Pegaspargase for Leukemia, Lymphocytic, Acute, L1

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Montefiore Medical Center, Bronx, NY
Leukemia, Lymphocytic, Acute, L1+3 More
Pegaspargase - Drug
Eligibility
< 65
All Sexes
Eligible conditions
Select

Study Summary

Treatment of Newly Diagnosed Acute Lymphoblastic Leukemia in Children and Adolescents

See full description

Eligible Conditions

  • Leukemia, Lymphocytic, Acute, L1
  • Leukemia, Lymphoblastic, Acute, Pediatric

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Other trials for Leukemia, Lymphocytic, Acute, L1

Study Objectives

This trial is evaluating whether Pegaspargase will improve 2 primary outcomes and 4 secondary outcomes in patients with Leukemia, Lymphocytic, Acute, L1. Measurement will happen over the course of From randomization or direct assignment (for participants who achieved a complete remission and were assigned a final risk group) to the time of relapse, death, or second malignancy, whichever came first, assessed up to 60 months..

Year 5
Complete Remission Rate
Year 5
Nadir Serum Asparaginase Activity (NSAA)
Year 5
Non-allergic Asparaginase Toxicity
Month 60
Disease Free Survival
Month 60
Overall Survival
Month 60
Event-Free Survival

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Leukemia, Lymphocytic, Acute, L1

Trial Design

2 Treatment Groups

Fixed Dose Pegaspargase
1 of 2
Reduced Dose (PK-Adjusted) Pegaspargase
1 of 2
Active Control
Experimental Treatment

This trial requires 560 total participants across 2 different treatment groups

This trial involves 2 different treatments. Pegaspargase is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 3 and have had some early promising results.

Reduced Dose (PK-Adjusted) PegaspargaseFinal 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.
Fixed Dose PegaspargaseFinal 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
Pegaspargase
FDA approved
Asparaginase Erwinia chrysanthemi
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 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)
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 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) for reporting.

Who is running the study

Principal Investigator
L. B. S. M.
Lewis B. Silverman M.D., Principal Investigator
Dana-Farber Cancer Institute

Closest Location

Montefiore Medical Center - Bronx, NY

Eligibility Criteria

This trial is for patients born any sex aged 65 and younger. You must have received newly diagnosed for Leukemia, Lymphocytic, Acute, L1 or one of the other 3 conditions listed above. There are 9 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
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. Bone marrow aspirate and/or biopsy should be performed as soon as feasible, preferably prior to the initiation of any therapy.
Corticosteroids: Short courses of corticosteroid (defined as ≤ 7 days of corticosteroids within the 4-weeks preceding registration) are allowed prior to registration.
--- Participants who have been on corticosteroids chronically (defined as more than 7 days of corticosteroids within the 4-weeks preceding registration or more than 28 days of corticosteroids over the preceding 6 months) are not eligible.
IT cytarabine: A single dose of intrathecal cytarabine (at the time of the diagnostic lumbar puncture) is allowed prior to registration. If patient has received IT cytarabine prior to registration, Day 1 IT cytarabine should not be administered.
Emergent Radiation Therapy: Emergent radiation to the mediastinum or other life-threatening masses is allowed prior to registration.
Age: 365 days to < 22 years
Direct bilirubin < 1.4 mg/dL (23.9 micromoles/L).
Ability of parent or guardian to understand and the willingness to sign a written informed consent document.

Patient Q&A Section

What are the chances of developing leukemia?

"Almost 20% of healthy adults are expected to develop leukemia at some point in their life. The chance of developing leukemia is higher among adolescents who develop hematologic disorders and the elderly." - Anonymous Online Contributor

Unverified Answer

How quickly does leukemia spread?

"Within 3 months, leukemia had spread in 15.4% of patients. Patients with a complete remission, in contrast, had no sign of leukemia spread in either bone marrow or peripheral blood after a similar length of time. Thus, after relapse, bone marrow or peripheral blood should be tested for leukemia at the same times as bone marrow and peripheral blood in patients with complete remission." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of pegaspargase?

"pegaspargase treatment is associated with common side effects including febrile neutropenia, hepatotoxicity, pancreatitis, and allergic reactions. However, these side effects rarely impede the therapy and are manageable in most cases, but when they do, patients should be hospitalized for evaluation and treatment. In this way, they can be prevented and managed." - Anonymous Online Contributor

Unverified Answer

What causes leukemia?

"Results from a recent paper suggests that genetic mutations resulting in an increased number of aberrant cells may occur frequently among people who develop leukemia. A second mechanism, involving the production of a single abnormal cell, may increase the risk." - Anonymous Online Contributor

Unverified Answer

What is leukemia?

"answer: The study suggests the relevance of teaching medical students the concepts and terminology used in the context of hematologic malignancies, in order to enable students to make better decisions." - Anonymous Online Contributor

Unverified Answer

Can leukemia be cured?

"The cure for leukemia remains elusive. Current treatment options (imatinib, fludarabine/cyclophosphamide/melphalan plus filgrastim/rituximab) have provided durable remissions in the order of many years in a substantial number of patients. However, the cure in patients is not always long-lasting, with about one third of relapsed/refractory cases dying quickly and some patients continuing to deteriorate despite new treatment. Further, more effective treatments, particularly in newly-diagnosed forms of leukemias, as well as for the more aggressive variants of B-CLL, CLL, and hairy cell leukemia, are needed urgently." - Anonymous Online Contributor

Unverified Answer

What are the signs of leukemia?

"Signs of leukemia involve the gastrointestinal tract and the skin. Signs of leukemia are often associated with malaise, anemia, weight loss, and fatigue. Signs of leukemia may be present for as long as 4 weeks." - Anonymous Online Contributor

Unverified Answer

How many people get leukemia a year in the United States?

"Approximately 22,000 people per year are diagnosed with leukemia, which makes up 8.7% of American adults. In adults, leukemia occurs most commonly in the developing world. Lymphoproliferative disorders such as lymphoma and multiple myeloma are more common in men than in women. Most frequently, leukemia occurs in older children; however, leukemia of childhood has a skewed age incidence (mean age of diagnosis: 6.8 yr) compared with newly diagnosed leukemia in adults (mean age: 61 yr)." - Anonymous Online Contributor

Unverified Answer

What are common treatments for leukemia?

"It is imperative that healthcare professionals remember to listen to patients and tailor treatment to their particular needs based on a thorough medical history as well as objective laboratory measurements of the patient to ensure that the best available treatment is delivered to the cancer patient. This is especially important to remember when dealing with cancer patients who are children and adolescents. They are still developing with each growth doubling and in some cases may be in danger of developing the more serious leukemia of childhood." - Anonymous Online Contributor

Unverified Answer

Does leukemia run in families?

"Although the prevalence of hematological malignancies is not significantly correlated with a family history of cancer, the risk in the offspring is increased to the same extent as seen in other cancers. Therefore, the family history does not suffice as a screening tool in the diagnosis of a possible hereditary disease." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving pegaspargase?

"Results from a recent clinical trial of this trial suggest that PEGylated asparaginase is safe in patients with advanced childhood leukemia. Furthermore, this study supports ongoing assessment of pegaspargase as an intravenous chemotherapy agent in pediatric patients." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets leukemia?

"In Canada the average age of diagnosis of CML appears to be around 55.5 years, however studies done in England and the US show it is more likely to be earlier. A reason would be if more common in the Western world, but its hard to say for sure but the average age is probably in the early 50s across European nations." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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