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Alkylating Agent

Combination Chemotherapy +/− Bortezomib for Lymphoma

Phase 3

Waitlist Available

Led By David T Teachey

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have newly diagnosed T-lymphoblastic leukemia (T-ALL) or T-lymphoblastic lymphoma (T-LLy) stages II-IV

All patients must be > 1 and < 31 years of age

Must not have

Pre-existing >= grade 2 sensory or motor peripheral neurotoxicity

Pretreatment with hydroxyurea; or

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is comparing how well two different combination chemotherapies work in treating patients with newly diagnosed T-cell acute lymphoblastic leukemia or stage II-IV T-cell lymphoblastic lymphoma.

Who is the study for?

This trial is for young patients aged 1-30 with newly diagnosed T-cell acute lymphoblastic leukemia or stage II-IV T-cell lymphoblastic lymphoma. They must not have Down syndrome, uncontrolled seizures, a history of severe reactions to bortezomib or its components, be pregnant/breastfeeding, or have used certain medications recently.

What is being tested?

The study tests if adding bortezomib to standard chemotherapy is more effective for treating T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma. Patients are randomly assigned to receive either the usual chemotherapy alone or with bortezomib.

What are the potential side effects?

Bortezomib can cause side effects like nausea, fatigue, diarrhea, low blood counts increasing infection risk, nerve damage causing numbness or pain in hands/feet (neuropathy), and allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been recently diagnosed with T-ALL or T-LLy at stage II-IV.

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I am between 1 and 31 years old.

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I have been diagnosed with T-ALL based on specific markers in my blood or bone marrow.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have significant nerve damage affecting my senses or movement.

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I have been treated with hydroxyurea.

Select...

I have seizures that are not controlled by medication.

Select...

I have been diagnosed with Down syndrome.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Event-free Survival (EFS) for Modified Augmented Berlin-Frankfurt-Munster Backbone With or Without Bortezomib in All Randomized Patients

Secondary study objectives

Cumulative Incidence Rates of Isolated Central Nervous System (CNS) Relapse for SR and IR T-ALL Patients on the Non-bortezomib Containing Arm on This Study (no CRT) and Similar Patients on AALL0434 (Receive CRT)

EFS for Standard (SR) and Intermediate Risk (IR) T-ALL Patients on the Non-bortezomib Containing Arm on This Study (no Cranial Radiation Therapy [CRT]) and Similar Patients on AALL0434 (Received CRT)

EFS for Very High Risk (VHR) T-ALL Patients Treated With High Risk (HR) Berlin-Frankfurt-Munster (BFM) Intensification Blocks Who Become Minimal Residual Disease (MRD) Negative and Those Who Remain MRD Positive at the End of HR Block 3

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm B (combination chemotherapy, bortezomib)Experimental Treatment19 Interventions

Patients receive combination chemotherapy with bortezomib (4 doses at 1.3 mg/m\^2 during Induction and 4 doses at 1.3 mg/m\^2 during Delayed Intensification). See Detailed Description.

Group II: Arm A (combination chemotherapy)Active Control18 Interventions

Patients receive combination chemotherapy without bortezomib. See Detailed Description.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Daunorubicin Hydrochloride

2011

Completed Phase 3

~5330

Thioguanine

2012