Myelodysplastic SyndromesPhase 1/2NCT00035867
Study of TLK199 HCl Liposomes for Injection in Myelodysplastic Syndrome
A Phase 1/2 study testing TLK199 HCl Liposomes for Injection in people with Myelodysplastic Syndromes, run by Telik at 9 sites in United States.
Trial summary
The purpose of this study is to determine the safety and efficacy of TLK199 in patients with myelodysplastic syndrome (MDS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelodysplastic Syndromes
- What is being tested?
- TLK199 HCl Liposomes for Injection
- Type of treatment
- Injection or infusion
- How many people
- 65 participants
- Where
- 9 sitesUnited States
- Study dates
- Apr 2002to May 2007
- Phase
- Phase 1/2
- 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
- Histologically or cytologically confirmed diagnosis of MDS
- Adequate liver and kidney function
- Ineligible for, or refusing, allogeneic bone marrow transplant
- At least 18 years of age
- Discontinuation of growth factors (e.g., G- CSF) at least 2 weeks prior to study entry
Who cannot join
- Failure to recover from any prior surgery, or any major surgery within 4 weeks of study entry
- Pregnant or lactating women
- History of allergy to eggs
- Other investigational drugs within 14 days of study entry
- Chemotherapy, radiotherapy or immunotherapy within 14 days of study entry
- Concomitant steroids or hormones for the treatment of neoplasms
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35294
University of Chicago
Chicago, Illinois, 60637
Texas Cancer Associates
Dallas, Texas, 75231
M.D. Anderson Cancer Center
Houston, Texas, 77030
The Angeles Clinic & Research Institute
Los Angeles, California, 90404
The Sarah Cannon Cancer Center
Nashville, Tennessee, 37203
Oregon Health & Science University
Portland, Oregon, 97239
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
Midwest Cancer Research Group
Skokie, Illinois, 60077
About this study
Official title: Phase 1-2a Study of TLK199 HCl Liposomes for Injection in Myelodysplastic Syndrome
The purpose of this study is to determine the safety and efficacy of TLK199 in patients with myelodysplastic syndrome (MDS).
- Conditions
- Myelodysplastic Syndromes
- Being tested
- TLK199 HCl Liposomes for Injection
- Medical subject headings
- Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TLK199 HCl Liposomes for InjectionDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2002 (estimated)
- Study startApr 2002
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myelodysplastic SyndromesStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants
Sponsor and investigators
- Lead sponsor
- Telik
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00035867
- Sponsor's protocol ID
- TLK199.1001
- Status last verified
- Jun 2005
- First submitted
- 6 May 2002
- Last updated
- 3 Jun 2008
- Results posted
- No
Publications
Raza A, Galili N, Callander N, Ochoa L, Piro L, Emanuel P, Williams S, Burris H 3rd, Faderl S, Estrov Z, Curtin P, Larson RA, Keck JG, Jones M, Meng L, Brown GL. Phase 1-2a multicenter dose-escalation study of ezatiostat hydrochloride liposomes for injection (Telintra, TLK199), a novel glutathione analog prodrug in patients with myelodysplastic syndrome. J Hematol Oncol. 2009 May 13;2:20. doi: 10.1186/1756-8722-2-20.
PubMed 19439093
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1-2a Study of TLK199 HCl Liposomes for Injection in Myelodysplastic Syndrome
- ClinicalTrials.gov ID
- NCT00035867
- Acronym / sponsor ID
- TLK199.1001
- Conditions
- Myelodysplastic Syndromes
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants
- Lead sponsor
- TelikIndustry (pharma, biotech, devices)
- Study start
- Apr 2002
- Study completion
- May 2007 (actual)
- First posted
- 7 May 2002 (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 purpose of this study is to determine the safety and efficacy of TLK199 in patients with myelodysplastic syndrome (MDS).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologically or cytologically confirmed diagnosis of MDS
- Adequate liver and kidney function
- Ineligible for, or refusing, allogeneic bone marrow transplant
- At least 18 years of age
- Discontinuation of growth factors (e.g., G- CSF) at least 2 weeks prior to study entry
Key exclusion criteria (6 listed)
- Failure to recover from any prior surgery, or any major surgery within 4 weeks of study entry
- Pregnant or lactating women
- History of allergy to eggs
- Other investigational drugs within 14 days of study entry
- Chemotherapy, radiotherapy or immunotherapy within 14 days of study entry
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 |
|---|---|---|
| TLK199 HCl Liposomes for Injection | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2008.
- Derived from this study: PubMed 19439093Raza A, Galili N, Callander N, Ochoa L, Piro L, Emanuel P, Williams S, Burris H 3rd, Faderl S, Estrov Z, Curtin P, Larson RA, Keck JG, Jones M, Meng L, Brown GL. Phase 1-2a multicenter dose-escalation study of ezatiostat hydrochloride liposomes for injection (Telintra, TLK199), a novel glutathione analog prodrug in patients with myelodysplastic syndrome. J Hematol Oncol. 2009 May 13;2:20. doi: 10.1186/1756-8722-2-20.
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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.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing TLK199 HCl Liposomes for Injection in people with Myelodysplastic Syndromes, run by Telik at 9 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 5 inclusion and 6 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: finished, as of the sponsor's last update on 3 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00035867, which also lists 1 linked publication.
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 3 Jun 2008.