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Alkylating agents
Chemotherapy Regimen for Acute Lymphoblastic Leukemia
Phase 3
Waitlist Available
Led By Lewis Silveman, MD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age: 365 days to < 22 years
Prior Therapy: No prior therapy is allowed except for the following:
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during post-induction therapy with 30-weeks of pegaspargase (15 doses), collected during the first 6 months of therapy for all participants through study completion (expected to take 4-5 years to accrue)
Awards & highlights
Study Summary
This trial is studying a new way to treat acute lymphoblastic leukemia (ALL). The new way involves using a new, updated set of risk factors to decide how strong the treatment will be and testing a new way of dosing a chemotherapy drug.
Who is the study for?
This trial is for children and adolescents aged 1 to less than 22 years with a confirmed diagnosis of acute lymphoblastic leukemia (ALL). They must not have had previous cancer treatments, except for short-term corticosteroids or emergent radiation. Participants need parental consent and cannot have chronic steroid use, HIV, uncontrolled illnesses, or be pregnant.Check my eligibility
What is being tested?
The study tests an updated set of risk factors to determine the intensity of ALL treatment in young patients. It also explores a new dosing method for pegaspargase based on drug levels in the blood. The trial includes various chemotherapy drugs like Doxorubicin and Vincristine over about two years.See study design
What are the potential side effects?
Chemotherapy drugs used may cause side effects such as nausea, vomiting, hair loss, fatigue, increased infection risk due to low blood cell counts, mouth sores, and potential damage to organs like the heart and liver.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 1 and 21 years old.
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I have not received any treatments except for allowed ones.
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I have not been on corticosteroids for more than 7 days in the last month or more than 28 days in the last 6 months.
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I have been diagnosed with acute lymphoblastic leukemia.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ during post-induction therapy with 30-weeks of pegaspargase (15 doses). collected during the first 6 months of therapy for all participants through study completion (expected to take 4-5 years to accrue)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during post-induction therapy with 30-weeks of pegaspargase (15 doses). collected during the first 6 months of therapy for all participants through study completion (expected to take 4-5 years to accrue)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Complete Remission Rate
Event-Free Survival
Secondary outcome measures
Disease Free Survival
Nadir Serum Asparaginase Activity (NSAA)
Non-allergic Asparaginase Toxicity
+1 moreSide effects data
From 2021 Phase 3 trial • 3154 Patients • NCT0007572572%
Neutrophil count decreased
57%
Infections and infestations - Other, specify
54%
Febrile neutropenia
47%
Alanine aminotransferase increased
39%
White blood cell decreased
39%
Platelet count decreased
32%
Hyperglycemia
27%
Anemia
24%
Aspartate aminotransferase increased
22%
Mucositis oral
19%
Hypokalemia
18%
Blood bilirubin increased
18%
Hyponatremia
16%
Anorexia
15%
Abdominal pain
15%
Vomiting
15%
Lipase increased
14%
Anaphylaxis
13%
Dehydration
13%
Headache
13%
Peripheral motor neuropathy
10%
Nausea
10%
Hypocalcemia
9%
Hypoalbuminemia
8%
Diarrhea
8%
Hypoxia
8%
Lung infection
8%
Peripheral sensory neuropathy
8%
Fibrinogen decreased
7%
Avascular necrosis
7%
Back pain
7%
Serum amylase increased
7%
Weight loss
7%
Enterocolitis infectious
6%
Depression
6%
Fever
6%
Hypotension
6%
Pancreatitis
6%
Hypophosphatemia
5%
Pain in extremity
5%
Arthralgia
5%
Epistaxis
5%
Lymphocyte count decreased
5%
Upper respiratory infection
5%
Hyperkalemia
5%
Skin infection
5%
Acute kidney injury
4%
GGT increased
4%
Pain
4%
Dyspnea
4%
Hypertension
4%
Oral pain
4%
Activated partial thromboplastin time prolonged
4%
Bone pain
4%
Typhlitis
4%
Hypertriglyceridemia
3%
Seizure
3%
Urinary tract infection
3%
Glucose intolerance
3%
Sinusitis
3%
Creatinine increased
3%
Encephalopathy
3%
Ileus
3%
Pneumonitis
3%
Syncope
3%
Anxiety
3%
Colitis
3%
Fatigue
3%
Rash maculo-papular
3%
Thromboembolic event
3%
Tumor lysis syndrome
3%
Nervous system disorders - Other, specify
3%
Esophagitis
3%
Catheter related infection
3%
Hypermagnesemia
2%
Cough
2%
Urticaria
2%
Disseminated intravascular coagulation
2%
Hemolysis
2%
Dysphagia
2%
Hypercalcemia
2%
Hepatic failure
2%
Acidosis
2%
Confusion
2%
Hypernatremia
2%
Non-cardiac chest pain
2%
Personality change
2%
Vascular disorders - Other, specify
2%
Anal mucositis
2%
Dysphasia
2%
Hypoglycemia
2%
INR increased
2%
Vascular access complication
2%
Pleural effusion
1%
Hepatobiliary disorders - Other, specify
1%
Abdominal infection
1%
Hematoma
1%
Capillary leak syndrome
1%
Gastrointestinal disorders - Other, specify
1%
Dizziness
1%
Allergic reaction
1%
Hepatic infection
1%
Psychosis
1%
Skin ulceration
1%
Pharyngitis
1%
Ascites
1%
Bone marrow hypocellular
1%
Facial nerve disorder
1%
Rectal pain
1%
Hyperuricemia
1%
Insomnia
1%
Intracranial hemorrhage
1%
Pancreas infection
1%
Pharyngeal mucositis
1%
Pneumothorax
1%
Proteinuria
1%
Muscle weakness lower limb
1%
Anal pain
1%
Cholecystitis
1%
Enterocolitis
1%
Hypomagnesemia
1%
Immune system disorders - Other, specify
1%
Investigations - Other, specify
1%
Iron overload
1%
Proctitis
1%
Respiratory, thoracic and mediastinal disorders - Other, specify
1%
Stomach pain
1%
Musculoskeletal and connective tissue disorder - Other, specify
1%
Weight gain
1%
Blood and lymphatic system disorders - Other, specify
1%
Adult respiratory distress syndrome
1%
Myositis
1%
Pharyngolaryngeal pain
1%
Gastritis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Dexamethasone & Capizzi Methotrexate Patients => 10 Years Old
Prednisone and High Dose Methotrexate (Non Randomly Assigned)
Prednisone and High Dose Methotrexate < 10 Yrs Old
Prednisone, Capizzi Methotrexate <10 Years
Dexamethasone, High Dose Methotrexate (IM) < 10 Years
Prednisone, Capezzi Methotrexate >= 10 Years
Dexamethasone and Capizzi Methotrexate Patients < 10 Years
Dexamethasone, High Dose Methotrexate (Non Randomly Assigned)
Prednisone and High Dose Methotrexate >=10 Years
Dexamethasone, High Dose Methotrexate (IM) >= 10 Years
Dexamethasone, Capizzi Methotrexate Down Syndrome (Non Random)
Prednisone, Capezzi Methotrexate (Down's Syndrome)
Trial Design
10Treatment groups
Experimental Treatment
Active Control
Group I: Reduced Dose (PK-Adjusted) PegaspargaseExperimental Treatment2 Interventions
Final LR, IR, HR patients who consent to randomization and are assigned to receive 15 doses of pegaspargase every 2-weeks beginning at a reduced dose (2000 IU/m2/dose); subsequent doses adjusted based on nadir serum asparaginase activity (NSAA) levels, with goal of maintaining NSAA between 0.4 and 1.0 IU/mL. Closed to Enrollment.
Group II: Initial Very High Risk (Initial VHR)Experimental Treatment15 Interventions
Any of the following are present: IKZF1 deletion, MLL (KMT2A) rearrangement, low hypodiploidy, t(17;19)
Treated with Induction IA (vincristine, dexamethasone, pegaspargase, doxorubicin + dexrazoxane), Induction IB (cyclophosphamide, cytarabine, mercaptopurine), Consolidation IA (vincristine, high-dose methotrexate + leucovorin, mercaptopurine). IT chemotherapy in all phases. Final risk group assigned by end of Consolidation IA.
Group III: Initial Low Risk (Initial LR)Experimental Treatment10 Interventions
Meets all the following criteria: B-ALL, Age 1-<15 years, WBC < 50,000/microliter, CNS-1 or CNS-2, no BCR-ABL1, no iAMP21, and no VHR characteristics.
Treated with Induction IA (vincristine, dexamethasone, pegaspargase), Induction IB (cyclophosphamide, cytarabine, mercaptopurine), Consolidation IA (vincristine, high-dose methotrexate + leucovorin, mercaptopurine). IT chemotherapy in all phases. Final risk group assigned by end of Consolidation IA.
Group IV: Initial High Risk (Initial HR)Experimental Treatment12 Interventions
Meets at least one of the following criteria: Age >=15 years, WBC >=50,000/microliter, CNS-3, T-ALL, iAMP21, BCR-ABL1
And: No VHR characteristics
Treated with Induction IA (vincristine, dexamethasone, pegaspargase, doxorubicin + dexrazoxane), Induction IB (cyclophosphamide, cytarabine, mercaptopurine), Consolidation IA (vincristine, high-dose methotrexate + leucovorin, mercaptopurine). IT chemotherapy in all phases. Final risk group assigned by end of Consolidation IA.
Group V: Final Very High Risk (Final VHR)Experimental Treatment15 Interventions
Initial VHR or any patient with high MRD (>=0.001) at second time point (week 10-12)
Final Risk Group assigned at end of Consolidation IA. Subsequent therapy as follows:
Consolidation IB/B-ALL (High-dose methotrexate + leucovorin, cyclophosphamide, etoposide, IT chemotherapy); Consolidation IB/T-ALL (nelararbine, cyclophosphamide, etoposide); Consolidation IC (High-dose cytarabine, etoposide, dexamethasone, pegaspargase [by direct assignment], IT chemotherapy); CNS phase (vincristine, dexamethasone, mercaptopurine, pegaspargase [by direct assignment], IT chemotherapy); Consolidation II (vincristine, dexamethasone, mercaptopurine, doxorubicin + dexrazoxane, pegaspargase [by direct assignment], IT chemotherapy); Continuation (vincristine, dexamethasone, mercaptopurine, methotrexate, IT chemotherapy).
Dasatinib administered daily during all phases to pts with ABL1-class fusions. All treatment completed 24 months from date of complete remission.
Group VI: Final Low Risk (Final LR)Experimental Treatment8 Interventions
Initial Low Risk and Low MRD (<0.0001) at first time point (Day 32)
Final Risk Group assigned at end of Consolidation IA. Subsequent therapy as follows:
CNS phase (vincristine, dexamethasone, mercaptopurine, pegaspargase [by randomization or direct assignment], IT chemotherapy); Consolidation II (vincristine, dexamethasone, mercaptopurine, methotrexate, pegaspargase [by randomization or direct assignment], IT chemotherapy); Continuation (vincristine, dexamethasone, mercaptopurine, methotrexate, IT chemotherapy).
All treatment completed 24 months from date of complete remission.
Group VII: Final Intermediate Risk (Final IR)Experimental Treatment10 Interventions
Initial High Risk and Low MRD (<0.0001) at first time point (Day 32)
Final Risk Group assigned at end of Consolidation IA. Subsequent therapy as follows:
CNS phase (vincristine, dexamethasone, mercaptopurine, pegaspargase [by randomization or direct assignment], IT chemotherapy); Consolidation II (vincristine, dexamethasone, mercaptopurine, doxorubicin + dexrazoxane, pegaspargase [by randomization or direct assignment], IT chemotherapy); Continuation (vincristine, dexamethasone, mercaptopurine, methotrexate, IT chemotherapy).
All treatment completed 24 months from date of complete remission.
Group VIII: Final High Risk (Final HR)Experimental Treatment10 Interventions
Initial Low Risk or Initial High Risk with High MRD (>=0.0001) at first time point (Day 32) but low MRD (<0.001) at second time point (week 10-12)
Final Risk Group assigned at end of Consolidation IA. Subsequent therapy as follows:
CNS phase (vincristine, dexamethasone, mercaptopurine, pegaspargase [by randomization or direct assignment], IT chemotherapy); Consolidation II (vincristine, dexamethasone, mercaptopurine, doxorubicin + dexrazoxane, pegaspargase [by randomization or direct assignment], IT chemotherapy); Continuation (vincristine, dexamethasone, mercaptopurine, methotrexate, IT chemotherapy).
All treatment completed 24 months from date of complete remission.
Group IX: Direct AssignmentExperimental Treatment2 Interventions
All VHR patients, and any Final LR, IR, HR patients who decline randomization: Assigned to receive standard dosing of pegaspargase (15 doses of pegaspargase every 2-weeks at standard fixed-dose; 2500 IU/m2/dose).
Group X: Fixed Dose PegaspargaseActive Control2 Interventions
Final LR, IR, HR patients who consent to randomization and are assigned to receive 15 doses of pegaspargase every 2-weeks at standard fixed-dose (2500 IU/m2/dose).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MERCAPTOPURINE
2015
Completed Phase 4
~220
Doxorubicin
2012
Completed Phase 3
~7940
METHOTREXATE
2015
Completed Phase 4
~30
Vincristine
2003
Completed Phase 4
~2910
Dexrazoxane
2016
Completed Phase 2
~80
DEXAMETHASONE
2013
Completed Phase 3
~100
Pegaspargase
2005
Completed Phase 3
~9010
Erwinia asparaginase
2012
Completed Phase 2
~30
Cyclophosphamide
1995
Completed Phase 3
~3780
Find a Location
Who is running the clinical trial?
Dana-Farber Cancer InstituteLead Sponsor
1,078 Previous Clinical Trials
340,312 Total Patients Enrolled
ServierIndustry Sponsor
49 Previous Clinical Trials
42,896 Total Patients Enrolled
Lewis Silveman, MDPrincipal InvestigatorDana-Farber Cancer Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have received a dose of cytarabine in my spine before joining this study.I am between 1 and 21 years old.My leukemia is classified as mixed phenotype or ambiguous lineage.My leukemia type was confirmed with a blood test.I have only taken corticosteroids for up to 7 days in the last month.I do not have any severe illnesses or conditions that could interfere with the study.I am not pregnant or breastfeeding.I had cancer before, but it was treated with surgery alone over 5 years ago.I have not received any treatments except for allowed ones.I have had emergency radiation for a critical mass before signing up.I have been treated with cancer drugs for any condition.I have not been on corticosteroids for more than 7 days in the last month or more than 28 days in the last 6 months.I am HIV-positive.I have not had chemotherapy or radiotherapy for another cancer.My leukemia is a type called Burkitt's with specific genetic features.I have been diagnosed with acute lymphoblastic leukemia.
Research Study Groups:
This trial has the following groups:- Group 1: Direct Assignment
- Group 2: Final High Risk (Final HR)
- Group 3: Final Intermediate Risk (Final IR)
- Group 4: Final Very High Risk (Final VHR)
- Group 5: Reduced Dose (PK-Adjusted) Pegaspargase
- Group 6: Initial Low Risk (Initial LR)
- Group 7: Initial High Risk (Initial HR)
- Group 8: Initial Very High Risk (Initial VHR)
- Group 9: Final Low Risk (Final LR)
- Group 10: Fixed Dose Pegaspargase
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has Pegaspargase been cleared by the FDA?
"Pegaspargase has received a score of 3 from our analysts at Power. This is due to the fact that it is a phase 3 trial, where there is some evidence of efficacy in addition to multiple rounds of data affirming its safety."
Answered by AI
What is the typical application of Pegaspargase?
"Pegaspargase is not only effective in treating macular edema, but also pheochromocytomas, iritis, and ulcerative colitis."
Answered by AI
Do a lot of hospitals in America participate in this clinical trial?
"At the moment, there are 9 hospitals where this trial is taking place. They can be found in Providence, Bronx and Montreal as well as 6 other cities. If you want to make enrolling easier on yourself, try and pick a location that is close to where you live."
Answered by AI
Does this research study have an age limit?
"The age requirement to participate in this trial is between 1 and 21 years old."
Answered by AI
How can I join this clinical research project?
"This clinical trial is admitting 560 people, between the ages of 1 Year and 21 who have leukemia, lymphocytic, acute, l1. It is important that patients also meet the following criteria: Confirmed diagnosis of acute lymphoblastic leukemia. Diagnosis should be made by bone marrow aspirate or biopsy demonstrating ≥ 25% involvement by lymphoblasts, with flow cytometry or immunohistochemistry confirming B-precursor or T-ALL phenotype., -- For patients with circulating blasts in the peripheral blood, flow cytometry confirmation of B-ALL or T-ALL phenotype is sufficient for registration onto the study."
Answered by AI
What is the existing research on Pegaspargase's efficacy?
"Pegaspargase was first studied in 1995 at the National Institutes of Health Clinical Center. There have been 3899 completed trials and there are currently 2210 active trials. Many of these active trials are taking place in Providence, Rhode island."
Answered by AI
Are there any vacancies left in this research project?
"This particular clinical trial, which was posted on March 3rd 2017 and last updated November 10th 2022, is not currently enrolling patients. There are 3757 other trials that are open for enrollment across the globe."
Answered by AI
How many people are being included in this clinical research project?
"Unfortunately, this trial is not currently looking for patients. The first posting was on March 3rd, 2017 and the last edit was November 10th, 2022. However, there are 1547 other trials recruiting leukemia patients and 2210 trials recruiting Pegaspargase patients."
Answered by AI
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