NELARABINE
Nelarabine treats T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma in both adults and children aged one year and older. It is used for patients whose disease has either relapsed or failed to respond after they have already tried at least two other chemotherapy regimens. This medication provides a therapeutic option for these specific T-cell cancers when previous treatments have not been effective.
How NELARABINE Works
This drug works by converting into an active metabolite called ara-GTP, which specifically accumulates within leukemic blast cells. Once inside, it incorporates into the cell's DNA to inhibit further DNA synthesis, ultimately leading to the death of the cancer cells.
Details
- Status
- Prescription
- First Approved
- 2021-11-17
- Routes
- INTRAVENOUS
- Dosage Forms
- INJECTABLE
NELARABINE Approval History
What NELARABINE Treats
2 indicationsNELARABINE is approved for 2 conditions since its original approval in 2021. These indications span multiple therapeutic areas including oncology, immunology, and more.
- T-Cell Acute Lymphoblastic Leukemia
- T-Cell Lymphoblastic Lymphoma
NELARABINE Boxed Warning
NEUROLOGIC ADVERSE REACTIONS See full prescribing information for complete boxed warning. Severe neurologic adverse reactions have been reported with the use of nelarabine injection. These adverse reactions have included altered mental states including severe somnolence, central nervous system effects including convulsions, and peripheral neuropathy ranging from numbness and paresthesias to motor weakness and paralysis. There have also been reports of adverse reactions associated with demyelinat...
WARNING: NEUROLOGIC ADVERSE REACTIONS See full prescribing information for complete boxed warning. Severe neurologic adverse reactions have been reported with the use of nelarabine injection. These adverse reactions have included altered mental states including severe somnolence, central nervous system effects including convulsions, and peripheral neuropathy ranging from numbness and paresthesias to motor weakness and paralysis. There have also been reports of adverse reactions associated with demyelination, and ascending peripheral neuropathies similar in appearance to Guillain-Barré syndrome. ( 5.1 ) Full recovery from these adverse reactions has not always occurred with cessation of therapy with nelarabine injection. Monitor frequently for signs and symptoms of neurologic toxicity. Discontinue nelarabine injection for neurologic adverse reactions of NCI Common Toxicity Criteria for Adverse Events (CTCAE) Grade 2 or greater. ( 5.1 ) WARNING: NEUROLOGIC ADVERSE REACTIONS Severe neurologic adverse reactions have been reported with the use of Nelarabine injection. These adverse reactions have included altered mental states including severe somnolence, central nervous system effects including convulsions, and peripheral neuropathy ranging from numbness and paresthesias to motor weakness and paralysis. There have also been reports of adverse reactions associated with demyelination, and ascending peripheral neuropathies similar in appearance to Guillain-Barré syndrome [see Warnings and Precautions ( 5.1 )] . Full recovery from these adverse reactions has not always occurred with cessation of therapy with nelarabine injection. Monitor frequently for signs and symptoms of neurologic toxicity during treatment with nelarabine injection. Discontinue nelarabine injection for neurologic adverse reactions of NCI Common Toxicity Criteria for Adverse Events (CTCAE) Grade 2 or greater [see Warnings and Precautions ( 5.1 )] .
NELARABINE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in NELARABINE's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications NELARABINE treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to NELARABINE
FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
13 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03808610 | 2016-0629 NCI-2018-03360, 2016-0629 | Ph 1, Ph 2 | terminated | Low-Intensity Chemotherapy and Venetoclax in Treating Patients With Relapsed or Refractory B- or T-Cell Acute Lymphoblastic Leukemia |
| NCT06390319 | SJALL23T NCI-2024-03015 | Ph 2 | recruiting | Adding Dasatinib Or Venetoclax To Improve Responses In Children With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia (ALL) Or Lymphoma (T-LLY) Or Mixed Phenotype Acute Leukemia (MPAL) |
| NCT07294677 CAVALRY | IRB25-1773 | Ph 1, Ph 2 | recruiting | CApivasertib, Venetoclax And Low-intensity chemotheRapY for Adults With ALL/LBL |
| NCT03020030 | 16-001 | Ph 3 | active not recruiting | Treatment of Newly Diagnosed Acute Lymphoblastic Leukemia in Children and Adolescents |
| NCT07072585 | AALL2331 NCI-2025-02230, AALL2331 | Ph 2, Ph 3 | not yet recruiting | Testing the Addition of Daratumumab to Chemotherapy for Treating Patients With Newly-Diagnosed T-Cell Lymphoblastic Leukemia (T-ALL) and T-Cell Lymphoblastic Lymphoma (T-LL) |
| NCT02881086 | GMALL08_2013 | Ph 3 | completed | Optimization of Therapy in Adult Patients With Newly Diagnosed Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma by Individualised, Targeted and Intensified Treatment |
| NCT03117751 | TOT17 NCI-2017-00582 | Ph 2, Ph 3 | active not recruiting | Total Therapy XVII for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia and Lymphoma |
| NCT06210750 | NCI-2023-09521 NCI-2023-09521, S2306 | Ph 2 | withdrawn | 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) |
| NCT02763384 results posted | 201606146 2P50CA171963-06 | Ph 2 | terminated | BL-8040 and Nelarabine for Relapsed or Refractory T-Acute Lymphoblastic Leukemia/ Lymphoblastic Lymphoma |
| NCT03328104 ENCERT | IRB00095500 | Ph 1 | completed | Everolimus in Combination With Nelarabine, Cyclophosphamide and Etoposide in Lymphoblastic Leukemia/Lymphoma |
| NCT00981799 results posted | T2008-002 | Ph 1, Ph 2 | terminated | Trial of Nelarabine, Etoposide and Cyclophosphamide in Relapsed T-cell ALL and T-cell LL |
| NCT01094860 | 2009-0717 NCI-2010-01659 | Ph 1 | completed | Pharmacokinetic (PK) and Pharmacodynamic (PD) Study of Nelarabine in Patients With Relapsed/Refractory Lymphoid Malignancies |
| NCT02518750 results posted | TSALV NCI-2015-00935 | Ph 2 | terminated | Re-Induction Therapy for Relapsed Pediatric T-Cell Acute Lymphoblastic Leukemia or Lymphoma |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
NELARABINE FDA Label Details
Indications & Usage
NELARABINE is indicated for the treatment of T-Cell Acute Lymphoblastic Leukemia; T-Cell Lymphoblastic Lymphoma.
WARNING: NEUROLOGIC ADVERSE REACTIONS See full prescribing information for complete boxed warning. Severe neurologic adverse reactions have been reported with the use of nelarabine injection. These adverse reactions have included altered mental states including severe somnolence, central nervous sys...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.