Chronic Lymphocytic Leukemia Clinical Trial
Official title:
A Phase 1/2, Open Label, Dose Escalation Study of AQ4N for Safety, Tolerability, Pharmacokinetics and Activity in Patients With Lymphoid Neoplasms
The purpose of this study is to find answers to the following questions:
- What is the largest dose of AQ4N that can be given safely one time every three weeks
for 24 weeks?
- What are the side effects of AQ4N when given according to this schedule?
- How much AQ4N is in the blood at certain times after administration and how does the
body get rid of the drug?
- Will AQ4N help treat lymphoid cancer?
All patients in this study will receive AQ4N one time every three weeks for a maximum of 24
weeks. Each patient will receive the same dose for the entire time he/she is on the study.
However, some patients may receive a different dose than other patients depending upon when
they enter the study.
When the study begins, the first three patients will receive a dose of 400 mg/m2. After they
have all been observed for 2 weeks, and if side effects do not occur or are tolerable,
another three patients will enter the study at a higher dose. The increase in dose may
continue with new patient groups until side effects reach a point where they are not
tolerated. At that point no higher doses will be tried and more patients will be allowed to
enter at one or two lower doses where the side effects were tolerated.
Up to 55 patients will be entered in this study at up to 8 research centers in the United
States. Study duration will be approximately 27 weeks or 8 treatment cycles (One treatment
cycle lasts 3 weeks and begins on Day 1 with an infusion of AQ4N.)
The following procedures will be completed at the time of screening and throughout the
study: review of medical and cancer history, previous cancer treatments, and current
medications, a complete physical exam, and blood (4 to 6 teaspoons) and urine tests. Two
additional tests to evaluate the heart, an electrocardiogram (ECG) and a multiple gated
acquisition assessment (MUGA) will be performed. Cancer progression will be monitored by a
computed tomography scan (CT scan) and a bone marrow biopsy.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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