Adding Targeted Drugs to Usual Chemotherapy for Adults With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia (T-ALL) and T-Cell Lymphoblastic Lymphoma (T-LBL)

Sponsor
National Cancer Institute (NCI)
Study ID
NCT06210750
Phase
PHASE2
Status
Withdrawn

Conditions

  • T Acute Lymphoblastic Leukemia
  • T Lymphoblastic Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Bone Marrow Aspiration — PROCEDURE
    Undergo bone marrow aspiration
  • Bone Marrow Biopsy — PROCEDURE
    Undergo bone marrow biopsy
  • Calaspargase Pegol — DRUG
    Given IV
  • Computed Tomography — PROCEDURE
    Undergo CT
  • Cyclophosphamide — DRUG
    Given IV
  • Cytarabine — DRUG
    Given IT, IV or SC
  • Daunorubicin — DRUG
    Given IV
  • Dexamethasone — DRUG
    Given PO
  • Doxorubicin — DRUG
    Given IV
  • Echocardiography — PROCEDURE
    Undergo echocardiography
  • Lumbar Puncture — PROCEDURE
    Undergo lumbar puncture
  • Mercaptopurine — DRUG
    Given PO
  • Methotrexate — DRUG
    Given IT
  • Multigated Acquisition Scan — PROCEDURE
    Undergo MUGA scan
  • Navitoclax — BIOLOGICAL
    Given PO
  • Nelarabine — DRUG
    Given IV
  • Pegaspargase — DRUG
    Given IV
  • Positron Emission Tomography — PROCEDURE
    Undergo PET scan
  • Thioguanine — DRUG
    Given PO
  • Venetoclax — DRUG
    Given PO
  • Vincristine — DRUG
    Given IV
  • X-Ray Imaging — PROCEDURE
    Undergo X-ray

Study Details

This phase II trial tests the safety and effectiveness of giving chemotherapy with or without venetoclax and/or navitoclax for the treatment of patients with newly diagnosed T-cell acute lymphoblastic leukemia (T-ALL) or T-cell lymphoblastic lymphoma (T-LBL). Chemotherapy drugs work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Venetoclax and navitoclax are in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. They may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Giving chemotherapy with or without venetoclax and/or navitoclax may be effective treatments for patients with newly diagnosed T-ALL or T-LBL.

Key Dates

Start date
Aug 9, 2024
Status verified
May 2024
Primary completion
Sep 22, 2026
Completion
Sep 22, 2026

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Arm 1 (AALL0434 regimen)
    See detailed description for Arm 1
  • Experimental: Arm 2 (AALL0434 regimen with venetoclax)
    See detailed description for Arm 2
  • Experimental: Arm 3 (AALL0434 regimen with navitoclax)
    See detailed description for Arm 3
  • Experimental: Arm 4 (AALL0434 regimen with venetoclax and navitoclax)
    See detailed description for Arm 4
  • Active Comparator: Arm 5 (AALL0434 [no nelarabine])
    See detailed description for Arm 5
  • Experimental: Arm 6 (AALL0434 [no nelarabine] + navitoclax & venetoclax)
    See detailed description for Arm 6
  • Active Comparator: Arm 7 (AALL0434 regimen)
    See detailed description for Arm 7
  • Experimental: Arm 8 (Remission induction with venetoclax and navitoclax)
    See detailed description for Arm 8

Primary Outcome Measure

Incidence of adverse events (Cohorts 1, 2 and 3) [ Time Frame: Up to 10 years ]

Related Studies