Clinical Trial: Dexamethasone, Ofatumumab and Bendamustine (DOT) First-line in Mantle-cell Lymphoma(MCL)

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Phase I/II Trial of Dexamethasone, Ofatumumab and Bendamustine [Treanda] (DOT) as First-line Treatment of Mantle-cell Lymphoma (MCL) in the Elderly

Brief Summary: The rationale for this study design is based on the fact that the maximum tolerated dose (MTD) of single-agent ofatumumab and bendamustine have been previously determined. The choice of the doses for the combination is based on the investigators unpublished clinical experience, as well as inferred from extensive experimental data on the use of other monoclonal antibodies in combination chemotherapy in lymphoma patients. The starting dose of the 2 main component drugs is the MTD of each drug as single agent.

Detailed Summary:
Sponsor: Southern Europe New Drug Organization

Current Primary Outcome:

  • Adverse events (Phase I) [ Time Frame: 60 days after last dose of investigational drug ]
    Incidence, severity, and attribution of treatment-emergent AEs
  • Complete Response rate (Phase II) [ Time Frame: 24 months ]
    Response determined according to the revised response criteria for malignant lymphoma (Cheson, JCO 2008)


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Duration of response (Phase II) [ Time Frame: At the screening, cycle 4 (12 weeks) , cycle 6 (18 weeks), 1 year Follow-up ]
    Duration estimated from the first confirmed tumor regression to the disease progression.
  • Serial peripheral blood CD34+ cell counts [ Time Frame: Cycles 1 (3 weeks), 4 (12 weeks) and 6 (18 weeks) ]
  • Molecular analysis of CD34+ cells [ Time Frame: cycle 4 (12 weeks) or cycle 6 (18 weeks for inadequate harvests after cycle 4) ]
  • Serial molecular analysis of peripheral blood cells [ Time Frame: Cycles 1 (3 weeks), 4 (12 weeks) and 6 (18 weeks) ]
    Serial molecular analysis by PCR
  • Ability to harvest ≥ 7 x106 CD34+ cells/kg [ Time Frame: Cycle 4 (12 weeks) or cycle 6 (18 weeks for inadequate harvests after cycle 4) ]
  • Presence of tumor cells in the peripheral blood [ Time Frame: Cycle 1 (3 weeks), 4 (12 weeks) and 6 (18 weeks) ]
    Monitored by morphology, immunophenotype and PCR


Original Secondary Outcome: Same as current

Information By: Southern Europe New Drug Organization

Dates:
Date Received: October 13, 2010
Date Started: April 2010
Date Completion: June 2012
Last Updated: September 12, 2011
Last Verified: September 2011