Leukemia, Acute Myelogenous Clinical Trial
Official title:
A Phase I Study of Combination Chemotherapy With Mitoxantrone and Etoposide (VP-16) Combined With an Autophagy Inhibitor, Hydroxychloroquine (HCQ), for the Treatment of Patients With Relapsed Acute Myelogenous Leukemia (AML)
This is an open label phase I clinical trial of hydroxychloroquine (HCQ) ,when it is combined with the usual medications for acute myeloid leukemia, mitoxantrone and etoposide. The purpose of this study is to find the safest and most effective dose of hydroxychloroquine with these medications. The investigators will be testing to see if it can increase the effectiveness of mitoxantrone and etoposide.
Hydroxychloroquine is not FDA (United States Food and Drug Administration) approved for AML
and is considered an investigational drug in this study. It has helped make chemotherapy more
effective in animals. The investigators will be testing to see if it can increase the
effectiveness of mitoxantrone and etoposide. It has been combined with other types of
chemotherapy for humans with other types of cancer. Most of the patients were able to take
hydroxychloroquine safely at the doses studied in this clinical trial.
Hydroxychloroquine is approved by the FDA for malaria, rheumatoid arthritis, and other
autoimmune diseases. Mitoxantrone is approved by the FDA for use in AML, and it is one of the
most common drugs used in the treatment of AML. Etoposide is not approved by the FDA for AML.
It is approved for small cell lung cancer and testicular cancer. It is commonly used in AML.
The primary objective of this trial is to determine the recommend phase 2 dose (RP2D) for HCQ
combined with mitoxantrone and etoposide, while secondary objectives include efficacy
estimates of this combination at the RP2D, a safety and tolerability profile of this
combination, as well as the correlation of pharmacodynamic assessments of autophagy
inhibition with dose and clinical response.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT02665065 -
Study of Iomab-B vs. Conventional Care in Older Subjects With Active, Relapsed or Refractory Acute Myeloid Leukemia
|
Phase 3 |