Treatment of Mantle Cell Lymphoma at Diagnosis for Patients Under 65 Years

NCT00285389 | Completed Phase 2 DMC

• 1 other identifier: MANTEAU 2001
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 3

Brief Summary

Phase II study to test in first line the VAD (Vincristine Adriablastine Dexamethasone) + C (Chlorambucil ) regimen associated to rituximab ( R-VAD + C ) in a cohort of young patients under 66 years with a mantle cell lymphoma and also the test the role of an in vivo marrow purge with rituximab before an autologous stem cell transplantation for the consolidation of the patients which fulfilled a response to 4 cycles of (R VAD + C) regimen.

Conditions

Mantle Cell Lymphoma

Keywords

Mantle cell lymphoma; Chemotherapy; Autologous PBSCT; Molecular evaluation

Outcome Measures

Primary Outcomes (1)

• failure event free survival at 3 years

  3 YEARS

Secondary Outcomes (5)

• Response rate after 4 R-(VAD+C) cycles

  4 months

• Incident of Molecular residual disease on blood, marrow and stem cell collection

  3 years

• Safety of the R-( VAD+C) regimen

  8 months

• Overall survival

  3 years

• Efficacy of the stem cell collection after HD Cyclosphosphamide mobilization and rituximab purging

  8 months

Study Arms (1)

VAD Clorambucil Rituximab

EXPERIMENTAL

Drug: Adriblastin; Drug: dexamethasone; Drug: Chlorambucil; Drug: rituximab; Drug: cyclophosphamide; Drug: alkeran; Procedure: Total body irradiation (8Gy/4fr); Drug: vincristine

Interventions

Adriblastin DRUG

VAD Clorambucil Rituximab

dexamethasone DRUG

VAD Clorambucil Rituximab

Chlorambucil DRUG

VAD Clorambucil Rituximab

rituximab DRUG

VAD Clorambucil Rituximab

cyclophosphamide DRUG

VAD Clorambucil Rituximab

alkeran DRUG

VAD Clorambucil Rituximab

Total body irradiation (8Gy/4fr) PROCEDURE

VAD Clorambucil Rituximab

vincristine DRUG

0,4 mg/day day 1 to day 4

VAD Clorambucil Rituximab

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Mantel cell lymphoma
• 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

You may not qualify if:

• Other type of lymphoma
• age\<18 ou \> 66 years
• Informed consent not signed
• anterior cancer
• Contraindication to rituximab
• Cardiac insufficiency

Sponsors & Collaborators

• French Innovative Leukemia Organisation: lead
• Hoffmann-La Roche: collaborator

Study Sites (3)

Regional university hospital

Besançon, 25000, France

Location

Regional university hospital

Rennes, 35033, France

Location

REgional Hospital

Tours, 37000, France

Location

Related Publications (1)

• 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.

  PMID: 20220059 DERIVED

MeSH Terms

Conditions

Lymphoma, Mantle-Cell

Interventions

Doxorubicin; Dexamethasone; Chlorambucil; Rituximab; Cyclophosphamide; Melphalan; Whole-Body Irradiation; Vincristine

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Phosphoramide Mustards; Phosphoramides; Organophosphorus Compounds; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Radiotherapy; Therapeutics; Investigative Techniques; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Study Officials

• Remy GRESSIN, MD

  French Innovative Leukemia Organisation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 31, 2006
• First Posted: February 2, 2006
• Study Start: February 1, 2002
• Primary Completion: December 1, 2005
• Study Completion: December 1, 2008
• Last Updated: February 12, 2009

Record last verified: 2009-02

Locations

FR (3)