Cutaneous T-cell Lymphoma (CTCL)Phase 2NCT00476554
A Randomized Phase II Study of Oral Sapacitabine in Patients With Advanced Cutaneous T-cell Lymphoma
A Phase 2 study testing Sapacitabine in people with Cutaneous T-cell Lymphoma (CTCL), run by Cyclacel Pharmaceuticals, Inc. at 3 sites in United States.
Trial summary
This is an open label, randomized phase II study designed to evaluate the tolerability and response rate of high-dose and low-dose regimens in patients with advanced cutaneous T-cell lymphoma (CTCL). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cutaneous T-cell Lymphoma (CTCL)
- What is being tested?
- Sapacitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 3 sitesUnited States
- Study dates
- Apr 2007to 1 Mar 2012
- 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
- Adult patients with advanced CTCL
- Have had at least 2 systemic therapies
- Must have evaluable disease
- Eastern Cooperative Oncology Group performance status 0-2
- Adequate bone marrow, hepatic and renal function
- At least 3 weeks from prior therapies
Show all 11Show fewer
- Not receiving topical steroids or have been on a stable dose of topical steroids for at least 2 weeks
- Able to swallow capsules
- At least 3 weeks from major surgery
- Agree to practice effective contraception
- Able to understand and willing to sign the informed consent form
Who cannot join
- Receiving systemic steroids
- Receiving topical or systemic retinoids or vitamin A
- Receiving radiotherapy, biological therapy,or any other investigational agents
- Uncontrolled intercurrent illness
- Pregnant or lactating women
- Known to be HIV-positive
- Active hepatitis B and/or hepatitis C infection
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Timothy Kuzel, M.D.
Chicago, Illinois, 60611
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030-4009
Stanford University Hospitals and Clinics
Stanford, California, 94305
About this study
This is an open label, randomized phase II study designed to evaluate the tolerability and response rate of high-dose and low-dose regimens in patients with advanced cutaneous T-cell lymphoma (CTCL).
Read the detailed description
This is an open label, randomized phase II study designed to evaluate the tolerability and response rate of high-dose and low-dose regimens in patients with advanced cutaneous T-cell lymphoma (CTCL) who have had progressive, recurrent, or persistent disease on or following 2 systemic therapies.
- Conditions
- Cutaneous T-cell Lymphoma (CTCL)
- Being tested
- Sapacitabine
- Keywords
- CTCL
- Medical subject headings
- Lymphoma, T-Cell, Cutaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SapacitabineDrug
Also called CYC682
Sapacitabine
| Study group | Role | What they receive |
|---|---|---|
| Arm A: High dose | Experimental | High-dose (Arm A): 200 mg b.i.d. x 3 consecutive days per week for 2 weeks followed by 1-week rest Receives: Drug: Sapacitabine |
| Arm B: High dose | Experimental | Low-dose (Arm B): 100 mg b.i.d. x 3 consecutive days per week for 2 weeks followed by 1-week rest Receives: Drug: Sapacitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
response rate in overall skin disease
Decrease of lesion from baseline
Measured: over the course of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2007 (estimated)
- Study startApr 2007
- Primary completion1 Mar 2012
- Study completion1 Mar 2012
Why it stopped: slow accrual and financial resource limitation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous T-cell Lymphoma (CTCL)Studies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cyclacel Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Judy H Chiao, M.D., Study director, Cyclacel Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00476554
- Sponsor's protocol ID
- CYC682-06-05
- Status last verified
- Dec 2021
- First submitted
- 19 May 2007
- Last updated
- 22 Dec 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Study of Oral Sapacitabine in Patients With Advanced Cutaneous T-cell Lymphoma
- ClinicalTrials.gov ID
- NCT00476554
- Acronym / sponsor ID
- CYC682-06-05
- Conditions
- Cutaneous T-cell Lymphoma (CTCL)
- Keywords
- CTCL
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: slow accrual and financial resource limitation
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Cyclacel Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2007
- Primary completion
- 1 Mar 2012 (actual)
- Study completion
- 1 Mar 2012 (actual)
- First posted
- 22 May 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.
This is an open label, randomized phase II study designed to evaluate the tolerability and response rate of high-dose and low-dose regimens in patients with advanced cutaneous T-cell lymphoma (CTCL).
Detailed description
This is an open label, randomized phase II study designed to evaluate the tolerability and response rate of high-dose and low-dose regimens in patients with advanced cutaneous T-cell lymphoma (CTCL) who have had progressive, recurrent, or persistent disease on or following 2 systemic therapies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: High dose | Experimental | Drug: SapacitabineHigh-dose (Arm A): 200 mg b.i.d. x 3 consecutive days per week for 2 weeks followed by 1-week rest |
| Arm B: High dose | Experimental | Drug: SapacitabineLow-dose (Arm B): 100 mg b.i.d. x 3 consecutive days per week for 2 weeks followed by 1-week rest |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Adult patients with advanced CTCL
- Have had at least 2 systemic therapies
- Must have evaluable disease
- Eastern Cooperative Oncology Group performance status 0-2
- Adequate bone marrow, hepatic and renal function
Key exclusion criteria (7 listed)
- Receiving systemic steroids
- Receiving topical or systemic retinoids or vitamin A
- Receiving radiotherapy, biological therapy,or any other investigational agents
- Uncontrolled intercurrent illness
- Pregnant or lactating women
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 |
|---|---|---|
| SapacitabineAlso: CYC682Sapacitabine | Drug | Arm A: High dose, Arm B: High dose |
Primary outcome
response rate in overall skin disease
Time frame: over the course of study
Decrease of lesion from baseline
Results and safety
The study was stopped early (reason given: slow accrual and financial resource limitation). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2021.
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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.
Judy H Chiao, M.D. study director
Cyclacel Pharmaceuticals, Inc.
3 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 Sapacitabine in people with Cutaneous T-cell Lymphoma (CTCL), run by Cyclacel Pharmaceuticals, Inc. at 3 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 11 inclusion and 7 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 22 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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: slow accrual and financial resource limitation). 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 in overall skin disease (time frame: over the course of study). 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 22 Dec 2021.