Treatment of Mantle Cell Lymphoma at Diagnosis for Patients Under 65 Years
NCT ID: NCT00285389
Last Updated: 2009-02-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
39 participants
INTERVENTIONAL
2002-02-28
2008-12-31
Brief Summary
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Detailed Description
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The responders more than RP \> 50% received 2 other cycles before to be intensified with alkeran 140 mg/ m2 and a 8 grays TBI over 4 days before an autologous PBSCT.The stem cell collection is realised after a mobilisation with HD Cyclophosphamide (4 mg/m2) after the four R-(VAD + C) cycles and purged by a rituximab injection 10 days before the collection.
There is an clinical and molecular evaluation of the strategy
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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VAD Clorambucil Rituximab
Adriblastin
dexamethasone
Chlorambucil
rituximab
cyclophosphamide
alkeran
Total body irradiation (8Gy/4fr)
vincristine
0,4 mg/day day 1 to day 4
Interventions
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Adriblastin
dexamethasone
Chlorambucil
rituximab
cyclophosphamide
alkeran
Total body irradiation (8Gy/4fr)
vincristine
0,4 mg/day day 1 to day 4
Eligibility Criteria
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Inclusion Criteria
* CD 20+
* At diagnosis or without anterior chemotherapy
* Age \>18 and \< 66 years
* Ann Arbor ii, III or IV
* ECOG \<3
* contraindication for rituximab treatment
* Informed consent signed
* No cancer anteriory
* Renal and hepatic function compatible with the treatment
* Ventricular Fraction \> 50 % with echographic method and \> 40% with isotopic method
Exclusion Criteria
* age\<18 ou \> 66 years
* Informed consent not signed
* anterior cancer
* Contraindication to rituximab
* Cardiac insufficiency
18 Years
65 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
French Innovative Leukemia Organisation
OTHER
Responsible Party
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GOELAMS
Principal Investigators
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Remy GRESSIN, MD
Role: PRINCIPAL_INVESTIGATOR
French Innovative Leukemia Organisation
Locations
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Regional university hospital
Besançon, , France
Regional university hospital
Rennes, , France
REgional Hospital
Tours, , France
Countries
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References
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Gressin R, Caulet-Maugendre S, Deconinck E, Tournilhac O, Gyan E, Moles MP, El Yamani A, Cornillon J, Rossi JF, Le Gouill S, Lepeu G, Damaj G, Celigny PS, Maisonneuve H, Corront B, Vilque JP, Casassus P, Lamy T, Colonna M, Colombat P; French GOELAMS Group. Evaluation of the (R)VAD+C regimen for the treatment of newly diagnosed mantle cell lymphoma. Combined results of two prospective phase II trials from the French GOELAMS group. Haematologica. 2010 Aug;95(8):1350-7. doi: 10.3324/haematol.2009.011759. Epub 2010 Mar 10.
Other Identifiers
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MANTEAU 2001
Identifier Type: -
Identifier Source: org_study_id
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