Study Evaluating The Safety And Tolerability Of Combination Therapy Inotuzumab Ozogamicin (CMC-544) And Rituximab

Sponsor
Pfizer
Study ID
NCT00724971
Phase
PHASE1
Status
Completed

Conditions

  • Lymphoma, B-Cell

Eligibility Criteria

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

Interventions

  • Inotuzumab Ozogamicin (CMC-544) — DRUG
    1.8 mg/m2, IV on day 2 of each 28 day cycle; up to 8 cycles unless PD, unacceptable toxicity, or subject's refusal occurs.
  • Rituximab (Rituxan) — DRUG
    375 mg/m2, IV on day 1 of each 28 day cycle; up to 8 cycles unless PD, unacceptable toxicity, or subject's refusal occurs.

Study Details

To assess the tolerability and the initial safety profile of Inotuzumab Ozogamicin (CMC-544) in combination with Rituximab in patients with B-Cell Non-Hodgkin's lymphoma (NHL).

Key Dates

First listed
Jul 30, 2008
Start date
Jul 4, 2008
Status verified
Nov 2018
Primary completion
Mar 10, 2010
Completion
Mar 10, 2010

Study Design

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

Arms

  • Experimental: Inotuzumab Ozogamicin + Rituximab

Primary Outcome Measure

Number of Participants With Dose-limiting Toxicities (DLT) [ Time Frame: Up to 28 days ]

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