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MULTICENTER RANDOMIZED PROGRAM COMPARING HIGH-DOSE CHEMOTHERAPY + RITUXIMAB AND PERIPHERAL BLOOD PROGENITOR CELL (PBPC) AUTOGRAFT vs. CHOP + RITUXIMAB AS FIRST-LINE TREATMENT FOR PATIENTS WITH HIGH-RISK FOLLICULAR LYMPHOMA


Phase 3
18 Years
60 Years
Open (Enrolling)
Both
Follicular Lymphoma

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Trial Information

MULTICENTER RANDOMIZED PROGRAM COMPARING HIGH-DOSE CHEMOTHERAPY + RITUXIMAB AND PERIPHERAL BLOOD PROGENITOR CELL (PBPC) AUTOGRAFT vs. CHOP + RITUXIMAB AS FIRST-LINE TREATMENT FOR PATIENTS WITH HIGH-RISK FOLLICULAR LYMPHOMA


The place of intensified regimens with autologous stem cell transplantation (ASCT) is poorly
defined in FL at diagnosis . Most data arise from studies performed in the pre-Rituximab
age. According to these studies, ASCT improved overall survival versus standard salvage
approaches in relapsed patients with a high proportion of patients achieving a durable
molecular remission. Data at diagnosis are less clear. Three studies have been so far
published with contradictory results. Two of these studies showed that intensive therapy
ensures a better disease control although in one study a significant extra-mortality from
secondary tumors was observed in the intensified arm. A third study found no advantage for
patients treated intensively. These results led to the widespread notion that ASCT is not
superior to conventional chemotherapy in unselected FL patients. Our previous non-randomized
experience employing high dose sequential chemotherapy with a final TBI-free ASCT added some
clues to these considerations. Our study employs an autografting procedure which is
associated to fewer secondary tumors as it does not include total body irradiation. Moreover
we have observed that the our regimen (named HDS) is particularly effective in high-risk
patients, suggesting that this specific subgroup is the most appropriate setting for
intensified regimens

The present multicenter open label randomized trial took advantage of these observations. In
addition we have included Rituximab in both arms as the inclusion of this novel agent is
expected to significantly modify the performance of available treatments. We have thus
compared a Rituximab-supplemented version of HDS (R-HDS) regimen with six CHOP courses
supplemented by an identical number of Rituximab courses. Aim of the study was verify if an
intensified approach could be beneficial as first line treatment of high-risk FL patients in
the Rituximab age.


Inclusion Criteria:



1. Follicular Lymphoma at diagnosis

2. Stage >I

3. age-adjusted I.P.I. score 2 or 3 or three or more adverse factors of the I.L.I. score

Exclusion Criteria:

1. Serum positivity for HIV, HCV. HBsAg-positive only if active viral replication,
assessed by HBV-DNA was present.

2. Major alterations of heart, lung, kidneys, liver, except for those directly
disease-related;

3. Evidence of second tumors;

4. Previous chemotherapy( except patients who received limited radiotherapy);

5. Cerebral or CNS involvement.

6. Drug addiction or severe psychiatric disease

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Event free survival at three years

Principal Investigator

Corrado Tarella, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Università di Torino, Azienda Ospedaliera San Giovanni Battista

Authority:

Italy: Ministry of Health

Study ID:

3320

NCT ID:

NCT00435955

Start Date:

March 2000

Completion Date:

Related Keywords:

  • Follicular Lymphoma
  • Follicular lymphoma
  • age adjusted IPI >1
  • IIL score > 2
  • Molecular remission
  • High dose chemotherapy and autologous transplantation
  • Rituximab
  • Lymphoma
  • Lymphoma, Follicular

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