Phase 2
N=41
Lenalidomide in Treating Older Patients With Acute Myeloid Leukemia
Adult Acute Basophilic Leukemia · Adult Acute Eosinophilic Leukemia · Adult Acute Megakaryoblastic Leukemia (M7) · Adult Acute Minimally Differentiated Myeloid Leukemia (M0) · Adult Acute Monoblastic Leukemia (M5a)
Bottom Line
View on ClinicalTrials.gov: NCT00352365 ↗Enrolled (actual)
41
Serious AEs
62.2%
Results posted
Jul 2013
Primary outcome: Primary: Complete Response — 11 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- lenalidomide (Drug)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- All
- Sponsor
- National Cancer Institute (NCI)
- Primary completion
- Jul 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Complete Response |
11 | — |
| SECONDARY Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug |
1; 0; 1; 0; 1; 0 | — |
| SECONDARY Cytogenetic Abnormalities |
8; 8 | — |
| SECONDARY Total Response |
14 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00352365). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.