Treatment of Patients With Diffuse Large B Cell Lymphoma Who Are Not Suitable for Anthracycline Containing Chemotherapy

Sponsor
University College, London
Study ID
NCT01679119
Phase
PHASE2
Status
Completed

Conditions

  • Diffuse Large B Cell Lymphoma

Eligibility Criteria

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

Interventions

  • Cyclophosphamide — DRUG
    Cyclophosphamide 750mg/m2 IV, given day 1
  • Vincristine — DRUG
    Vincristine 1.4mg/m2(max 2mg)IV given day 1
  • Prednisolone — DRUG
    Prednisolone 100mg OD Oral given days 1-5
  • Rituximab — DRUG
    Rituximab 375mg/m2 IV given day 1
  • Inotuzumab Ozogamicin — DRUG
    Inotuzumab Ozogamicin 0.8mg/m2 IV given on day 2
  • Gemcitabine — DRUG
    Gemcitabine up to 1g/m2 IV given day 1 and day 8 (Patients with ECOG PS 0-1: starting dose: 875mg/m2 (1st cycle). If tolerated can be escalated to 1g/m2 in cycle 2 and subsequent cycles. Patients with ECOG PS 2: starting dose 750mg/m2 (1st cycle). If tolerated can be escalated to 875mg/m2 in cycle 2 and then escalated to 1g/m2 in cycle 3 and subsequent cycles.)

Study Details

The purpose of this trial is to compare the efficacy and safety of Inotuzumab Ozogamicin in combination with R-CVP with that of R-G-CVP for the treatment of Diffuse Large B Cell Lymphoma (DLBCL) in a population of patients not suitable for anthracycline based chemotherapy. There is no standard of care for the treatment of this group of patients. If demonstrated to be efficacious and safe to deliver this regimen will be further tested in a phase III trial to determine whether this should become the standard of care amongst patients with DLBCL not fit for anthracycline (R-CHOP).

Key Dates

Start date
Oct 31, 2013
Status verified
May 2025
Primary completion
Mar 31, 2019
Completion
Mar 31, 2022

Study Design

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

Arms

  • Experimental: IO-R-CVP
    Inotuzumab Ozogamicin plus Rituximab and CVP (Cyclophosphamide, vincristine \& prednisolone).
  • Active Comparator: Gem-R-CVP
    Gemcitabine plus Rituximab and CVP (Cyclophosphamide, Vincristine and Prednisolone).

Primary Outcome Measure

Progression Free Survival [ Time Frame: At 2 years following date of randomisation. ]

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