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

Acute Lymphoblastic Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06289673
• Other study ID #: INITIALL
• Secondary ID: NCI-2024-01659
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: July 2024
• Est. completion date: May 2039

Study information

• Verified date: June 2024
• Source: St. Jude Children's Research Hospital
• Contact: Seth E. Karol, MD
• Phone: 866-278-5833
• Email: referralinfo[@]stjude.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 850
• Est. completion date: May 2039
• Est. primary completion date: May 2034
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia
• Leukemia
• Leukemia, Lymphoid
• Lymphoblastic Lymphoma
• Lymphoma
• Mixed Phenotype Acute Leukemia
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Drug:
• Dexamethasone
Per mouth (PO) or intravenously (IV) once on Day 1 and PO or IV divided BID (every 12 hours) days 2-7
• Vincristine
Intravenously (IV) for 1 dose on Day 1 or 2
• Daunorubicin
Intravenously (IV) for 1 dose on Day 2 or 3 (T-ALL/ T-LLy/ MPAL only)
• Intrathecal triple therapy (methotrexate + hydrocortisone + cytarabine)
Intrathecal (Age adjusted) for 1 dose on Day 4 or 5 or 6
• Methotrexate
Given IT as part of Intrathecal triple therapy.
• Cytarabine
Given IT as part of Intrathecal triple therapy.

Locations

Country	Name	City	State
United States	United States, Tennessee St. Jude Children's Research Hospital	Memphis	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
St. Jude Children's Research Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sufficient phenotypic and/or genomic data necessary for therapeutic protocol assignment by Day 8 (completion of INITIALL therapy).	The proportion of patients with sufficient immunophenotypic, genomic, and clinical data to allow determination of eligibility for currently open trials at the enrolling institution.	1 week from study entry
Primary	Complete data within the INITIALL database	The proportion of patients with complete data within the INITIALL protocol database as described in the protocol.	3 months, 1 year, 3, 5 years from study entry
Secondary	Event Free Survival (EFS)	EFS will be reported as estimates using the Kaplan-Meier method.	1, 3, 5 years from study entry
Secondary	Overall Survival (OS)	OS will be reported as estimates using the Kaplan-Meier method.	1, 3, 5 years from study entry

External Links

•   Clinical Trials Open at St. Jude
•   St. Jude Children's Research Hospital