Rituximab in Pretreated Elderly or Unfit B-CLL Patients

Sponsor
Prof. Dr. Med. Laimonas Griskevicius
Study ID
NCT01576588
Phase
PHASE2
Status
Completed

Conditions

  • B-Cell Chronic Lymphocytic Leukemia

Eligibility Criteria

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

Interventions

  • Rituximab — DRUG
    Rituximab (Rtx) antibody infusions will be administered on Day 1, 2, 3 (cycle 1) and Day 1 (cycles 2 to 4).
  • Glucocorticoid — DRUG
    Glucocorticoid (either Dexamethasone or Methyl-prednisolone) infusions will be administered on Days 1 to 3 (cycles 1-4(6)) and should precede the Rituximab infusion.

Study Details

The study will test the efficacy rituximab in addition to glucocorticoids for the treatment of B-CLL in elderly or unfit patients.

Key Dates

Start date
Oct 31, 2011
Status verified
Dec 2019
Primary completion
Jan 31, 2016
Completion
Jun 30, 2019

Study Design

Enrollment
25 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: R-HDMP
    Rituximab (Rtx) antibody infusions will be administered on Day 1, 2, 3 (cycle 1) and Day 1 (cycles 2 to 4). Glucocorticoid (either Dexamethasone or Methyl-prednisolone) infusions will be administered on Days 1 to 3 (cycles 1-4(6)) and should precede the Rituximab infusion.

Primary Outcome Measure

Overall Response Rate [ Time Frame: 3 months +/- 2 weeks after the last treatment cycle. ]

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