Trial Watch: 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

Evidence stage: Later-Stage HumanRegulatory status: InvestigationalGuideline status: Not addressed

Important context

In plain English

The 30-second version

What happened?

ClinicalTrials.gov confirms that this Phase 3 study is registered and currently listed as Active Not Recruiting. This establishes the study's existence and registry-reported design/status, not a treatment benefit.

Why does it matter?

Phase 3 trials can contribute later-stage human evidence. CancerDiscoveries can track this record as results and regulatory information emerge.

What does this not prove?

A registered trial is not proof that the intervention works, is not FDA approval for this cancer or use, and is not a clinical-guideline recommendation.

Keep reading for evidence stage, limitations, study details, and sources.

What changed: ClinicalTrials.gov lists 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 (NCT02112916) as a Phase 3 interventional cancer study. The registry status is Active Not Recruiting, with the record last updated 2026-10-21.

Study snapshot: Phase 3; Active Not Recruiting; planned enrollment 847. Conditions listed: 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. A primary outcome listed by the registry is: Event-free Survival (EFS) for Modified Augmented Berlin-Frankfurt-Munster Backbone With or Without Bortezomib in All Randomized Patients.

This entry tracks verified trial-registry facts. Trial registration by itself does not show that an intervention is effective, safe for a particular person, FDA-approved for this use, or recommended by clinical guidelines.

Population / Applicability

Studied in: Participants ages 1 Year to 30 Years with 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 who meet the study-specific registry eligibility criteria. (Mixed / all ages)

Eligibility is study-specific. Registry information does not determine whether any individual should enroll in or receive the intervention.

Full evidence details
Study design
Other / not applicable
Sample size
847
Primary outcome
Event-free Survival (EFS) for Modified Augmented Berlin-Frankfurt-Munster Backbone With or Without Bortezomib in All Randomized Patients
Replication
Unknown

Funding & Conflicts

ClinicalTrials.gov lists the lead sponsor as National Cancer Institute (NCI). Sponsorship is reported for transparency and does not establish efficacy.

Regulatory status by jurisdiction

Unspecified jurisdiction

Status
Investigational
Last verified
2026-10-22

This record has no structured cancer-type scope on file yet — editorial review recommended before treating it as applicable to a specific cancer type.

Guideline positions

Guideline

Position
Not addressed
Last verified
2026-10-22

Primary evidence supporting this story

Last reviewed

Trial Watch: 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

https://cancerdiscoveries.com/discoveries/trial-watch-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/

Evidence stage: Later-Stage Human

What This Means

ClinicalTrials.gov confirms that this Phase 3 study is registered and currently listed as Active Not Recruiting. This establishes the study's existence and registry-reported design/status, not a treatment benefit.

What This Doesn't Mean

A registered trial is not proof that the intervention works, is not FDA approval for this cancer or use, and is not a clinical-guideline recommendation.

Why It Matters

Phase 3 trials can contribute later-stage human evidence. CancerDiscoveries can track this record as results and regulatory information emerge.

Important Limitations

  • Clinical-trial participation has study-specific eligibility criteria; registry listing does not mean a person qualifies or should enroll.

Primary sources

  • ClinicalTrials.gov — NCT02112916 — https://clinicaltrials.gov/study/NCT02112916 (NCT02112916)

Date verified: 2026-10-22

Correction status: No correction or retraction