Bone Marrow Neoplasms, Hematologic Neoplasms, Non-Hodgkin's Lymphoma
Conditions
Keywords
APL, Lymphoma, T-cell Lymphoma, Peripheral T-cell Lymphoma
Brief summary
The study of safety of a new organic arsenic compound in the treatment of hematological malignancies.
Interventions
DRUGDarinaparsin
300mg/m2 of Darinaparsin given daily for five consecutive days to be repeated every 28 days for up to six months.
Sponsors
Alaunos Therapeutics
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Hodgkin's or non-Hodgkin's Lymphoma. 2. ≥ 1 prior therapy and currently requiring therapy. 3. Evaluable disease (defined by disease-specific criteria listed in Appendix 1) 4. ≥ 18 years of age. 5. ECOG performance score ≤ 2 (see Appendix 2). 6. Life-expectancy ≥ 2 months. 7. Written informed consent in compliance with ZIOPHARM policies and the Human Investigation Review Committee with jurisdiction over the site. 8. No anti-cancer therapy exception of hydroxyurea ≤ 3 weeks before Baseline (Day 1, Cycle 1). 9. The following clinical laboratory values \< 2 weeks before Baseline: * Creatinine ≤ 2X upper limit of normal (ULN). * Total bilirubin ≤ 2X ULN. * Alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 3X ULN.
Exclusion criteria
1. New York Heart Association (NYHA) functional class ≥3 myocardial infarction (see Appendix ) within 6 months before Baseline or uncontrolled cardiac arrhythmia other than asymptomatic atrial fibrillation; a QTc ≥450 msec; or a ≥grade-2 atrioventricular (AV) block or left bundle branch block (LBBB). 2. Pregnant and/or lactating female. (Women of childbearing age must use effective contraception from Screening through the duration of study participation). 3. Uncontrolled infection. 4. Prior seizures ≥ grade-3 in CTC v.3 criteria. 5. Arsenic allergy. 6. Significant neuropathology, defined as grade \> 2 per CTCAE Version 3.0. 7. Confusion or dementia. 8. Prior history of neurological deficits (e.g., stroke, dementia, ischemia) that has the potential to confound a post-dose neurological assessment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response Rate | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| toxicities | 6 months |
Countries
United States
Outcome results
None listed