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Alkylating agents

Chemotherapy for Leukemia and Lymphoma

Phase 3
Waitlist Available
Led By Anne L Angiolillo
Research Sponsored by Children's Oncology Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must have newly diagnosed National Cancer Institute (NCI) Standard Risk B-ALL or B-LLy Murphy stages I or II; patients with Down syndrome are also eligible
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5.7 years
Awards & highlights

Study Summary

This trial is testing different combinations of chemotherapy drugs to treat patients with newly diagnosed standard-risk acute lymphoblastic leukemia or B-lineage lymphoblastic lymphoma.

Who is the study for?
This trial is for young patients with newly diagnosed standard-risk acute lymphoblastic leukemia or localized B-lineage lymphoblastic lymphoma. They must not have had previous cancer treatments, except certain steroids or intrathecal cytarabine. Patients need to agree to use effective contraception if applicable and meet all study requirements.Check my eligibility
What is being tested?
The trial tests different combinations of chemotherapy drugs on younger patients with specific types of leukemia or lymphoma. It aims to find the best mix and dosage that kills the most cancer cells while monitoring side effects through various stages of treatment.See study design
What are the potential side effects?
Chemotherapy drugs like Dexamethasone, Mercaptopurine, and others may cause nausea, hair loss, fatigue, increased risk of infection due to low blood cell counts, mouth sores, and potential damage to organs such as the heart or liver.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been newly diagnosed with a specific type of leukemia and may have Down syndrome.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5.7 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5.7 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
DFS for SR Down Syndrome Patients With Standardized Treatment and Enhanced Supportive Care
DFS in Average Risk (AR) Patients Based on the Pulse Frequency Randomization
DFS in Low Risk (LR) Patients Based on Randomization to 1 of 2 Low-intensity Regimens
+4 more
Secondary outcome measures
Tumor Burden
Burden of Therapy in AR Patients Overall at End of Consolidation Therapy: Physical
Tumor Burden
+39 more

Side effects data

From 2013 Phase 4 trial • 122 Patients • NCT01474915
2%
Deep Vein Thrombosis
2%
Cerebrospinal fluid leak
2%
Fever
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ondansetron
Aprepitant

Trial Design

8Treatment groups
Experimental Treatment
Group I: Arm SR DS (12-week cycle maintenance)Experimental Treatment13 Interventions
See Detailed Description
Group II: Arm LR-M (risk-adapted chemotherapy)Experimental Treatment8 Interventions
Patients receive consolidation and maintenance therapy. See detailed description.
Group III: Arm LR-C (risk-adapted chemotherapy)Experimental Treatment12 Interventions
Patients receive consolidation, interim maintenance I, delayed intensification, interim maintenance II, and maintenance therapy. See detailed description.
Group IV: Arm D (risk-adapted chemotherapy)Experimental Treatment7 Interventions
Patients receive vincristine sulfate IV on day 1; dexamethasone PO BID on days 1-5; higher-dose methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; mercaptopurine PO on days 1-84; and IT methotrexate on day 1.
Group V: Arm C (risk-adapted chemotherapy)Experimental Treatment7 Interventions
Patients receive vincristine sulfate IV on day 1; dexamethasone PO BID on days 1-5; methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; mercaptopurine PO on days 1-84; and IT methotrexate on day 1.
Group VI: Arm B-LLy (4-week cycle maintenance)Experimental Treatment13 Interventions
See Detailed Description.
Group VII: Arm B (risk-adapted chemotherapy)Experimental Treatment7 Interventions
Patients receive vincristine sulfate IV on days 1, 29, and 57; dexamethasone PO BID on days 1-5, 29-33, and 57-61; higher-dose methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; mercaptopurine PO on days 1-84; and IT methotrexate on day 1.
Group VIII: Arm A (risk-adapted chemotherapy)Experimental Treatment7 Interventions
Patients receive vincristine sulfate IV on days 1, 29, and 57; dexamethasone PO BID on days 1-5, 29-33, and 57-61; methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; mercaptopurine PO on days 1-84; and IT methotrexate on day 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mercaptopurine
2012
Completed Phase 4
~12330
Dexamethasone
2007
Completed Phase 4
~2590
Vincristine Sulfate
2005
Completed Phase 3
~10110
Cyclophosphamide
1995
Completed Phase 3
~3780
Cytarabine
2016
Completed Phase 3
~3310
Doxorubicin Hydrochloride
2019
Completed Phase 3
~17850
Leucovorin Calcium
2011
Completed Phase 3
~12290
Methotrexate
2013
Completed Phase 4
~3800
Pegaspargase
2005
Completed Phase 3
~9010
Thioguanine
2012
Completed Phase 4
~10830

Find a Location

Who is running the clinical trial?

Children's Oncology GroupLead Sponsor
453 Previous Clinical Trials
228,350 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,923,803 Total Patients Enrolled
Anne L AngiolilloPrincipal InvestigatorChildren's Oncology Group
1 Previous Clinical Trials
166 Total Patients Enrolled

Media Library

Cyclophosphamide (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT01190930 — Phase 3
Acute Lymphoblastic Leukemia Research Study Groups: Arm A (risk-adapted chemotherapy), Arm B (risk-adapted chemotherapy), Arm B-LLy (4-week cycle maintenance), Arm C (risk-adapted chemotherapy), Arm D (risk-adapted chemotherapy), Arm LR-C (risk-adapted chemotherapy), Arm LR-M (risk-adapted chemotherapy), Arm SR DS (12-week cycle maintenance)
Acute Lymphoblastic Leukemia Clinical Trial 2023: Cyclophosphamide Highlights & Side Effects. Trial Name: NCT01190930 — Phase 3
Cyclophosphamide (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01190930 — Phase 3

Frequently Asked Questions

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

For what sorts of medical issues is Dexamethasone generally prescribed?

"Dexamethasone is a common medication used to treat pheochromocytomas. Additionally, this medication can be used to manage other conditions such as ulcerative colitis, certain types of viral eye infections, and varicella-zoster virus acute retinal necrosis."

Answered by AI

Is this medical study novel in terms of its approach or treatments?

"Currently, 2036 different clinical trials testing Dexamethasone are ongoing in 88 countries and 3496 cities. The first such trial began in 1997 and, sponsored by Alfacell, completed its Phase 3 drug approval stage with 300 participants. In the years since 1997, 4265 Dexamethasone trials have been conducted."

Answered by AI

How many separate places are coordinating this experiment?

"The trial is based out of AdventHealth Orlando in Orlando, Florida, Yale University in New Haven, Connecticut, El Paso Children's Hospital in El Paso, Texas; as well as 100 other sites."

Answered by AI

Are there any positions available in this research project for participants?

"The clinical trial in question is not presently looking for new patients, however, this may change in the future. The original posting date was 8/9/2010, with the most recent edit on 7/8/2022. Although this study is not recruiting candidates at this time, there are 5036 other studies presently accepting participants."

Answered by AI

If I take part in this experiment, will I be able to complete it?

"Eligibility requirements for this clinical trial include having down syndrome and being between 1 and 30 years old. The total number of participants that the study is hoping to recruit is 9350 individuals."

Answered by AI

Are people of legal age welcome in this research project?

"This trial is for patients aged 1 year to 30 years old. Out of 4251 trials for patients over 65 and 1129 trials for those under 18, this is the only study that meets the specified age range."

Answered by AI

Has Dexamethasone undergone drug trials by the FDA?

"Dexamethasone has received a rating of 3 from our team at Power. This means that, while it is a phase 3 trial medication, there is some data supporting its efficacy as well as multiple rounds of data supporting its safety."

Answered by AI

Are there any other papers which mention Dexamethasone?

"The first documented use of dexamethasone was in 1997 at Spectrum Health Hospital - Butterworth Campus. In the years since, 4265 similar studies have been completed with 2036 currently active. A large number of these active studies are based in Orlando, Florida."

Answered by AI
~637 spots leftby Apr 2025