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
- Are there results?
- None posted in the registry
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
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of ZIO-101 in Advanced Blood and Bone Marrow Cancers
- ClinicalTrials.gov ID
- NCT00421213
- Acronym / sponsor ID
- SGL2003
- Keywords
- APL, Lymphoma, T-cell Lymphoma, Peripheral T-cell Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason 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.
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Alaunos TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 29 Dec 2006 (actual)
- Primary completion
- 30 Jun 2009 (actual)
- Study completion
- 30 Jun 2009 (actual)
- First posted
- 11 Jan 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study of safety of a new organic arsenic compound in the treatment of hematological malignancies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Drug: Darinaparsin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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).
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DarinaparsinAlso: ZIO-101300mg/m2 of Darinaparsin given daily for five consecutive days to be repeated every 28 days for up to six months. | Drug | Single Arm |
Primary outcome
Response Rate
Time frame: 6 months
1 secondary outcome
toxicities
Time frame: 6 months
Results and safety
The study was stopped early (reason given: 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.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: 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.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response Rate (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.