Clinical trial · Interventional
A Randomized Phase II Study of Oral Sapacitabine in Patients With Advanced Cutaneous T-cell Lymphoma
NCT00476554CI-TRIAL-00055630terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): slow accrual and financial resource limitation
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cutaneous T-cell Lymphoma (CTCL) | Primary Cutaneous T-Cell Non-Hodgkin Lymphoma | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sapacitabine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A: High dose
- description
- High-dose (Arm A): 200 mg b.i.d. x 3 consecutive days per week for 2 weeks followed by 1-week rest
- interventionNames
- Drug: Sapacitabine
- type
- EXPERIMENTAL
- label
- Arm B: High dose
- description
- Low-dose (Arm B): 100 mg b.i.d. x 3 consecutive days per week for 2 weeks followed by 1-week rest
- interventionNames
- Drug: Sapacitabine
Primary outcomes (1)
- measure
- response rate in overall skin disease
- timeFrame
- over the course of study
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 * 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 Exclusion Criteria: * 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
References
Publications (0)
Data not yet available
No reference posted for this study.