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Anti-metabolites

Drug Combination for Pediatric Acute Leukemia

Phase 1

Waitlist Available

Led By Branko Cuglievan, MD

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adequate renal function (creatinine clearance ≥ 30 mL/min unless related to disease)

Age must be between 1 year to 21 years

Must not have

Participants with an active uncontrolled infection

Participants who weigh less than 10kg

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion; an average of 1 year

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to determine the right amount of a drug combination for patients with relapsed or refractory types of leukemia."

Who is the study for?

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.

What is being tested?

The study aims to find the right dose for a drug combo (cladribine, cytarabine, decitabine, sorafenib) in young patients with certain relapsed/refractory acute leukemias.

What are the potential side effects?

Potential side effects aren't listed here but may include typical reactions to chemotherapy such as nausea, fatigue, increased infection risk and liver issues due to the nature of these drugs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My kidneys work well enough (creatinine clearance ≥ 30 mL/min).

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I am between 1 and 21 years old.

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My physical activity is limited due to my health condition.

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My leukemia has returned or is not responding to treatment, with specific test results confirming it.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I currently have an infection that isn't under control.

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I weigh less than 10kg.

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I do not have severe stomach or metabolic issues affecting medication absorption.

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I am currently being treated for another cancer.

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I have an active hepatitis B, hepatitis C, or HIV infection.

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I am currently pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion; an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion; an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion; an average of 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Safety and adverse events (AEs)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Decitabine

2004

Completed Phase 3

~1680

Cytarabine

2016

Completed Phase 3

~3330