Efficacy and Safety of R-HAD Alone or in Combination With Bortezomib in Patients With Relapsed or Refractory MCL

Sponsor
Prof. Dr. M. Dreyling (co-chairman)
Study ID
NCT01449344
Phase
PHASE3
Status
Unknown

Conditions

  • Mantle Cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — DRUG
    Rituximab 375mg/m² IV , day 1
  • High dose Ara-C — DRUG
    Ara-C 2000 mg/m² (patients \>65 years or s/p myeloablative treatment: 1000 mg/m²) IV, d 2 and 3
  • Dexamethasone — DRUG
    Dexamethasone 40 mg PO, day 1-4
  • Bortezomib — DRUG
    Bortezomib 1.5 mg/m² IV, day 1 and 4

Study Details

The purpose of this study is to evaluate the efficacy and safety of rituximab, high-dose ara-c and dexamethasone (r-had) alone or in combination with bortezomib in patients with relapsed or refractory mantle cell lymphoma.

Key Dates

Start date
May 9, 2009
Status verified
Mar 2017
Primary completion
Dec 31, 2018
Completion
Dec 31, 2018

Study Design

Enrollment
128 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: R-HAD + Bortezomib
  • Active Comparator: R-HAD

Primary Outcome Measure

Change from Baseline of diseased nodes and nodal masses. [ Time Frame: approx. 66 and 126 days after start of therapy ]

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