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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I have been recently diagnosed with T-ALL or T-LLy at stage II-IV.
Select...
I am between 1 and 31 years old.
Select...
I have been diagnosed with T-ALL based on specific markers in my blood or bone marrow.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Event-free Survival (EFS) for Modified Augmented Berlin-Frankfurt-Munster Backbone With or Without Bortezomib in All Randomized Patients
Secondary outcome measures
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 moreTrial 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
2013
Completed Phase 4
~4940
Cyclophosphamide
1995
Completed Phase 3
~3770
Daunorubicin Hydrochloride
2011
Completed Phase 3
~5110
Dexamethasone
2007
Completed Phase 4
~2590
Doxorubicin Hydrochloride
2019
Completed Phase 3
~17850
Hydrocortisone Sodium Succinate
2008
Completed Phase 3
~70
Mercaptopurine
2012
Completed Phase 4
~12330
Methotrexate
2013
Completed Phase 4
~3800
Thioguanine
2012
Completed Phase 4
~10830
Leucovorin Calcium
2011
Completed Phase 3
~12310
Radiation Therapy
2017
Completed Phase 3
~7250
Bortezomib
2005
Completed Phase 2
~1060
Cytarabine
2016
Completed Phase 3
~3310
Etoposide
2010
Completed Phase 3
~2440
Doxorubicin
2012
Completed Phase 3
~7940
Ifosfamide
2010
Completed Phase 4
~2980
Pegaspargase
2005
Completed Phase 3
~9010
Vincristine
2003
Completed Phase 4
~2910
Vincristine Sulfate
2005
Completed Phase 3
~10150
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,717 Previous Clinical Trials
40,952,516 Total Patients Enrolled
David T TeacheyPrincipal InvestigatorChildren's Oncology Group
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been recently diagnosed with T-ALL or T-LLy at stage II-IV.I've taken steroids for no more than 5 days in the last week or 14 days in the last month.I have not had chemotherapy for my current T-ALL or T-L-Ly diagnosis before starting treatment on AALL1231.I have received or need 600 cGy of chest radiation for medical reasons.I am between 1 and 31 years old.I have significant nerve damage affecting my senses or movement.I have been diagnosed with T-ALL based on specific markers in my blood or bone marrow.I have been treated with hydroxyurea.I haven't been in other drug trials within the last 14 days, or taken bortezomib in the last 30 days.I haven't taken dexamethasone in the last 28 days, except possibly a single dose for sedation.I have had a spinal fluid test before starting chemotherapy, except for steroids.You have a severe medical or mental health condition that could make it difficult for you to take part in this study.You are allergic to bortezomib, boron, or mannitol.I have seizures that are not controlled by medication.I have been diagnosed with Down syndrome.I am not pregnant and willing to take a pregnancy test if capable of becoming pregnant.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A (combination chemotherapy)
- Group 2: Arm B (combination chemotherapy, bortezomib)
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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