A Phase I Clinical Trial of SyB L-0501 in Combination With Rituximab to Patients With Aggressive B-cell Non-Hodgkin's Lymphoma

Sponsor
SymBio Pharmaceuticals
Study ID
NCT00794638
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
20 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • SyB L-0501 — DRUG
    The administration of SyB L-0501 90 mg/m2 or 120 mg/m2/day on Day 2 and Day 3 will be followed by 18 days of observation. In the absence of adverse events or progressive disease, treatment will be repeated up to a maximum of 6 cycles, where 1 cycle is the 21-day treatment period (3 days of administration and 18 days of observation).
  • Rituximab — DRUG
    The administration of rituximab 375 mg/m2 on Day 1 of each cycle will be followed by 18 days of observation. In the absence of adverse events or progressive disease, treatment will be repeated up to a maximum of 6 cycles, where 1 cycle is the 21-day treatment period (3 days of administration and 18 days of observation).

Study Details

The purpose of this study is to assess the safety of SyB L-0501 in combination with Rituximab to patients with aggressive B-cell non-Hodgkin's lymphoma, and to explore the recommended dose for the Phase II clinical trial.

Key Dates

Start date
Nov 30, 2008
Status verified
Jul 2021
Primary completion
Mar 31, 2010
Completion
May 31, 2010

Study Design

Enrollment
9 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Primary Outcome Measure

Dose-limiting toxicity [ Time Frame: Treatment period ]

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