Date:

September 2008

Completion Date:

December 2014

Related Keywords:

  • Hodgkin's Lymphoma
  • Hodgkin's lymphoma
  • ABVD
  • Hodgkin Disease
  • Lymphoma

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