NCT00476554 is a Phase 2 clinical trial of Sapacitabine in Cutaneous T-cell Lymphoma (CTCL), sponsored by Cyclacel Pharmaceuticals, Inc..

Who is sponsoring NCT00476554?

NCT00476554 is sponsored by Cyclacel Pharmaceuticals, Inc..

What drugs are being tested in NCT00476554?

Interventions in NCT00476554: Sapacitabine.

What condition does NCT00476554 study?

NCT00476554 studies Cutaneous T-cell Lymphoma (CTCL).

Is NCT00476554 still recruiting?

NCT00476554 is currently terminated. Last updated 7 December 2021.

Last reviewed 2021-12-07 · How we verify

NCT00476554

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Randomized Phase II Study of Oral Sapacitabine in Patients With Advanced Cutaneous T-cell Lymphoma

Terminated Phase 2 Last updated 7 December 2021

What this trial tests

Phase 2 trial testing Sapacitabine in Cutaneous T-cell Lymphoma (CTCL) in 16 participants. Terminated before completion.

Timeline

1 April 2007

Primary endpoint
1 March 2012

1 March 2012

Quick facts

Lead sponsor	Cyclacel Pharmaceuticals, Inc.
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	16
Start date	1 April 2007
Primary completion	1 March 2012
Estimated completion	1 March 2012
Sites	3 locations across United States

Drugs / interventions tested

Sapacitabine — full drug profile →

Conditions studied

Cutaneous T-cell Lymphoma (CTCL) — all drugs for Cutaneous T-cell Lymphoma (CTCL) →

Sponsor

Cyclacel Pharmaceuticals, Inc. — full company profile →

Who can join

18 and older, any sex, with Cutaneous T-cell Lymphoma (CTCL). Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

response rate in overall skin disease
Time frame: over the course of study
Decrease of lesion from baseline

Sponsor's own 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).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Response and Toxicity to Cytarabine Therapy in Leukemia and Lymphoma: From Dose Puzzle to Pharmacogenomic Biomarkers.
Di Francia R, Crisci S, De Monaco A, Cafiero C, et al · · 2021 · cited 76× · PMID 33669053 · DOI 10.3390/cancers13050966

Verify or expand the search:

Other trials of Sapacitabine

Trials testing the same drug.

NCT03641755 — Olaparib + Sapacitabine in BRCA Mutant Breast Cancer · Phase 1 · active not recruiting
NCT01303796 — A Study of Oral Sapacitabine in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia · Phase 3 · completed
NCT01253460 — Sapacitabine, Cyclophosphamide, Rituximab for Relapsed Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma (CLL/SLL · Phase 2 · terminated

Other recruiting trials for Cutaneous T-cell Lymphoma (CTCL)

Currently open trials in the same condition.

NCT06914037 — A Clinical Study of CHT101 in CD70-Positive Relapsed or Refractory Hematological Malignancies · Phase 1 · recruiting
NCT06485219 — A Phase IIa Clinical Study of Purinostat Mesylate for Injection in Patients With Peripheral T-Cell Lymphoma and Cutaneou · Phase 2 · active not recruiting

Other Cyclacel Pharmaceuticals, Inc. trials

Trials by the same sponsor.

NCT05817890 — Absorption, Metabolism, and Excretion of CYC065 in Healthy Male Subjects · EARLY_PHASE1 · completed
NCT04983810 — A Study to Investigate Fadraciclib (CYC065), in Subjects With Advanced Solid Tumors and Lymphoma · Phase 1, PHASE2 · unknown
NCT04017546 — CYC065 CDK Inhibitor and Venetoclax Study in Relapsed/Refractory AML or MDS · Phase 1 · completed
NCT03884829 — A Phase I Study of CYC140, a PLK-1 Inhibitor, in Advanced Leukemias or MDS · Phase 1 · terminated
NCT03739554 — CYC065 CDK Inhibitor and Venetoclax Study in Relapsed/Refractory CLL · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00476554 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Cyclacel Pharmaceuticals, Inc.
Last refreshed: 7 December 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00476554.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing