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Sponsored by: |
Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS |
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Information provided by: | Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS |
ClinicalTrials.gov Identifier: | NCT00696735 |
Follicular lymphomas are a subgroup of B-cell non-Hodgkin lymphomas, accounting for 15% to 30% of newly diagnosed lymphomas.1-3 Median survival varies from 5 to 10 years depending on the prognostic factors at diagnosis and response to first-line therapy.4-6 Whatever the treatment, no plateau appears on survival curves, and virtually all patients relapse; follicular lymphomas are ultimately progressive, and fatal.2,3,5 No reference first-line treatment is clearly defined. One of the most active therapies is still doxorubicin-based chemotherapy with or without interferon.7-9 New therapeutic approaches including purine analogs and anti-CD20 monoclonal antibody are promising and are progressively included in the management of these lymphomas.2,3,10-13 The role of high-dose therapy (HDT) as a salvage treatment for patients with relapsing follicular lymphoma is demonstrated by some authors; several reports have shown the superiority of HDT followed by autologous stem-cell transplantation, purged or unpurged, compared with conventional chemotherapy in terms of no relapse and overall survival.14-18 Only a few reports have been published showing HDT results as a first-line treatment for poor-risk patients with follicular lymphoma, and the results remain controversial.19-26 These data prompted the French Groupe Ouest-Est des Leucémies et Autres Maladies du Sang (GOELAMS) to conduct a prospective randomized trial using patients with newly diagnosed follicular lymphoma with a high tumor burden. A combined doxorubicin-based chemotherapy associated with interferon was compared to front-line HDT followed by purged autologous stem-cell transplantation.
Condition | Intervention | Phase |
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Follicular Lymphoma |
Procedure: chemotherapy Procedure: high dose therapy and autologous stem cell transplantation |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Randomized Phase III Study Comparison Between Conventional Chemotherapy and High-Dose Therapy Followed by Autologous Purged Stem-Cell Transplantation in Patients With Follicular Lymphoma Stage III,IV First-Line Treatment for Patients Younger Than 60 Years Old With a High Tumor Burden |
Enrollment: | 172 |
Study Start Date: | June 1994 |
Study Completion Date: | May 2006 |
Primary Completion Date: | May 2003 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
standard chemotherapy arm, the CHVP (cyclophosphamide, low-dose doxorubicin, teniposide, and prednisone) regimen consisted of cyclophosphamide (600 mg/m2), doxorubicin (25 mg/m2), and teniposide (60 mg/m2), all administered intravenously on day 1, and prednisone (40 mg/m2), administered orally on days 1 to 5.4,12 Treatment consisted of a 6-course induction phase administered monthly, followed, for responders and patients presenting a stable disease, by a maintenance phase that consisted of 1 cycle every 2 months for 1 year. Concomitant subcutaneous interferon alfa-2b was administered at 5 x 106 3 times a week for 18 months.
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Procedure: chemotherapy
injection cyclophosphamide doxorubicin (25 mg/m2), and teniposide (60 mg/m2)(600 mg/m2)on day 1 and prednisone (40 mg/m2), administered orally on days 1 to 5.4,12 Treatment consisted of a 6-course induction phase administered monthly, followed, for responders and patients presenting a stable disease, by a maintenance phase that consisted of 1 cycle every 2 months for 1 year. Concomitant subcutaneous interferon alfa-2b was administered at 5 x 106 3 times a week for 18 months. |
2: Experimental
VCAP (cyclophosphamide, high-dose doxorubicin, prednisone, and vincristine) regimen as a first-line therapy combining vindesine (3 mg/m2) on day 1, cyclophosphamide (1500 mg/m2) on day 2, doxorubicin (80 mg/m2) on day 2, and prednisolone (50 mg/m2) on days 1 to 5, every 3 weeks.19,31,32 Patients in CR, VGPR, or PR after the second or third VCAP cycle continued on to stem-cell harvesting and received, before transplantation, one course of IMVP16 (ifosfamide, methotrexate, and VP-16), which combined ifosfamide (1.5 g/m2) and VP16 (100 mg/m2) on days 1 through 3, and methotrexate (30 mg/m2) on days 1 and 10. Patients with less than PR after the VCAP cycles received, as salvage therapy, 2 to 3 courses of DHAP (dexamethasone, high-dose cytarabine, and cisplatin) combining cisplatine (100 mg/m2) on day 1, cytarabine (4 g/m2) on day 2, and dexamethasone (40 mg/m2) on days 1 through 4. If at least a PR was obtained after DHAP, stem cells were harvested or patients were considered as failures |
Procedure: high dose therapy and autologous stem cell transplantation
VCAP regimen 3 cycles , less than PR: 2-3 DHAP, stem cell collection, in vitro purging autologous stem cell transplantation with TBI and cyclophosphamide
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Age 8-60 years old follicular lymphoma Not previously treated Stage II bulky, III or IV An Arbor classification high tumor burden
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
France | |
Philippe COLOMBAT | |
TOURS, France, 37000 | |
Emmanuel GYAN | |
TOURS, France, 37000 |
Principal Investigator: | Philippe COLOMBAT, MD PHD | Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS |
Responsible Party: | GOELAMS ( GOELAMS 064 Trial ) |
Study ID Numbers: | GOELAMS 064 |
Study First Received: | June 11, 2008 |
Last Updated: | October 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00696735 History of Changes |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
Phase III study patients with follicular lymphoma |
Interferon-alpha Prednisone Immunoproliferative Disorders Interferons Lymphoma, Follicular Cyclophosphamide Follicular Lymphoma Doxorubicin |
Teniposide Lymphatic Diseases Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Interferon Alfa-2a Lymphoma Interferon Alfa-2b |
Lymphatic Diseases Neoplasms Immunoproliferative Disorders Neoplasms by Histologic Type Immune System Diseases |
Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma |