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Pediatric-Inspired Chemotherapy Plus Tyrosine Kinase Inhibitor in Adult Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia | Clinical Trials | Clareo Health

WITHDRAWNPHASE2

Pediatric-Inspired Chemotherapy Plus Tyrosine Kinase Inhibitor in Adult Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia

A Phase II Study Using a BFM Regimen Plus Tyrosine Kinase Inhibitor in Adult Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia

NCT04845035•University of Michigan Rogel Cancer Center

View on ClinicalTrials.gov

Summary

This study will combine a standard, pediatric-inspired, chemotherapy regimen with the tyrosine kinase inhibitors (TKIs) Dasatinib and Ponatinib to treat adults with Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia. There are two age groups/cohorts: * participants aged 18 to 59 years * participants aged 60 years and older One tyrosine kinase inhibitor (TKI), either Dasatinib or Ponatinib, will be administered in each of the respective chemotherapy cycles. The TKI (either Dasatinib or Ponatinib) administered in a given cycle of chemotherapy will be dictated by the given cycle's standard chemotherapy, in order to minimize overlapping side effects of the chemotherapy and TKI. The dosages of the standard chemotherapy agents, as well as the tyrosine kinase inhibitors (TKIs)--Dasatinib and Ponatinib--have been adjusted for each age group to allow continuous administration of these TKIs.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients ≥ 18 years of age.
•Baseline ECOG Performance Status ≤ 2, and patient is a candidate for intensive chemotherapy.
•Newly diagnosed Ph+ ALL.
•Written informed consent prior to any screening procedures. Permitted exceptions are that the diagnostic marrow exam/peripheral blood/nodal biopsy tests confirming Ph+ B-Cell ALL, as well as pre-induction cardiac workup (EKG/TTE/MUGA), may be performed prior to the patient providing written informed consent if these tests are within 14 days of enrollment.
•Patient able to give informed consent.
•B-cell Acute Lymphoblastic Leukemia with BCR-ABL1, i.e., Philadelphia chromosome-positive (Ph+) ALL.
•* B-Cell lineage determined by standard flow cytometry/IHC
•* Ph+ by cytogenetics (karyotype/FISH) and/or molecular (BCR-ABL1 transcripts)
•* Determined in CLIA-certified laboratory
•Previously untreated, except for below allowances in a recent diagnosis and up until 48 hours after starting trial therapy:
+3 more criteria

Exclusion Criteria

•Any of the following subtypes of ALL:
•* Ph-negative B-Cell ALL.
•* T-Cell ALL.
•* Relapsed Ph+ ALL.
•* Lymphoid blast crisis of chronic myeloid leukemia (CML).
•* Mature B-Cell (Burkitt's) ALL.
•Clinical signs of CNS disease.
•Active ALL in CNS or testes.
•Estimated Glomerular Filtration Rate (eGFR) by MDRD formula and calculated creatinine clearance (CrCl), based on a 24-hour urine collection, \< 30 mL/min-unless related to ALL/tumor lysis syndrome and able to be corrected.
•Total Bilirubin \> 2x ULN; AST/ALT \> 10x ULN, unless related to ALL liver infiltration.
+20 more criteria

Locations (1)

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, United States

Key Dates

Start Date

January 1, 2024

Primary Completion Date

January 1, 2026

Completion Date

January 1, 2029

Last Updated

February 22, 2024

Conditions

Acute Lymphoblastic Leukemia

Interventions

Dasatinib

DRUG

Ponatinib

DRUG

Berlin-Frankfurt-Münster Chemotherapy

DRUG

Methotrexate and Cytarabine

DRUG

Study of Venetoclax Combined With Azacitidine Regimen in Newly Diagnosed T-ALL Patients

NCT05376111

T-cell Acute Lymphoblastic LeukemiaRecruiting

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RECRUITINGPHASE1/PHASE2

A Study of Revumenib in R/R Leukemias Including Those With an MLL/KMT2A Gene Rearrangement or NPM1 Mutation

NCT04065399

Acute Myeloid LeukemiaAcute Lymphoblastic Leukemia+3 more

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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: February 22, 2024Data 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.

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Pediatric-Inspired Chemotherapy Plus Tyrosine Kinase Inhibitor in Adult Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia

Inclusion Criteria

Exclusion Criteria

Study of Venetoclax Combined With Azacitidine Regimen in Newly Diagnosed T-ALL Patients

A Study of Revumenib in R/R Leukemias Including Those With an MLL/KMT2A Gene Rearrangement or NPM1 Mutation

Chemotherapy (DA-EPOCH+/-R) and Targeted Therapy (Tafasitamab) for the Treatment of Newly-Diagnosed Philadelphia Chromosome Negative B Acute Lymphoblastic Leukemia

A Study of 14C-Bleximenib (Radiolabeled) in Participants With Acute Leukemia

CD19/CD22 Bicistronic Chimeric Antigen Receptor (CAR) T Cells in Children and Young Adults With Recurrent or Refractory CD19/CD22-expressing B Cell Malignancies

Venetoclax Basket Trial for High Risk Hematologic Malignancies