OncRef

Clinical Trial: NCT02112916

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

Status:

ACTIVE NOT RECRUITING

Phase:

Phase 3

Lead Sponsor:National Cancer Institute (NCI)
Information Provided By:National Cancer Institute (NCI)
Last Update Posted:2026-10-21

Study Overview

Brief Summary

This randomized phase III trial compares how well combination chemotherapy works when given with or without bortezomib in treating patients with newly diagnosed T-cell acute lymphoblastic leukemia or stage II-IV T-cell lymphoblastic lymphoma. Bortezomib may help reduce the number of leukemia or lymphoma cells by blocking some of the enzymes needed for cell growth. It may also help chemotherapy work better by making cancer cells more sensitive to the drugs. It is not yet known if giving standard chemotherapy with or without bortezomib is more effective in treating newly diagnosed T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma.

Official Title

A Phase III Randomized Trial Investigating Bortezomib (NSC# 681239) on a Modified Augmented BFM (ABFM) Backbone in Newly Diagnosed T-Lymphoblastic Leukemia (T-ALL) and T-Lymphoblastic Lymphoma (T-LLy)

Conditions

Adult T Acute Lymphoblastic Leukemia, Ann Arbor Stage II Adult Lymphoblastic Lymphoma, Ann Arbor Stage II Childhood Lymphoblastic Lymphoma, Ann Arbor Stage III Adult Lymphoblastic Lymphoma, Ann Arbor Stage III Childhood Lymphoblastic Lymphoma, Ann Arbor Stage IV Adult Lymphoblastic Lymphoma, Ann Arbor Stage IV Childhood Lymphoblastic Lymphoma, Childhood T Acute Lymphoblastic Leukemia

Intervention / Treatment

  • Drug: Bortezomib
  • Drug: Cyclophosphamide
  • Drug: Cytarabine
  • Drug: Daunorubicin
  • Drug: Daunorubicin Hydrochloride
  • Drug: Dexamethasone
  • Drug: Doxorubicin
  • Drug: Doxorubicin Hydrochloride
  • Drug: Etoposide
  • Drug: Hydrocortisone Sodium Succinate
  • Drug: Ifosfamide
  • Drug: Leucovorin Calcium
  • Drug: Mercaptopurine
  • Drug: Methotrexate
  • Drug: Pegaspargase
  • Radiation: Radiation Therapy
  • Drug: Thioguanine
  • Drug: Vincristine
  • Drug: Vincristine Sulfate

Other Study ID Numbers

  • NCI-2014-00712
  • NCI-2014-00712
  • s14-01925
  • AALL1231
  • AALL1231
  • U10CA098543
  • U10CA180886

Start Date (Actual)

2014-10-04

Primary Completion Date (Actual)

2020-03-31

Study Completion Date (Estimated)

2027-09-16

Enrollment (Actual)

847

Study Type

Interventional

Phase

Phase 3