Clinical trial · Interventional
Lenalidomide in Treating Older Patients With Acute Myeloid Leukemia
A Phase II Study of Lenalidomide (REVLIMID, NSC-703813) for Previously Untreated Non-M3, Deletion 5q Acute Myeloid Leukemia (AML) in Patients Age 60 or Older Who Decline Remission Induction Chemotherapy
NCT00352365CI-TRIAL-00056487completedPhase 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)
This phase II trial is studying how well lenalidomide works in treating older patients with acute myeloid leukemia with abnormal chromosome 5q. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing.
Conditions
Conditions (17)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adult Acute Basophilic Leukemia | Adult Acute Basophilic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Adult Acute Eosinophilic Leukemia | — | UNRESOLVED | — |
| Adult Acute Megakaryoblastic Leukemia (M7) | Adult Acute Megakaryoblastic Leukemia | ONTOLOGY_EXACT | 0.85 |
| Adult Acute Minimally Differentiated Myeloid Leukemia (M0) | Adult Acute Myeloid Leukemia with Minimal Differentiation | ALIAS | 0.90 |
| Adult Acute Monoblastic Leukemia (M5a) | Adult Acute Monoblastic Leukemia | ONTOLOGY_EXACT | 0.85 |
| Adult Acute Monocytic Leukemia (M5b) | Adult Acute Monocytic Leukemia | ONTOLOGY_EXACT | 0.85 |
| Adult Acute Myeloblastic Leukemia With Maturation (M2) | Adult Acute Myeloid Leukemia with Maturation | ALIAS | 0.90 |
| Adult Acute Myeloblastic Leukemia Without Maturation (M1) |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| lenalidomide | Drug | Lenalidomide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (lenalidomide)
- description
- INDUCTION THERAPY: Patients receive oral lenalidomide once daily on days 1-14, 1-21, or 1-28 (course 1). Patients undergo bone marrow biopsy on day 28 or 35 to assess treatment efficacy. Patients with stable or improving disease (i.e., a decrease in blast percentage) without progressive disease proceed to maintenance therapy. MAINTENANCE THERAPY: Beginning within 42 days after completion of induction therapy, patients receive oral lenalidomide once daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: lenalidomide
Primary outcomes (1)
- measure
- Complete Response
- timeFrame
- Up to 5 years
- description
- Morphologic complete remission (CR): ANC \>=1,000/mcl, platelet count \>=100,000/mcl, \<5% bone marrow blasts, no Auer rods, no evidence of extramedullary disease. Morphologic complete remission with incomplete blood count recovery (CRi): Same as CR but ANC may be \<1,000/mcl and/or platelet count \<100,000/mcl.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * Morphologically confirmed diagnosis of acute myeloid leukemia (AML) by bone marrow aspiration and biopsy within the past 14 days * Diagnostic biopsy within the past 28 days with marrow blast percentage ≥ 70% allowed provided no potentially antileukemic therapy was received after biopsy * Cytogenetic evidence of del (5q) abnormality by conventional karyotyping or fluorescence in situ hybridization (FISH) * Previously untreated disease * Must have declined standard AML cytotoxic chemotherapy regimens * WBC ≤ 30,000/mm³ * History of prior myelodysplastic syndromes (MDS) allowed * No acute promyelocytic leukemia (FAB M3) * No blastic transformation of chronic myelogenous leukemia * Zubrod performance status 0-2 * Bilirubin ≤ 2.5 times upper limit of normal (ULN) (unless elevation is due primarily to elevated unconjugated hyperbilirubinemia secondary to Gilbert's syndrome or hemolysis, but not to liver dysfunction) * AST and ALT ≤ 3.5 times ULN * Creatinine ≤ 1.5 times ULN * HIV negative * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use 2 forms of effective contraception at least 4 weeks prior to, during, and for 4 weeks after completion of study treatment * No known allergy to thalidomide * Concurrent enrollment on SWOG-S9910 allowed (for SWOG patients) * No prior systemic chemotherapy for acute leukemia except hydroxyurea * Single-dose intrathecal chemotherapy allowed before or concurrently with induction chemotherapy * No prior AML induction-type chemotherapy or high-dose chemotherapy with hematopoietic stem cell support * Prior hematopoietic growth factors, thalidomide, arsenic trioxide, signal-transduction inhibitors, azacitidine, and low-dose cytarabine (i.e., \< 100 mg/m²/day) for treatment of MDS allowed * At least 30 days since prior therapy for MDS (excluding growth factors) * No prior lenalidomide for MDS * At least 6 months since prior chemotherapy or radiotherapy for another malignancy * No concurrent therapy for another malignancy * Concurrent hormonal therapy allowed
References
Publications (1)
- DERIVEDSekeres MA, Gundacker H, Lancet J, Advani A, Petersdorf S, Liesveld J, Mulford D, Norwood T, Willman CL, Appelbaum FR, List AF. A phase 2 study of lenalidomide monotherapy in patients with deletion 5q acute myeloid leukemia: Southwest Oncology Group Study S0605. Blood. 2011 Jul 21;118(3):523-8. doi: 10.1182/blood-2011-02-337303. Epub 2011 May 6. PMID 21551228