At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed AML at original diagnosis
- ✓Relapsed disease with >=5% blasts in bone marrow (M2/M3) or absolute blast count >1000/μL in peripheral blood
- ✓First marrow relapse without prior re-induction therapy (for efficacy phase)
- ✓Refractory or treatment-naive secondary AML with <=1 prior induction attempt allowed
- ✕Acute promyelocytic leukemia (APL)
- ✕Down syndrome or hereditary bone marrow failure syndromes (Fanconi anemia, Kostmann syndrome, Shwachman syndrome)
- ✕Wilson's disease or other copper metabolism disorder
- ✕Juvenile myelomonocytic leukemia (JMML)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1/2 Study of CPX-351 (NSC# 775341) Alone Followed by Fludarabine, Cytarabine, and G-CSF (FLAG) for Children With Relapsed Acute Myeloid Leukemia (AML)
In Brief
A Phase 2 clinical trial evaluating Cytarabine, Filgrastim, and 4 other interventions for Acute Myeloid Leukemia Post Cytotoxic Therapy and 2 related conditions. Completed, enrolled 38 participants across 73 sites in 2 countries.
Detailed Summary
This phase I/II trial studies the side effects and best dose of liposome-encapsulated daunorubicin-cytarabine when given with fludarabine phosphate, cytarabine, and filgrastim and to see how well they work in treating younger patients with acute myeloid leukemia that has come back after treatment (relapsed) or is not responding to treatment (is refractory). Liposome-encapsulated daunorubicin-cytarabine is made up of two chemotherapy drugs, cytarabine and daunorubicin hydrochloride, and works to stop cancer cell growth by blocking the cells from dividing. Drugs used in chemotherapy, such as fludarabine phosphate and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Filgrastim may increase the production of blood cells and may help the immune system recover from the side effects of chemotherapy. Giving liposome-encapsulated daunorubicin-cytarabine followed by fludarabine phosphate, cytarabine, and filgrastim may be a better treatment for patients with relapsed acute myeloid leukemia and may cause fewer side effects to the heart, a common effect of other chemotherapy treatments for acute myeloid leukemia.
Study Details
Timeline
Interventions
Given IT or IV
Given SC or IV
Given IV
Correlative studies
Given IV
Correlative studies