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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 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.

Timeline

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

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 more

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
~5070
Daunorubicin
2013
Completed Phase 4
~4940
Cyclophosphamide
1995
Completed Phase 3
~3780
Dexamethasone
2007
Completed Phase 4
~2590
Doxorubicin Hydrochloride
2019
Completed Phase 3
~17850
Hydrocortisone Sodium Succinate
2008
Completed Phase 3
~70
Bortezomib
2005
Completed Phase 2
~1140
Cytarabine
2016
Completed Phase 3
~3310
Etoposide
2010
Completed Phase 3
~2440
Doxorubicin
2012
Completed Phase 3
~7940
Ifosfamide
2010
Completed Phase 4
~2980
Leucovorin Calcium
2011
Completed Phase 3
~12290
Mercaptopurine
2012
Completed Phase 4
~12330
Methotrexate
2013
Completed Phase 4
~3800
Pegaspargase
2005
Completed Phase 3
~9010
Radiation Therapy
2017
Completed Phase 3
~7250
Thioguanine
2012
Completed Phase 4
~10830
Vincristine
2003
Completed Phase 4
~2920
Vincristine Sulfate
2005
Completed Phase 3
~10120

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,607 Previous Clinical Trials
40,913,315 Total Patients Enrolled
David T TeacheyPrincipal InvestigatorChildren's Oncology Group

Media Library

Cyclophosphamide (Alkylating Agent) Clinical Trial Eligibility Overview. Trial Name: NCT02112916 — Phase 3
Lymphoblastic Lymphoma Research Study Groups: Arm A (combination chemotherapy), Arm B (combination chemotherapy, bortezomib)
Lymphoblastic Lymphoma Clinical Trial 2023: Cyclophosphamide Highlights & Side Effects. Trial Name: NCT02112916 — Phase 3
Cyclophosphamide (Alkylating Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02112916 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there harmful side effects to Arm B (combination chemotherapy, bortezomib)?

"Arm B, which is a combination chemotherapy treatment involving bortezomib, has been given a 3 for safety. This decision was made by our team at Power because Phase 3 trials have shown some efficacy and multiple rounds of data support the notion that it is safe."

Answered by AI

How many individuals are part of this research project?

"This clinical trial is not currently recruiting participants. It was first posted on 9/30/2014 and last updated on 1/26/2022. There are 2972 other trials actively recruiting participants with lymphoma and 2277 trials for Arm B (combination chemotherapy, bortezomib) enrolling patients at this time."

Answered by AI

What cancerous growths does Arm B (combination chemotherapy, bortezomib) work best against?

"Arm B (combination chemotherapy, bortezomib) is not only for macular edema. It can also help with pheochromocytomas, eye conditions, and ulcerative colitis."

Answered by AI

Is this clinical trial being run in many places across North America?

"Right now, this trial is looking for volunteers from a total of 100 hospitals. The specific locations are Durham, Greenville and Sacramento; however, there are many other options available too. By selecting the location closest to you, participating will be more convenient."

Answered by AI

What are the goals that researchers are hoping to achieve with this clinical trial?

"The aim of this trial, which will take place over a period of 3 years, is to improve Event-free Survival (EFS) rates for patients with modified Augmented Berlin-Frankfurt-Munster Backbone cancer. Additionally, the study hopes to observe differences in EFS between those treated with or without bortezomib. Secondary objectives include understanding EFS rates for very high risk (VHR) T-cell lymphoblastic lymphoma patients treated according different intensification blocks – specifically among those who enter remission and those who do not respond to therapy. Three-year EFS will be calculated for all"

Answered by AI

What is the age limit for participants in this research project?

"This particular clinical trial is only for patients that are aged 1 to 30 years old. Out of the 1145 trials taking place for patients under 18 and the 4427 trials available for adults over 65, this is one of the few."

Answered by AI

Could you please list any other research that has been conducted on Arm B (combination chemotherapy, bortezomib)?

"The first trial for Arm B (combination chemotherapy, bortezomib) was at National Institutes of Health Clinical Center in 1995. 4410 trials have completed since then. There are 2277 studies currently being performed with many taking place in Durham, North carolina."

Answered by AI

Is there still room for participants in this research project?

"This specific trial is not currently looking for more participants, as it was last updated over half a year ago. However, there are nearly 3000 other trials actively enrolling patients with lymphoma and almost 2300 trials specifically involving Arm B (combination chemotherapy, bortezomib)."

Answered by AI

If I wanted to help out with this research, how could I get involved?

"This study is searching for 847 individuals between the ages of 1 year and 30 who have been diagnosed with lymphoma. Tissue samples must be available for flow cytometry analysis, and patients must meet the following criteria: All patients must be > 1 and < 31 years of age, For T-LLy patients with tissue available for flow cytometry, the criterion for diagnosis should be analogous to T-ALL; for tissue processed by other means (i.e. paraffin blocks), the methodology and criteria for immunophenotypic analysis to establish the diagnosis of T-LLy defined by the submitting institution will be"

Answered by AI
~81 spots leftby Mar 2025