Trial Summary
What is the purpose of this trial?
To find the recommended dose of the drug combination cladribine, cytarabine, decitabine, and sorafenib in participants with relapsed/refractory AML, MPAL, and ALAL.
Research Team
Branko Cuglievan
Principal Investigator
M.D. Anderson Cancer Center
Eligibility Criteria
This trial is for children with acute leukemias that have come back or didn't respond to previous treatments. The specific types of leukemia are AML, MPAL, and ALAL. Details on who can join are not provided here.Inclusion Criteria
My liver is functioning well, according to recent tests.
It has been over 14 days since my last cancer treatment, or 5 half-lives of the treatment.
My kidneys work well enough (creatinine clearance ≥ 30 mL/min).
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Exclusion Criteria
I currently have an infection that isn't under control.
History of or any concurrent condition, therapy, or laboratory abnormality that in the Investigator's opinion might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the participants
I do not have any uncontrolled conditions that could make the study unsafe for me.
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Treatment Details
Interventions
- Cladribine (Anti-metabolites)
- Cytarabine (Anti-metabolites)
- Decitabine (Anti-metabolites)
- Sorafenib (Kinase Inhibitor)
Trial OverviewThe study aims to find the right dose for a drug combo (cladribine, cytarabine, decitabine, sorafenib) in young patients with certain relapsed/refractory acute leukemias.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Phase 1Experimental Treatment4 Interventions
Participants enrolled in Phase 1, the dose level of cladribine, cytarabine, decitabine, and sorafenib will depend on when you join this study. Up to 2 dose levels of this drug combination may be tested. Between 3-6 participants will be enrolled in each dose level. The first group of participants will receive the starting dose level of this drug combination. If no intolerable side effects are seen, the next group of participants will receive the higher dose level of this drug combination.
Group II: Dose ExpansionExperimental Treatment4 Interventions
Participants enrolled in Dose Expansion, you will receive cladribine, cytarabine, decitabine, and sorafenib at the recommended dose level found in Phase 1.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
MD Anderson Cancer CenterHouston, TX
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Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor
Trials
3107
Patients Recruited
1,813,000+