Daunorubicin
DrugIn the event of a shortage of daunorubicin, doxorubicin may be used as a substitute.
NCT Number: NCT01920737
The purpose of the study is to find out whether the combination of chemotherapy drugs that are routinely used in children with ALL, will be safe and effective in treating adult patients with ALL. The standard treatment for adults with ALL consists of many chemotherapy drugs that are given in different combinations and in several steps. In adult ALL there is no standard which drugs to give and how to combine them. Some leukemias have a chromosome abnormality called Philadelphia chromosome (also called Ph Positive) and some leukemias do not (called Ph Negative). In this study we want to see whether this combination of chemotherapy drugs will be safe and effective in treating adult patients with Ph Negative ALL.
This study is active but is not currently recruiting participants.
Notify Me18 year–60 year
All sexes
Interventional
Phase 2
Memorial Sloan Kettering Cancer Center, New York, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
In the event of a shortage of daunorubicin, doxorubicin may be used as a substitute.
PET or CT scan every 6 months for 3 years
Time frame: 1 year
i.e. minimal residual disease (MRD) negative status, as assessed by PCR and flow cytometry in the bone marrow after phase I induction.
Time frame: 1 year
All three criteria must be met for clinical complete remission:
Time frame: 1 year
OS will be calculated from the start of induction therapy to death or last follow-up.
Time frame: 1 year
EFS survival will be calculated from the start of induction therapy to relapse (molecular or clinical), death, or last follow-up.
Time frame: 1 year
DFS will be calculated from the time of clinical CR (or better) to relapse (molecular or clinical), death, or last follow-up.
Time frame: 1 year
Molecular relapse is defined as the conversion of RT-PCR from MRD negative to MRD positive on two consecutive tests performed on bone marrow at least one week apart, while still meeting criteria for clinical CR.
Time frame: 1 year
Number of participants with adverse events. Frequencies of toxicities based on the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 4.0 will be tabulated.
Memorial Sloan Kettering Cancer Center
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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