Hematologic NeoplasmsPhase 2NCT00421213
Phase II Study of ZIO-101 in Advanced Blood and Bone Marrow Cancers
A Phase 2 study testing Darinaparsin in people with Hematologic Neoplasms and Bone Marrow Neoplasms, run by Alaunos Therapeutics at 6 sites in United States.
Trial summary
The study of safety of a new organic arsenic compound in the treatment of hematological malignancies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematologic Neoplasms, Bone Marrow Neoplasms, Non-Hodgkin's Lymphoma
- What is being tested?
- Darinaparsin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 6 sitesUnited States
- Study dates
- 29 Dec 2006to 30 Jun 2009
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hodgkin's or non-Hodgkin's Lymphoma.
- ≥ 1 prior therapy and currently requiring therapy.
- Evaluable disease (defined by disease-specific criteria listed in Appendix 1)
- ≥ 18 years of age.
- ECOG performance score ≤ 2 (see Appendix 2).
- Life-expectancy ≥ 2 months.
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- Written informed consent in compliance with ZIOPHARM policies and the Human Investigation Review Committee with jurisdiction over the site.
- No anti-cancer therapy exception of hydroxyurea ≤ 3 weeks before Baseline (Day 1, Cycle 1).
- 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.
Who cannot join
- 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).
- Pregnant and/or lactating female. (Women of childbearing age must use effective contraception from Screening through the duration of study participation).
- Uncontrolled infection.
- Prior seizures ≥ grade-3 in CTC v.3 criteria.
- Arsenic allergy.
- Significant neuropathology, defined as grade > 2 per CTCAE Version 3.0.
- Confusion or dementia.
- Prior history of neurological deficits (e.g., stroke, dementia, ischemia) that has the potential to confound a post-dose neurological assessment.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Study site
Bethesda, Maryland
Study site
Chicago, Illinois
Study site
Fargo, North Dakota
Study site
Miami, Florida
Study site
Morgantown, West Virginia
Study site
Sioux Falls, South Dakota
About this study
The study of safety of a new organic arsenic compound in the treatment of hematological malignancies.
- Being tested
- Darinaparsin
- Keywords
- APL, Lymphoma, T-cell Lymphoma, Peripheral T-cell Lymphoma
- Medical subject headings
- Hematologic Neoplasms, Bone Marrow Neoplasms, Lymphoma, Non-Hodgkin, Lymphoma, Lymphoma, T-Cell, Lymphoma, T-Cell, Peripheral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DarinaparsinDrug
Also called ZIO-101
300mg/m2 of Darinaparsin given daily for five consecutive days to be repeated every 28 days for up to six months.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | Not described Receives: Drug: Darinaparsin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response Rate
Measured: 6 months
Secondary outcomes (1)
toxicities
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2007 (estimated)
- Study start29 Dec 2006
- Primary completion30 Jun 2009
- Study completion30 Jun 2009
Why it stopped: Sponsor stopped enrollment at 50 of 70 planned patients because an activity signal had been observed in lymphoma and further enrollment would not add significantly to interpretation of efficacy or safety.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alaunos Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00421213
- Sponsor's protocol ID
- SGL2003
- Status last verified
- Sep 2026
- First submitted
- 10 Jan 2007
- Last updated
- 1 Oct 2026
- Results posted
- No