Study on Ixazomib with Chemotherapy for Children with Relapsed or Hard-to-Treat Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma
Sponsor: Therapeutic Advances in Childhood Leukemia Consortium
ClinicalTrials ID:NCT03817320
This clinical trial is testing a new treatment using the drug Ixazomib combined with chemotherapy to see if it can help children with relapsed or difficult-to-treat acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LLy).
Patient Parameters
| Parameter | Options |
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Program Overview
The study aims to find the safest dose of Ixazomib when taken by mouth and to see how well it works with chemotherapy in children with relapsed ALL and LLy. The trial will first determine the best dose and then test its effectiveness in a small group of patients. If successful, this treatment could be used in future pediatric cancer treatments.
Description
This study is divided into two phases. In Phase 1, researchers will determine the safest dose of Ixazomib when taken by mouth. In Phase 2, they will test how effective this dose is when combined with chemotherapy in children with relapsed acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LLy). The goal is to find a safe and effective treatment that could be used in future cancer therapies for children.
Participants will receive Ixazomib along with chemotherapy drugs Vincristine, Dexamethasone, Asparaginase, and Doxorubicin. The study will monitor the safety and effectiveness of this combination to see if it can help control the cancer. If the treatment shows promise, it may be included in future treatment plans for children with these types of cancer.
Eligibility Criteria
Inclusion Criteria
- Must be 21 years old or younger.
- Have a diagnosis of relapsed or hard-to-treat acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LLy).
- Must have a certain level of cancer cells or measurable disease.
- Be in relatively good health with a performance level of at least 50%.
- Have tried previous treatments without success.
- Must have recovered from any previous cancer treatments.
- Have adequate kidney and liver function.
- Have good heart function.
- Women of childbearing age must have a negative pregnancy test and agree not to breastfeed.
- Agree to use effective birth control during and after the study.
- Must understand and agree to the study requirements and sign a consent form.
Exclusion Criteria
- Have cancer only in the brain or testicles.
- Have severe nerve damage.
- Have allergies to any study drugs, except for specific substitutions.
- Have an active infection that is not improving.
- Plan to receive other cancer treatments during the study.
- Have other serious health issues that could affect participation.
- Have certain genetic conditions like Fanconi anemia.
- Have had too much exposure to certain chemotherapy drugs.
- Are taking other investigational drugs or certain medications that affect the liver.
- Are receiving treatment for specific types of leukemia with certain medications.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Children's Hospital Los Angeles | 90027 | Los Angeles | California |
| Children's Hospital Orange County | 92868 | Orange | California |
| Children's National Medical Center | 20010 | Washington D.C. | District of Columbia |
| University of Miami | 33136 | Miami | Florida |
| Children's Healthcare of Atlanta | 30322 | Atlanta | Georgia |
| C.S. Mott Children's Hospital | 48109 | Ann Arbor | Michigan |
| Children's Hospital and Clinics of Minnesota | 55404 | Minneapolis | Minnesota |
| Columbia University Medical Center | 10032 | New York | New York |
| Levine Cancer Institute | 28204 | Charlotte | North Carolina |
| University Hospitals Seidman Cancer Center | 44106 | Cleveland | Ohio |
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