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A Phase I Study Investigating the Combination of Cladribine, Low Dose Cytarabine and Sorafenib Alternating With Decitabine in Pediatric Relapsed and Refractory Acute Leukemias | Clinical Trials | Clareo Health

WITHDRAWNPHASE1

A Phase I Study Investigating the Combination of Cladribine, Low Dose Cytarabine and Sorafenib Alternating With Decitabine in Pediatric Relapsed and Refractory Acute Leukemias

NCT06474663•M.D. Anderson Cancer Center

View on ClinicalTrials.gov

Summary

To find the recommended dose of the drug combination cladribine, cytarabine, decitabine, and sorafenib in participants with relapsed/refractory AML, MPAL, and ALAL.

Detailed Description

Primary Objectives - To determine the safety, tolerability, and recommended phase II dose (RP2D) of the combination of cladribine, low-dose cytarabine, sorafeneib alternating with decitabine for pediatric participants with acute leukemias. Secondary Objectives \- To determine the preliminary assessment of efficacy by overall response (OR), including complete remission (CR), CR with partial hematological recovery (CRh), CR with incomplete blood count recovery (CRi), Morphologic leukemia free state (MLFS) and partial remission (PR), overall survival (OS), event-free survival (EFS) and duration of response (DOR) of pediatric participants treated with this combination.

Eligibility

Age

1 - 21 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age ≥ 1 year to 21 years
•2. ECOG performance status of ≥ 2.
•3. Relapsed21/refractory: AML22 or Mixed phenotype acute leukemia (MPAL) patients /Acute leukemia of ambiguous lineage (ALAL) with.
•1. ≥1% leukemic blasts in the bone marrow:
•2. As detected by MRD testing ≥ 25% or MRD is ≥ 5% with 1 additional sensitive diagnostic test demonstrating .1% blasts (NGS-MRD (clonoSeq23) or FISH or cytogenetics or RT-PCR of leukemic specific marker or M2/M3 morphology); or MRD is ≥ 1% with 2 additional sensitive diagnostic tests demonstrating ≥1% blasts.
•i. If the MRD is ≥ 1% but without the required confirmatory tests, then a relapse can still be defined if a consecutive marrow evaluation separated by ≥1 week demonstrates. ≥ 1% using 2 sensitive diagnostic tests.
•ii. If MRD testing is unavailable, then a single marrow is sufficient to define relapse if M3 morphology or M2 morphology with 1 additional sensitive diagnostic test demonstrating ≥1% blasts (FISH or cytogenetics or RT-PCR of leukemic specific marker) or M1 morphology with 2 additional sensitive diagnostic tests demonstrating. ≥1% blasts is present.
•iii. If the morphology is M2 with no confirmatory tests, then a relapse can still be defined if a consecutive marrow evaluation separated by ≥ 1 week demonstrates M2 morphology.
•c. Marrow definitions: M2 marrow ≥ 5 to \<25% blasts; M3 marrow ≥ 25% blasts
•4. WBC must be below 25,000/ ƒÊL at time of enrollment. Patients may receive cytoreduction prior to enrollment.
+5 more criteria

Exclusion Criteria

•1. Participants who weigh less than 10kg.
•2. Participants with any concurrent uncontrolled medical condition, laboratory abnormality, or psychiatric illness which could place the participant at unacceptable risk of study treatment.
•3. The use of other chemotherapeutic agents or anti-leukemic agents is not permitted during study with the following exceptions (1) intrathecal chemotherapy for prophylactic use or for controlled CNS leukemia. (2) use of hydroxyurea for patients with rapidly proliferative disease or for control of counts during differentiation syndrome. (3) use of steroids for treatment of differentiation syndrome.
•4. Participants with any severe gastrointestinal or metabolic condition which could interfere with the absorption of oral study medications.
•5. Participants with a concurrent active malignancy under treatment.
•6. Known active hepatitis B (HBV) or Hepatitis C (HCV) infection or known HIV infection.
•7. Female participants who are pregnant or breast-feeding.
•8. Participants has an active uncontrolled infection.
•9. 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.

Key Dates

Start Date

July 31, 2025

Primary Completion Date

July 31, 2025

Completion Date

July 31, 2025

Last Updated

August 6, 2025

Conditions

Refractory Acute LeukemiaRelapsed Acute Leukemia

Interventions

Cladribine

DRUG

Cytarabine

DRUG

Sorafenib

DRUG

Decitabine

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 6, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Phase I Study Investigating the Combination of Cladribine, Low Dose Cytarabine and Sorafenib Alternating With Decitabine in Pediatric Relapsed and Refractory Acute Leukemias

Inclusion Criteria

Exclusion Criteria

Study of Selinexor and Venetoclax in Combination With Chemotherapy in Pediatric and Young Adult Patients With Refractory or Relapsed Acute Myeloid Leukemia

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