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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 belowSelect...
I have been newly diagnosed with a specific type of leukemia and may have Down syndrome.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5.7 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5.7 years
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 moreSecondary outcome measures
Tumor Burden
Burden of Therapy in AR Patients Overall at End of Consolidation Therapy: Physical
Tumor Burden
+39 moreSide effects data
From 2013 Phase 4 trial • 122 Patients • NCT014749152%
Cerebrospinal fluid leak
2%
Deep Vein Thrombosis
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
~10150
Cyclophosphamide
1995
Completed Phase 3
~3770
Cytarabine
2016
Completed Phase 3
~3310
Doxorubicin Hydrochloride
2019
Completed Phase 3
~17850
Leucovorin Calcium
2011
Completed Phase 3
~12310
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
456 Previous Clinical Trials
230,436 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,717 Previous Clinical Trials
40,944,013 Total Patients Enrolled
Anne L AngiolilloPrincipal InvestigatorChildren's Oncology Group
1 Previous Clinical Trials
166 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had chemotherapy for my current B-ALL/B-LLy or any cancer before starting the AALL0932 protocol, except for steroids or intrathecal cytarabine.Your white blood cell count at the start of the study should be less than 50,000 cells per microliter.I am not pregnant or have a negative pregnancy test if of childbearing age.I am using effective birth control during the study.I am currently pregnant.I have been newly diagnosed with a specific type of leukemia and may have Down syndrome.My leukemia has spread to my brain or spinal cord.My leukemia has spread to my brain/spinal cord or testicles.My leukemia involves a specific range of immature blood cells.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A (risk-adapted chemotherapy)
- Group 2: Arm B (risk-adapted chemotherapy)
- Group 3: Arm B-LLy (4-week cycle maintenance)
- Group 4: Arm C (risk-adapted chemotherapy)
- Group 5: Arm D (risk-adapted chemotherapy)
- Group 6: Arm LR-C (risk-adapted chemotherapy)
- Group 7: Arm LR-M (risk-adapted chemotherapy)
- Group 8: Arm SR DS (12-week cycle maintenance)
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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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