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Clinical trials
- Participate in a clinical trial
- For medical professionals
- Active clinical trials for pediatric cancers
- CAR-20/19-T cells in pediatric and young adult patients with relapsed/refractory B Cell Acute Lymphoblastic Leukemia (CAR-20/19-T) phase 1 clinical trial
- Unrelated and partially matched related donor peripheral stem cell transplantation for patients with hematologic malignancies clinical trial
- Early stage research
Active clinical trials
Cancer Clinical Trials - COG-AALL1731
Protocol Summary
- Protocol No
- COG-AALL1731
- Principal Investigator
- Michael Burke
- Phase
- III
- Title
- A Phase 3 Trial Investigating Blinatumomab (NSC# 765986) in Combination with Chemotherapy in Patients with Newly Diagnosed Standard Risk or Down Syndrome B-Lymphoblastic Leukemia (B-ALL) and the Treatment of Patients with Localized B-Lymphoblastic Lymphoma (B-LLy)
- Associated Disease(s)
-
Acute Lymphoblastic Leukemia (ALL)
- Description (Summary)
- For patients with B-cell Leukemia.
The purpose of Part I of this study is to collect information on the leukemia and how it responds to the treatment. To enroll on this study, you need to first sign a consent form for the study APEC14B1 (Project:EveryChild). This other study will be explained to you in a different consent.
We will collect blood tests and bone marrow tests to see how fast the leukemia is responding to the treatment. This is done by a test called minimal residual disease (MRD). The MRD results will also be used to determine the risk group of your leukemia at the end of Induction. Your doctor will explain the results of the test. Your doctor will explain what your risk group means. The MRD test will also help doctors understand why some chemotherapy drugs are not as good for some patients. MRD testing is explained in detail in the "Research Study Tests and Procedures"; section.
The overall goal of Part I of this study is to collect information about your leukemia and your response to the first phase of treatment, called Induction.
You may be offered the chance to take part in Part II of this study after Induction once your B-ALL risk group is known. Depending on your risk group, there is a chance that you may be randomized to receive the investigational medicine, blinatumomab plus standard treatment during Part II. Randomization means you will have an equal chance of receiving or not receiving blinatumomab.
In Part II of this study, all patients will be treated with the same length of therapy for boys and girls. The standard duration of treatment in COG ALL trials has been gender-based, with girls receiving 2 years and boys receiving 3 years of treatment after the start of Interim Maintenance I. However, recent analyses of past studies have shown that the additional year of therapy for boys may not lead to improvements in their outcome with our modern therapies. In addition, other groups in other parts of the country and the world currently do not give additional therapy to boys. We hope that eliminating the additional year of therapy for boys on this study will result in fewer long term side effects. We will be monitoring boys closely on this study to see if they have higher rates of the leukemia returning compared to boys previously treated with three years of therapy.
For patients with B-cell Lymphoma
Historically, localized B-LLy was treated similarly to “high risk” B lymphoblastic leukemia (B-ALL) with good results. B-ALL is a kind of cancer that occurs in the bone marrow, and is more common than B-LLy. The treatment used for B-LLy subjects on this study is less intense in some ways than standard treatment for B-LLy and is similar to that used currently in COG centers for children and young adults with “standard risk” B-ALL. We want to see if using the same kind of therapy used to treat “standard risk” B-ALL results in the same good outcomes while decreasing side effects.
The overall goal of this study is to see if children with localized B-LLy receiving “standard risk” B-ALL therapy maintain good treatment outcomes
- Participating Institutions
- Childrens Hospital of Wisconsin
- ClinicalTrials.gov
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Why participate in clinical trials?
"The steady improvement in survival for children with cancer is a direct result of their enrollment onto clinical trials; without which we would remain decades behind in terms of scientific advances in pediatric cancer." ~Michael J. Burke, MD