Clinical trial · Interventional
Lenalidomide Plus Chemotherapy for AML
A Phase I Study of Lenalidomide Plus Chemotherapy With Mitoxantrone, Etoposide, and Cytarabine for the Reinduction of Patients With Acute Myelogenous Leukemia
- 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 research study is a Phase I clinical trial. Phase I clinical trials test the safety of an investigational combination of drugs. Phase I studies also try to define the appropriate dose of the investigational combination of drugs to use for further studies. "Investigational" means that the combination of drugs is still being studied and that research doctors are trying to find out more about it. It also means that the FDA has not approved this combination of drugs for AML. As part of this research study, you will take lenalidomide in combination with MEC. MEC are FDA approved chemotherapy drugs that are commonly used in the treatment of AML. Lenalidomide is approved by the FDA for patients with multiple myeloma, and some patients with myelodysplasia. Lenalidomide is considered investigational in this research study because it is not approved by the FDA for patients with AML. Lenalidomide is a drug that affects the immune system, called an immunomodulatory drug or IMID. This drug is successful in the treatment of patients with multiple myeloma and some patients with myelodysplasia, a pre-leukemic condition. Other research studies suggest that lenalidomide may also be effective in patients with AML. Since we know that many patients who receive MEC chemotherapy alone do not have a prolonged remission (time free from leukemia), we are studying the addition of lenalidomide to MEC. In this research study, we are looking for the highest dose of lenalidomide that can be given safely with MEC.
Conditions
Conditions (1)
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 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cytarabine | Drug | Cytarabine | ALIAS |
| Etoposide | Drug | Etoposide | ALIAS |
| Lenalidomide | Drug | Lenalidomide | ALIAS |
| Mitoxantrone | Drug | Mitoxantrone | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment Arm
- description
- Lenalidomide and re-induction chemotherapy
- interventionNames
- Drug: Lenalidomide
- Drug: Mitoxantrone
- Drug: Etoposide
- Drug: Cytarabine
Primary outcomes (1)
- measure
- Safety of lenalidomide plus conventional chemotherapy for relapsed AML
- timeFrame
- 2 years
- description
- Evaluation of the safety of lenalidomide in combination with conventional chemotherapy for relapsed acute myelogenous leukemia. Dose limiting toxicity is defined as a Grade IV rash or delayed neutrophil or platelet recovery beyond Day 45 after start of chemotherapy in the absence of disease
Secondary outcomes (4)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Primary refractory disease following at least one cycle of induction therapy or first relapse or higher * Must be registered into RevAssist program * Able and willing to adhere to study schedule and other protocol requirements Exclusion Criteria: * Pregnant or breastfeeding * Known hypersensitivity to thalidomide or lenalidomide * Known seropositive for HIV * Have had myocardial infarction within 6 months of enrollment or NYHA Class III or IV heart failure * Other serious medical conditions or psychiatric conditions * Major surgery within 28 days prior to treatment * Received investigational agent or cytotoxic chemotherapy (except hydroxyurea) within 2 weeks of study * Acute promyelocytic leukemia
References
Publications (0)
Data not yet available