T-cell Lymphoblastic Lymphoma

• CLINICAL_TRIALS research · 2024-11-12
  Clinical Trial Update: Sequential CAR-T Cells Therapy for CD5/CD7 Positive T-cell Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma Using CD5/CD7-Specific CAR-T Cells [Phase 1, Phase 2]

  An ongoing Phase 1/2 clinical trial evaluating sequential CD5/CD7-specific CAR-T cells for CD5/CD7-positive T-cell malignancies including T-…

• FDA approval · 2024-09-13
  FDA Approved: NELARABINE — Original Application (Novadoz Pharmaceuticals LLC)

  The FDA approved an original-application abbreviated new drug application for nelarabine from Novadoz Pharmaceuticals LLC, enabling the mark…

• FDA approval · 2024-09-05
  FDA Approved: NELARABINE — Original Application (XGen Pharmaceuticals DJB, Inc.)

  FDA approved the original application for nelarabine as a generic drug, with XGen Pharmaceuticals DJB, Inc. listed as the manufacturer.

• FDA approval · 2024-08-01
  FDA Approved: NELARABINE — Original Application (Alembic Pharmaceuticals Limited)

  The FDA approved Alembic Pharmaceuticals Limited's Nelarabine Original Application (ANDA 218554), granting approval for a generic Nelarabine…

• CLINICAL_TRIALS withdrawal · 2024-05-17
  Clinical Trial Update: 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) [Phase 2]

  This clinical trial update notes withdrawal of a Phase 2 study evaluating adding targeted drugs to standard chemotherapy for adults with new…

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• FDA approval · 2024-01-03
  FDA Approved: NELARABINE — Original Application (Sagent Pharmaceuticals)

  FDA approved Nelarabine under an Original Application from Sagent Pharmaceuticals. It is indicated for T-cell acute lymphoblastic leukemia a…

• FDA approval · 2023-03-03
  FDA Approved: NELARABINE — Original Application (Shorla Oncology Inc.)

  The FDA approved a generic Nelarabine (Shorla Oncology Inc.) under an Original Abbreviated New Drug Application, confirming bioequivalence t…

• FDA approval · 2023-01-10
  FDA Approved: NELARABINE — Original Application (Meitheal Pharmaceuticals Inc)

  FDA approves Meitheal Pharmaceuticals' nelarabine original application (ANDA216038) for a generic formulation of nelarabine.

• FDA approval · 2022-12-22
  FDA Approved: NELARABINE — Original Application (Dr. Reddy's Laboratories, Inc.)

  FDA approves Dr. Reddy's Nelarabine as a generic under an Original Application for use in treating T-cell acute lymphoblastic leukemia and T…

• CLINICAL_TRIALS trial_result · 2022-08-18
  Clinical Trial Update: 506U78 In Relapsed Or Refractory Acute Lymphoblastic Leukemia (T-ALL) [Phase 2]

  Phase 2 clinical trial update for 506U78 in relapsed or refractory acute lymphoblastic leukemia (T-ALL) and T-NHL (lymphoblastic).

• CLINICAL_TRIALS trial_result · 2022-02-23
  Clinical Trial Update: Combination Chemotherapy With or Without Bortezomib in Treating Younger Patients With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia or Stage II-IV T-Cell Lymphoblastic Lymphoma [Phase 3]

  A Phase 3 clinical trial evaluating combination chemotherapy with or without bortezomib in younger patients with newly diagnosed T-cell acut…

• CLINICAL_TRIALS trial_result · 2022-02-23
  Clinical Trial Update: Combination Chemotherapy With or Without Bortezomib in Treating Younger Patients With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia or Stage II-IV T-Cell Lymphoblastic Lymphoma [Phase 3]

  A Phase 3 trial evaluating whether adding bortezomib to combination chemotherapy improves outcomes in younger patients with newly diagnosed …

• FDA approval · 2021-11-17
  FDA Approved: NELARABINE — Original Application (Zydus Lifesciences Limited)

  FDA approved the original application for Nelarabine from Zydus Lifesciences Limited, enabling generic access for treating T-cell acute lymp…

• CLINICAL_TRIALS trial_result · 2020-10-01
  Clinical Trial Update: Trial of Nelarabine, Etoposide and Cyclophosphamide in Relapsed T-cell ALL and T-cell LL [Phase 1, Phase 2]

  Phase 1/2 trial evaluating nelarabine combined with etoposide and cyclophosphamide in relapsed T-cell ALL and T-cell lymphoblastic lymphoma;…

• FDA approval · 2019-08-02
  FDA Approved: ARRANON — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for ARRANON (nelarabine) submitted by Sandoz Inc.

• CLINICAL_TRIALS trial_result · 2019-06-20
  Clinical Trial Update: Combination Chemotherapy in Treating Young Patients With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia or T-cell Lymphoblastic Lymphoma [Phase 3]

  Phase 3 clinical trial update on combination chemotherapy for newly diagnosed T-cell acute lymphoblastic leukemia or T-cell lymphoblastic ly…

• CLINICAL_TRIALS trial_result · 2019-02-06
  Clinical Trial Update: A Study of LY3039478 in Combination With Dexamethasone in Participants With T-ALL/T-LBL [Phase 1, Phase 2]

  Clinical trial update for LY3039478 in combination with dexamethasone in T-ALL/T-LBL (Phase 1/Phase 2) completed with results posted in 2019…

• FDA approval · 2018-11-29
  FDA Approved: ARRANON — Supplemental Application (Sandoz Inc)

  The FDA approved a supplemental application for ARRANON (nelarabine) submitted by Sandoz Inc.

• FDA approval · 2018-07-03
  FDA Approved: ARRANON — Supplemental Application (Sandoz Inc)

  The FDA approved Sandoz Inc.'s supplemental application for ARRANON (nelarabine), resulting in a labeling update for the product.

• CLINICAL_TRIALS research · 2018-06-21
  Clinical Trial Update: Precision Diagnosis Directing HDACi Chidamide Target Therapy for Adult T-LBL/ALL [Phase 2, Phase 3]

  Clinical trial update for chidamide-based targeted therapy in adult T-cell lymphoblastic leukemia/lymphoma (T-LBL/ALL), spanning Phase 2 and…

• CLINICAL_TRIALS trial_result · 2017-11-01
  Clinical Trial Update: Drug Use Investigation for ARRANON G (Nelarabine) Injection 250mg

  Clinical trial update reporting a drug use investigation for nelarabine (ARRANON G) injection 250 mg.

• CLINICAL_TRIALS withdrawal · 2016-12-20
  Clinical Trial Update: Salvage Therapy With Chemotherapy and Natural Killer Cells in Relapsed/Refractory Paediatric T Cell Lymphoblastic Leukaemia and Lymphoma [Phase 1, Phase 2]

  This terminated Phase 1/Phase 2 trial studied salvage therapy combining chemotherapy and natural killer (NK) cell therapy for relapsed or re…

• FDA approval · 2015-06-04
  FDA Approved: ARRANON — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for ARRANON (nelarabine) from Sandoz Inc. Nelarabine is indicated for T-cell acute lymphoblastic leu…

• CLINICAL_TRIALS trial_result · 2014-04-24
  Clinical Trial Update: Pilot Study of Expanded, Donor Natural Killer Cell Infusions for Refractory Non-B Lineage Hematologic Malignancies and Solid Tumors [Phase 1]

  Phase 1 pilot study evaluating donor-derived natural killer cell infusions for refractory non-B lineage hematologic cancers and solid tumors…

• CLINICAL_TRIALS trial_result · 2013-06-20
  Clinical Trial Update: 506U78 in Treating Patients With Relapsed or Refractory T-cell Acute Lymphoblastic Leukemia or T-cell Lymphoblastic Lymphoma [NA]

  Clinical trial update on the use of 506U78 for relapsed or refractory T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma;…