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NCT01081431: MDS-LE-MON-5
Safety of Lenalidomide and Markers for Disease Progression in Patients With International Prognostic Scoring System (IPSS) Low- or Intermediate-1 Risk Myelodysplastic Syndromes (MDS) With Isolated del5q
Phase 2 trial testing Lenalidomide in Myelodysplastic Syndromes in 91 participants. Completed in 24 May 2018.
24 May 2018
Quick facts
| Lead sponsor | Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 91 |
| Start date | 26 March 2010 |
| Primary completion | 24 May 2018 |
| Estimated completion | 24 May 2018 |
| Sites | 12 locations across Germany |
Drugs / interventions tested
- Lenalidomide — full drug profile →
Conditions studied
- Myelodysplastic Syndromes — all drugs for Myelodysplastic Syndromes →
Sponsor
Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH — full company profile →
Who can join
18 and older, any sex, with Myelodysplastic Syndromes. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this study is to determine the safety of lenalidomide and markers for disease progression in the treatment of IPSS low- or intermediate-1 risk MDS with isolated del5q.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Telomere dynamics in patients with del (5q) MDS before and under treatment with lenalidomide.
Beier F, Masouleh BK, Buesche G, Ventura Ferreira MS, et al · · 2015 · cited 15× · PMID 26427727 · DOI 10.1016/j.leukres.2015.09.003 -
Genome-wide DNA methylation analysis pre- and post-lenalidomide treatment in patients with myelodysplastic syndrome with isolated deletion (5q).
Hecht A, Meyer JA, Jann JC, Sockel K, et al · · 2021 · PMID 33903952 · DOI 10.1007/s00277-021-04492-1
Verify or expand the search:
- PubMed search for NCT01081431
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Currently open trials in the same condition.
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Other Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH trials
Trials by the same sponsor.
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- NCT01320111 — Breast Cancer Study: Paclitaxel Versus Paclitaxel Plus Sorafenib in Second- or Third-line Treatment · Phase 2 · completed
- NCT01090089 — Combination of Lenalidomide and Dexamethasone in Treatment of Multiple Myeloma · Phase 3 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01081431 (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 Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH
- Last refreshed: 23 February 2024
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/NCT01081431.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing