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Trial Title: Identification of Necessary Information for Treatment Induction in Newly Diagnosed Acute Lymphoblastic Leukemia/Lymphoma

NCT ID: NCT06289673

Condition: Acute Lymphoblastic Leukemia
Lymphoblastic Lymphoma
Mixed Phenotype Acute Leukemia

Conditions: Official terms:
Lymphoma
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Cytarabine
Dexamethasone
Hydrocortisone
Methotrexate
Vincristine
Daunorubicin

Conditions: Keywords:
Newly Diagnosed
Risk Category
Acute Lymphoblastic Leukemia
Lymphoblastic Lymphoma
Mixed Phenotype Acute Leukemia (MPAL)
Children
Young Adults

Study type: Interventional

Study phase: Phase 4

Overall status: Not yet recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Dexamethasone
Description: Per mouth (PO) or intravenously (IV) once on Day 1 and PO or IV divided BID (every 12 hours) days 2-7
Arm group label: Newly diagnosed ALL, LLy, and MPAL patients

Other name: Decadron

Intervention type: Drug
Intervention name: Vincristine
Description: Intravenously (IV) for 1 dose on Day 1 or 2
Arm group label: Newly diagnosed ALL, LLy, and MPAL patients

Other name: Vincristine Sulfate

Other name: Oncovin

Intervention type: Drug
Intervention name: Daunorubicin
Description: Intravenously (IV) for 1 dose on Day 2 or 3 (T-ALL/ T-LLy/ MPAL only)
Arm group label: Newly diagnosed ALL, LLy, and MPAL patients

Other name: Daunomycin

Intervention type: Drug
Intervention name: Intrathecal triple therapy (methotrexate + hydrocortisone + cytarabine)
Description: Intrathecal (Age adjusted) for 1 dose on Day 4 or 5 or 6
Arm group label: Newly diagnosed ALL, LLy, and MPAL patients

Other name: ITMHA

Intervention type: Drug
Intervention name: Methotrexate
Description: Given IT as part of Intrathecal triple therapy.
Arm group label: Newly diagnosed ALL, LLy, and MPAL patients

Other name: MTX

Other name: Trexall®

Intervention type: Drug
Intervention name: Cytarabine
Description: Given IT as part of Intrathecal triple therapy.
Arm group label: Newly diagnosed ALL, LLy, and MPAL patients

Other name: Cytosine arabinoside

Other name: Ara-C

Summary: The goal of this study is to provide sufficient therapy during the time a patients' B-cell Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Leukemia (LLy) risk category is being determined. The term "risk" refers to the chance of the ALL or LLy coming back after treatment. Primary Objectives - To provide sufficient therapy to enable testing of newly diagnosed acute lymphoblastic leukemia/lymphoma and mixed phenotype acute leukemia/lymphoma tumor samples to determine eligibility and appropriate risk stratification for SJALL therapeutic studies. - To develop a central database of genomic and clinical findings. Secondary Objectives - To assess event free and overall survival data of patients enrolled on this study.

Detailed description: Patients with newly diagnosed acute lymphoblastic leukemia/ lymphoma (ALL/LLy) and mixed phenotype acute leukemia/ lymphoma (MPAL) will undergo diagnostic procedures either during screening or on Day 1. They will receive 7 days of chemotherapy including 13 doses of dexamethasone, 1 dose of vincristine, and 1 dose of daunorubicin (for patients with T-ALL/LLy or MPAL only). Patients will also undergo their initial lumbar puncture with intrathecal chemotherapy on Days 4 or 5 or 6 of therapy. After the completion of 7 days of chemotherapy, patients will begin therapy on either a SJALL therapeutic trial or will receive non-protocol therapy.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - Age 1-18.99 years - Diagnosis of acute leukemia / lymphoma as below: - Acute lymphoblastic leukemia (ALL) with at least 25% bone marrow blasts or definitive evidence of ALL in peripheral blood (in those without an available bone marrow sample). - Lymphoblastic lymphoma (LLy) with immunophenotypic evidence of a lymphoblastic population and <25% bone marrow blasts and less than 1,000 circulating blasts/ microL. - Mixed phenotype acute leukemia (MPAL) with or without 25% bone marrow involvement (i.e. patients with either leukemia or lymphoma are eligible). Exclusion Criteria: - Pregnant or breastfeeding - Receipt of prior cancer directed therapy with the exclusion of up to 1 dose of intrathecal chemotherapy, 1 dose of vincristine, or emergency radiotherapy due to organ compromising malignant mass. There is no exclusion for prior steroid therapy. - Known to be currently ineligible for available SJALL therapeutic studies (e.g. receipt of prohibited therapy, no appropriate SJALL therapeutic study available, enrolled on competing trial, etc.). Note: the intention of this exclusion criterion is to only enroll participants who may subsequently enroll on an SJALL therapeutic trial. If participant is screened as a potential participant for subsequent SJALL and later found to be ineligible due to information obtained during INITIALL, this will not make the participant ineligible for INITIALL. - Inability or unwillingness of research participant or legal guardian/representative to give written informed consent. - Major pre-existing abnormalities such as ataxia telangiectasia, Fanconi anemia, Charcot Marie Tooth, etc.

Gender: All

Minimum age: 1 Year

Maximum age: 18 Years

Healthy volunteers: No

Locations:

Facility:
Name: United States, Tennessee St. Jude Children's Research Hospital

Address:
City: Memphis
Zip: 38105
Country: United States

Contact:
Last name: Seth E. Karol, MD

Phone: 866-278-5833
Email: referralinfo@stjude.org

Investigator:
Last name: Seth E. Karol, MD
Email: Principal Investigator

Start date: December 2024

Completion date: May 2039

Lead sponsor:
Agency: St. Jude Children's Research Hospital
Agency class: Other

Source: St. Jude Children's Research Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06289673
http://www.stjude.org
http://www.stjude.org/protocols

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