Chronic Lymphocytic Leukemia
Conditions
Keywords
CLL, obatoclax
Brief summary
This protocol is being run to determine the best phase II dose and schedule of obatoclax in patients with previously untreated CLL.
Detailed description
Both 1 hour and 3 hour infusions of obatoclax every 3 weeks will be evaluated in ascending doses.
Interventions
DRUGGX15-070MS
A 60-minute or 3-hour IV infusion every 2-3 weeks.
Sponsors
Gemin X
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determine the recommended Phase II dose of GX15-070MS administered as a 60-minute and/or 3-hour infusion every 2 to 3 weeks | 14 days |
Secondary
| Measure | Time frame |
|---|---|
| Estimate the response rate of previously-treated patients with CLL at the recommended Phase II dose of GX15-070MS administered as a 60-minute and/or 3-hour infusion every 2 to 3 weeks. | 14 days |
Countries
Canada, United States
Outcome results
None listed