Pegaspargase for Acute Lymphoblastic Leukemia (ALL)

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Wesley Medical Center, Wichita, KS
Acute Lymphoblastic Leukemia (ALL)+5 More
Pegaspargase - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether combination chemotherapy with blinatumomab is more effective than chemotherapy alone in treating patients with newly diagnosed breakpoint cluster region (BCR)-c-abl oncogene 1, non-receptor tyrosine kinase

See full description

Eligible Conditions

  • Acute Lymphoblastic Leukemia (ALL)
  • B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative

Treatment Effectiveness

Effectiveness Progress

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

Other trials for Acute Lymphoblastic Leukemia (ALL)

Study Objectives

This trial is evaluating whether Pegaspargase will improve 1 primary outcome, 3 secondary outcomes, and 1 other outcome in patients with Acute Lymphoblastic Leukemia (ALL). Measurement will happen over the course of Up to 32 weeks.

Year 10
Overall survival
Year 10
Relapse-free survival
Up to 10 years
Incidence of adverse events
Up to 2 years
Identification and characterization of the BCR/ABL1-like phenotype
Up to 32 weeks
Minimal residual disease (MRD) status

Trial Safety

Safety Progress

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

Other trials for Acute Lymphoblastic Leukemia (ALL)

Trial Design

2 Treatment Groups

Arm II (chemotherapy)
1 of 2
Arm I (blinatumomab, chemotherapy)
1 of 2
Active Control
Experimental Treatment

This trial requires 488 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.

Arm I (blinatumomab, chemotherapy)See Detailed Description
Arm II (chemotherapy)See Detailed Description
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pegaspargase
FDA approved
Rituximab
FDA approved
Daunorubicin
FDA approved
Daunorubicin
FDA approved
Cortisone
Not yet FDA approved
Cytarabine
FDA approved
Dexamethasone
FDA approved
Etoposide
FDA approved
Mercaptopurine
FDA approved
Allogeneic Hematopoietic Stem Cell Transplantation
2015
Completed Phase 2
~1230
Vincristine
FDA approved
Methopterin
Not yet FDA approved
Vincristine
FDA approved
Muromonab
FDA approved
Cyclophosphamide
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 10 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 10 years for reporting.

Closest Location

Wesley Medical Center - Wichita, KS

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received newly diagnosed for Acute Lymphoblastic Leukemia (ALL) or one of the other 5 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Please pre-register for the conference show original
if a peripheral blood sample can be obtained for FISH testing Cytogenetic analysis is done on a diagnostic bone marrow sample or, if there are enough circulating blasts in the blood, on a peripheral blood sample show original
It is essential that a sample containing sufficient blast cells be submitted to the ECOG-ACRIN LTRL at baseline so that subsequent bone marrow assessments of MRD can be done; in addition to allowing the LTRL to confirm eligibility based on blast cell immunophenotype and BCR/ABL status, it is also imperative that an adequate number of blasts be banked for analysis by DRS Mullighan/Willman show original
for ALL-B A new diagnosis of B lineage ALL must be made upon bone marrow or peripheral blood immunophenotyping; cases with myeloid antigen expression, but unequivocal lymphoid immunophenotype, are eligible for ALL-B. show original
The Philadelphia chromosome must be established by conventional cytogenetics, fluorescence in situ hybridization (FISH) and/or polymerase chain reaction (PCR) show original
The patient's serum direct bilirubin should be less than 2 mg/dL, and their serum total bilirubin should be less than 3 (obtained less than 48 hours prior to registration) show original
For registration, the patient's serum creatinine level must be less than 2 mg/dl and it must have been obtained less than 48 hours prior to registration show original
Diagnostic bone marrow and peripheral blood specimens must be submitted for immunophenotyping and selected molecular testing, and the establishment of BCR/ABL status; testing will be performed by the Eastern Cooperative Oncology Group (ECOG)-American College of Radiation Imaging Network (ACRIN) Leukemia Translational Research Laboratory (LTRL) and reported to the institution
in the study Hydroxyurea can be given for up to 5 days prior to the initiation of therapy in the study in order to control the leukocyte count and/or other symptoms or signs show original
In order to be eligible for induction into the Army, you must meet the following step 1 criteria: -You must be a U.S show original

Patient Q&A Section

Can leukemia, lymphocytic, acute, l1 be cured?

"As with lung cancer, outcomes vary with stage and type of leukemia. While most adult cases of both B-cell and T-cell acute lymphoblastic leukemias may be curable, this is not the case in acute myelogenous leukemia (AML). With AML, the prognosis is typically poor with median survival only 4 to 8 months. However, this depends almost entirely on the presence or absence of remission at the time of diagnosis, which, again, varies, especially among those with cytogenetic abnormalities associated with long-term survival. Because of the high rate of relapse, cure is practically impossible with AML." - Anonymous Online Contributor

Unverified Answer

What is leukemia, lymphocytic, acute, l1?

"Acute myeloid leukemia has five-year survival rates of 30-50% and children with ALL have five-year survival rates of 45-50% at presentation. Five-year survival for patients with acute lymphocytic leukemia remains above 50%. Low-risk, elderly patients with ALL have five-year survival rates of about 75%. Patients with acute lymphoblastic leucemia have about 25-50% five-year survival rate. Patients who are in remission at diagnosis and those in complete complete remission have longer survival times." - Anonymous Online Contributor

Unverified Answer

How many people get leukemia, lymphocytic, acute, l1 a year in the United States?

"The American Cancer Society estimates 21,470 new cases of acute lymphoid leukemia, chronic lymphocytic leukemia, lymphoid, acute, l1 would be diagnosed in 2019 in the United States." - Anonymous Online Contributor

Unverified Answer

What are the signs of leukemia, lymphocytic, acute, l1?

"Leukopenia is an important sign of leukemia, lymphocytic, acute, l1. Low numbers of white blood cells occur in approximately 5% of new lymphocytic, acute leukemia, l1 cases and about 20% of leukemia, acute, l1 cases. White blood cell count values below normal are referred to as aplastic anemia, and that is the hallmark sign of leukemia, lymphocytic, acute, l1.\n" - Anonymous Online Contributor

Unverified Answer

What causes leukemia, lymphocytic, acute, l1?

"Leukemia, lymphocytic, acute, L1 is a disease of the blood and bones. It is very likely that leukemia and lymphocytic, acute, L1 share many of the same causes. This is the first study to suggest that leukemia and lymphocytic, acute, L1 may share a common etiology." - Anonymous Online Contributor

Unverified Answer

What are common treatments for leukemia, lymphocytic, acute, l1?

"Treatments for both acute and chronic leukemias have developed tremendously in modern years. It is important to understand the types of chemotherapeutic agent and how they work to manage the disease and minimize its effects. The management and treatment of leukemia remain very complicated." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving pegaspargase?

"The FDA stated some data regarding the safety and efficacy of pegaspargase should not be published in order to prevent bias in future work; however, the authors' conclusions were unaffected." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in pegaspargase for therapeutic use?

"Pegaspargase, the first synthetic, recombinantly engineered peptide, metalloproteinase was approved in 2005. Since then, pegasys(R)arg has been available for therapeutic use mainly with myelodysplastic and leukemic syndromes. In addition to its already very good tolerability, the main advantage of pegasys(R)arg is that it can be injected only once a week, in one central vial. As a result, less blood product is transfused and less treatment-related pain, as well as significant cost savings are possible. As pegaspargase has already shown its efficacy, our hope is to use it more and more in the future." - Anonymous Online Contributor

Unverified Answer

Has pegaspargase proven to be more effective than a placebo?

"Pegaspargase 3 mg/m2 was associated with a significant increase in progression-free and total survival. Results from a recent paper suggested that patients with advanced Hodgkin's disease should be selected for this study. Results from a recent paper represents an active comparison between pargasinum and a placebo with a very low dropout rate and no differences of toxicity observed." - Anonymous Online Contributor

Unverified Answer

What are the chances of developing leukemia, lymphocytic, acute, l1?

"Acute lymphoblastic leukemia and lymphocytic leukemia are both equally likely to occur in children as both in adults, except with age group 5–9 years where the occurrence of both are significantly more uncommon. Older adults are less likely to develop lymphocytic leukemia, but are more likely to develop acute leukemia than their younger counterparts." - Anonymous Online Contributor

Unverified Answer

How does pegaspargase work?

"The treatment using pegaspargase is safe with a minimal toxicity. This helps the patients get healed faster, lowers the disease free period, and provides better quality of life to the patients." - Anonymous Online Contributor

Unverified Answer

How quickly does leukemia, lymphocytic, acute, l1 spread?

"Survival of patients with leukemia is dependent on the speed in which they have their most severe illnesses and receive treatment. These illnesses include fever, weight loss, and high fever and have a high mortality ratio relative to the cancer itself. Survival is decreased for those patients who receive treatment more early, have a shorter disease duration, and have a longer interval between symptoms." - 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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