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A Study to Evaluate the Safety, Tolerability, and Antitumor Activity of Continuous Intravenous Infusion of MEDI-538 in Adults With B-Cell Chronic Lymphocytic Leukemia (CLL)

NCT00676871 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2008-09-05

No results posted yet for this study

Summary

Phase 1:

* Evaluate the safety and tolerability of MEDI-538 given by escalated doses with continuous IV infusion for 4 weeks in adult patients with CLL.
* Determine the maximum tolerated dose (MTD) of MEDI-538 administered by continuous IV infusion for 4 weeks in this patient population
* Describe the pharmacokinetics (PK) of MEDI-538
* Describe the immunogenicity (IM) of MEDI-538
* Determine the overall response, which is defined as follows: (1) conversion from PD/SD to PR/nPR/CR or conversion from PR to nPR/CR using standard NCI-WG criteria; or (2) conversion from MRD positivity to MRD negativity using 4-color flow cytometry; and
* Describe any antitumor activity (ie, time to response and duration of response) of MEDI-538 in this patient population.

Phase 2:

* To determine the overall response in adult patients with CLL who have residual disease following previous therapy for CLL.
* Describe the safety,PK,and IM of MEDI-538
* Determine the time to MRD relapse
* Determine the antitumor activity (ie, time to response, duration of response,and time to progression \[TTP\])of MEDI-538 in this patient population.

Conditions

Interventions

DRUG

MEDI-538

Dose one of MEDI 538 as a continuous IV infusion - dose level is 5 mg/m2/24h (Phase 1)

DRUG

MEDI-538

Dose two of MEDI 538 as a continuous IV infusion - dose level is 10 mg/m2/24h (Phase 1)

DRUG

MEDI-538

Dose three of MEDI 538 as a continuous IV infusion-dose level is 15mg/m2/24h (Phase 1)

DRUG

MEDI-538

Dose four of MEDI 538 as a continuous IV infusion - dose level is 30 mg/m2/24h(Phase 1)

DRUG

MEDI-538

Dose five of MEDI 538 as a continuous IV infusion - dose level is 45 mg/m2/24h (Phase 1)

DRUG

MEDI-538

Dose six of MEDI 538 as a continuous IV infusion - dose level is 60 mg/m2/24h (Phase 1)

DRUG

MEDI-538

Phase 2 part of the study, 20 to 60 patients will be treated with MEDI 538 as a continuous IV infusion through a central line catheter. The dose of MEDI-538 will be determined in the Phase 1 part of the study.

Sponsors & Collaborators

  • MedImmune LLC

    lead INDUSTRY

Principal Investigators

  • Karen Kaucic, M.D. · MedImmune LLC

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2010-03-31
Completion
2011-06-30

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00676871 on ClinicalTrials.gov