A Phase I/II Study of GX15-070MS in Untreated CLL

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Study Completion Date

2006-01-31

Brief Summary

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This protocol is being run to determine the best phase II dose and schedule of obatoclax in patients with previously untreated CLL.

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Detailed Description

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Both 1 hour and 3 hour infusions of obatoclax every 3 weeks will be evaluated in ascending doses.

Conditions

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Chronic Lymphocytic Leukemia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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GX15-070MS

GX15-070MS at various doses and schedules

Group Type EXPERIMENTAL

GX15-070MS

Intervention Type DRUG

A 60-minute or 3-hour IV infusion every 2-3 weeks.

GX15-070MS

Intervention Type DRUG

GX15-070MS at various doses and schedules

Interventions

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GX15-070MS

A 60-minute or 3-hour IV infusion every 2-3 weeks.

Intervention Type DRUG

GX15-070MS

GX15-070MS at various doses and schedules

Intervention Type DRUG

Other Intervention Names

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Obatoclax Obatoclax

Eligibility Criteria

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Inclusion Criteria

* Histologically or cytologically confirmed B-CLL
* Previous standard systemic chemotherapy, including fludarabine. There are no limitations on additional, allowable type and amount of prior therapy. Acute toxicities from prior therapy must have resolved to ≤Grade 1
* Age ≥18 years
* ECOG Performance Status ≤1
* Life expectancy of \>8 weeks

Exclusion Criteria

* Patients receiving any other investigational agents (e.g., under another IND) or commercial agents or therapies administered with the intent to treat their malignancy
* Patients with history of seizure disorders
* Pregnant women and women who are breast feeding
* HIV-positive patients receiving combination anti-retroviral therapy

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No