CClinicalTrials.gg
TerminatedNCT00421213Updated Oct 1, 2026

Phase II Study of ZIO-101 in Advanced Blood and Bone Marrow Cancers

A Phase 2 interventional study of Darinaparsin in Hematologic Neoplasms, Bone Marrow Neoplasms and Non-Hodgkin's Lymphoma, sponsored by Alaunos Therapeutics. Terminated at 6 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-01.

Sponsored by Alaunos Therapeutics · Phase 2, Interventional, and Treatment

Why this study was terminated
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.
Updated Sep 30, 2026Now TerminatedPrimary completion moved+1 moreGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

The study of safety of a new organic arsenic compound in the treatment of hematological malignancies.

02

Conditions studied

  • Hematologic Neoplasms
  • Bone Marrow Neoplasms
  • Non-Hodgkin's Lymphoma

Keywords

  • APL
  • Lymphoma
  • T-cell Lymphoma
  • Peripheral T-cell Lymphoma
03

In context

Hematologic Neoplasms

1,464 studies on the registry are indexed under Hematologic Neoplasms; 433 are open to participants now.

This study's enrollment of 50 is above the median of 45 across 1,068 interventional studies indexed under Hematologic Neoplasms.

Browse Hematologic Neoplasms studies →

Lead sponsor

Alaunos Therapeutics is the lead sponsor of 37 studies on the registry; none are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 5 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    Single Arm

    Drug: Darinaparsin

Interventions

  • DrugDarinaparsin

    300mg/m2 of Darinaparsin given daily for five consecutive days to be repeated every 28 days for up to six months.

    Also known as: ZIO-101

06

What researchers measure

Primary outcomes

  1. Response Rate

    Time frame: 6 months

Secondary outcomes

  1. toxicities

    Time frame: 6 months

07

Study locations

6 sites
  • Miami, Florida, United States
  • Chicago, Illinois, United States
  • Bethesda, Maryland, United States
  • Fargo, North Dakota, United States
  • Sioux Falls, South Dakota, United States
  • Morgantown, West Virginia, United States
08

Updates

3 registry updates since Sep 25, 2026
Status
Completed→Terminated 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.
changed Sep 30, 2026
Primary completion
Apr 2012→Jun 30, 2009
Sep 30, 2026
Study completion
Apr 2012→Jun 30, 2009
Sep 30, 2026
Show all 3 updates
  1. Oct 1, 2026
    Minor edits only
    + 1 other change: design details
  2. Sep 30, 2026
    Completed→Terminated
    Why 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.
    Primary completion Apr 2012→Jun 30, 2009
    Study completion Apr 2012→Jun 30, 2009
  3. Sep 29, 2026
    Minor edits only
    + 4 other changes: verification date, registry dates, site details and index terms

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT00421213
Lead sponsor
Alaunos Therapeutics
Responsible party
Sponsor
First posted
Jan 11, 2007
Start date
Dec 29, 2006
Primary completion
Jun 30, 2009
Completion
Jun 30, 2009
Last update
Oct 1, 2026
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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