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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