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NCT01246622
Lenalidomide and Cytarabine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia
Phase 1 trial testing cytarabine in Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities in 32 participants. Completed in 5 June 2019.
15 May 2014
Quick facts
| Lead sponsor | Roswell Park Cancer Institute |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 32 |
| Start date | 7 February 2011 |
| Primary completion | 15 May 2014 |
| Estimated completion | 5 June 2019 |
| Sites | 1 location across United States |
Drugs / interventions tested
- cytarabine — full drug profile →
- lenalidomide — full drug profile →
Conditions studied
- Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities — all drugs for Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities →
- Adult Acute Myeloid Leukemia With Del(5q) — all drugs for Adult Acute Myeloid Leukemia With Del(5q) →
- Adult Acute Myeloid Leukemia With Inv(16)(p13;q22) — all drugs for Adult Acute Myeloid Leukemia With Inv(16)(p13;q22) →
- Adult Acute Myeloid Leukemia With t(15;17)(q22;q12) — all drugs for Adult Acute Myeloid Leukemia With t(15;17)(q22;q12) →
Sponsor
Roswell Park Cancer Institute
Who can join
18 and older, any sex, with Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities or Adult Acute Myeloid Leukemia With Del(5q). Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This phase I trial is studying the side effects and best dose of lenalidomide when given together with cytarabine in treating patients with relapsed or refractory acute myeloid leukemia (AML). Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving lenalidomide together with cytarabine may kill more cancer cells
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Current Approaches in the Treatment of Relapsed and Refractory Acute Myeloid Leukemia.
Ramos NR, Mo CC, Karp JE, Hourigan CS. · · 2015 · cited 91× · PMID 25932335 · DOI 10.3390/jcm4040665
Verify or expand the search:
- PubMed search for NCT01246622
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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- NCT06744504 — Standard-dose vs Intermediate-dose Cytarabine Induction in the Treatment of Acute Myeloid Leukemia With RUNX1-RUNX1T1 · Phase 3 · recruiting
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- NCT05712278 — A Study to Investigate Use of Off-the-shelf Natural Killer (NK) Cells (SAR445419) in Relapsed/Refractory Acute Myeloid L · Phase 1 · terminated
Other recruiting trials for Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
Currently open trials in the same condition.
- NCT02094794 — Total Marrow and Lymphoid Irradiation and Chemotherapy Before DSCT in Treating Patients With High-Risk ALL or AML · Phase 2 · active not recruiting
Other Roswell Park Cancer Institute trials
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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 NCT01246622 (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 Roswell Park Cancer Institute
- Last refreshed: 24 September 2020
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/NCT01246622.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing