Clinical trial · Interventional
A Study Being Conducted at Multiple Locations to Compare Safety and Efficacy of Three Different Regimens; (1) High-Dose Lenalidomide; (2) Lenalidomide + Azacitidine; or (3) Azacitidine in Subjects ≥ 65 Years With Newly-Diagnosed Acute Myeloid Leukemia
A Phase 2, Multicenter, Randomized, Open-label, Parallel-group Study of a Lenalidomide (Revlimid®) Regimen or a Sequential Azacitidine (Vidaza®) Plus Lenalidomide (Revlimid®) Regimen Versus an Azacitidine (Vidaza®) Regimen for Therapy of Older Subjects With Newly Diagnosed Acute Myeloid Leukemia
NCT01358734CI-TRIAL-00039199completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The study aim is to compare safety and efficacy of high-dose lenalidomide regimen, sequential azacitidine and lenalidomide and an azacitidine in persons ≥65 years with newly-diagnosed acute myeloid leukemia (AML).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myelogenous Leukemia | Acute Myeloid Leukemia | ALIAS | 0.90 |
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Azacitidine | Drug | Azacitidine | ALIAS |
| Best Supportive Care (BSC) | Other | — | UNRESOLVED |
| Lenalidomide | Drug | Lenalidomide | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Lenalidomide in combination with azacitidine
- description
- Repeated cycles of azacitidine 75 mg/m\^2/day subcutaneous (SC) on Days 1-7 and lenalidomide 50 mg/day by mouth (PO) on Days 8-28 followed by a 14-day break plus best supportive care
- interventionNames
- Drug: Azacitidine
- Drug: Lenalidomide
- Other: Best Supportive Care (BSC)
- type
- EXPERIMENTAL
- label
- Lenalidomide - single agent
- description
- Lenalidomide 50 mg PO daily for 28 days for the first 2 cycles and lenalidomide 25 mg daily for 28 days for the next 2 cycles followed by continuous 28-day cycles of lenalidomide 10 mg daily PO plus best supportive care
- interventionNames
- Drug: Lenalidomide
- Other: Best Supportive Care (BSC)
- type
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Newly diagnosed acute myeloid leukemia (AML), AML with antecedent hematologic disorder or therapy-related AML * Male or female subjects aged ≥ 65 * Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 * White blood cell (WBC) count ≤ 10 x 10⁹/L at screening Exclusion Criteria: * Previous treatment with azacitidine, decitabine, cytarabine or lenalidomide * Previous cytotoxic or biologic treatment of any kind for AML or prior use of targeted therapy agents. * Suspected or proven acute promyelocytic leukemia * Prior bone marrow or stem cell transplantation * Candidate for allogeneic bone marrow or stem cell transplantation * AML antecedent hematologic disorder such as chronic myelogenous leukemia or myeloproliferative neoplasms * Presence of malignant disease within the previous 12 months with exceptions
References
Publications (1)
- DERIVEDMedeiros BC, McCaul K, Kambhampati S, Pollyea DA, Kumar R, Silverman LR, Kew A, Saini L, Beach CL, Vij R, Wang X, Zhong J, Gale RP. Randomized study of continuous high-dose lenalidomide, sequential azacitidine and lenalidomide, or azacitidine in persons 65 years and over with newly-diagnosed acute myeloid leukemia. Haematologica. 2018 Jan;103(1):101-106. doi: 10.3324/haematol.2017.172353. Epub 2017 Nov 2. PMID 29097499