Who is sponsoring NCT01211457?

NCT01211457 is sponsored by Cyclacel Pharmaceuticals, Inc..

What drugs are being tested in NCT01211457?

Interventions in NCT01211457: sapacitabine and decitabine (Part 1 - completed), sapacitabine and venetoclax (Part 2 - recruiting).

What condition does NCT01211457 study?

NCT01211457 studies Acute Myeloid Leukemia, Myelodysplastic Syndromes.

Is NCT01211457 still recruiting?

NCT01211457 is currently status unknown. Last updated 16 July 2019.

Last reviewed 2019-07-16 · How we verify

NCT01211457

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

Study of Sapacitabine in Acute Myeloid Leukemia (AML) or Myelodysplastic Syndromes (MDS)

Status unknown Phase 1, PHASE2 Last updated 16 July 2019

What this trial tests

Phase 1, PHASE2 trial testing sapacitabine and decitabine (Part 1 - completed) in Acute Myeloid Leukemia in 65 participants. Status unknown.

Timeline

17 June 2010

Primary endpoint
20 June 2020

31 December 2020

Quick facts

Lead sponsor	Cyclacel Pharmaceuticals, Inc.
Phase	Phase 1, PHASE2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	65
Start date	17 June 2010
Primary completion	20 June 2020
Estimated completion	31 December 2020
Sites	3 locations across United States

Drugs / interventions tested

sapacitabine and decitabine (Part 1 - completed) — full drug profile →
sapacitabine and venetoclax (Part 2 - recruiting) — full drug profile →

Conditions studied

Acute Myeloid Leukemia — all drugs for Acute Myeloid Leukemia →
Myelodysplastic Syndromes — all drugs for Myelodysplastic Syndromes →

Sponsor

Cyclacel Pharmaceuticals, Inc. — full company profile →

Who can join

18 and older, any sex, with Acute Myeloid Leukemia or Myelodysplastic Syndromes. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a combination study to evaluate sapacitabine administered in alternating cycles with decitabine in previously untreated Acute Myeloid Leukemia (AML) or concomitantly with venetoclax in previously treated AML or MDS

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Beyond the Edge of Hypomethylating Agents: Novel Combination Strategies for Older Adults with Advanced MDS and AML.
Kubasch AS, Platzbecker U. · · 2018 · cited 14× · PMID 29795051 · DOI 10.3390/cancers10060158
Historical expectations with DNA methyltransferase inhibitor monotherapy in MDS: when is combination therapy truly "promising"?
Brunner AM, Fell G, Steensma DP. · · 2022 · cited 3× · PMID 35143613 · DOI 10.1182/bloodadvances.2021006357

Verify or expand the search:

Other recruiting trials for Acute Myeloid Leukemia

Currently open trials in the same condition.

NCT07020533 — A Vaccine (CMV-MVA Triplex Vaccine) for the Enhancement of CMV-Specific Immunity and the Prevention of CMV Viremia in Pa · Phase 1 · recruiting
NCT06782542 — Olutasidenib, Venetoclax, and Azacitidine in IDH1 Mutated Newly Diagnosed Acute Myeloid Leukemia Patients Eligible for I · Phase 2 · recruiting
NCT07177079 — High-dose Ascorbate (HDA) in Combination With Standard of Care Azacitidine and Venetoclax in Acute Myeloid Leukemia (AML · Phase 1 · recruiting
NCT07384715 — First-in-human (FIH) Trial of GEN3018 in Relapsed or Refractory (R/R) Acute Myeloid Leukemia (AML) or Higher-risk Myelod · Phase 1 · recruiting
NCT07107126 — Safety and Proof-of-Concept Study of RPT1G in Adults With Acute Myeloid Leukemia and High-Risk Myelodysplastic Syndromes · Phase 1 · 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 NCT01211457 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 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: 16 July 2019

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/NCT01211457.

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