Study on Chemotherapy Treatment for Adolescents and Young Adults with Philadelphia Chromosome-Negative Acute Lymphoblastic Leukemia
Sponsor: Dana-Farber Cancer Institute
ClinicalTrials ID:NCT07227584
This clinical trial is evaluating a chemotherapy treatment plan for adolescents and young adults newly diagnosed with a type of leukemia called Philadelphia chromosome-negative acute lymphoblastic leukemia (ALL). The study involves several drugs, including blinatumomab, cyclophosphamide, and others, to assess their safety and effectiveness.
Patient Parameters
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Program Overview
The purpose of this study is to test a chemotherapy treatment plan for adolescents and young adults who have been newly diagnosed with Philadelphia chromosome-negative acute lymphoblastic leukemia (ALL). The study will use a combination of drugs, including blinatumomab, cyclophosphamide, and others, to see how well they work together in treating this type of leukemia. All the drugs used in this study are approved by the FDA, but researchers want to learn more about how safe and effective they are when used in this specific combination for young patients.
Description
This is a Phase 2 study where researchers are testing a chemotherapy treatment plan for young people with a specific type of leukemia called Philadelphia chromosome-negative acute lymphoblastic leukemia (ALL). The study will involve several drugs, including blinatumomab, cyclophosphamide, and others, to see how well they work together in treating this type of leukemia. The study will include screening for eligibility, regular clinic visits, and various tests such as blood and urine tests, X-rays, and heart function tests. Participants will be involved in the study for about 10 years, with 2 years of treatment and 8 years of follow-up. Around 67 people are expected to participate in this study.
Eligibility Criteria
Inclusion Criteria
- Must have a confirmed diagnosis of Philadelphia chromosome-negative acute lymphoblastic leukemia (ALL).
- Diagnosis should show at least 25% involvement by lymphoblasts, confirmed by specific tests.
- Participants with certain types of lymphoblastic lymphoma are eligible.
- Participants with leukemia affecting the central nervous system are eligible.
- Allowed prior treatments include corticosteroids, hydroxyurea, and certain chemotherapy or radiation therapies.
- Must be between 18 and 50 years old.
- Must have a direct bilirubin level below 1.4 mg/dL.
- Must agree to use effective birth control during the study and for a period after.
- Must be able to understand and sign a consent form.
Exclusion Criteria
- Cannot have Philadelphia chromosome-positive leukemia.
- Cannot have mature B-cell (Burkitt's) ALL or acute undifferentiated leukemia.
- Cannot be receiving other investigational treatments for this condition.
- Cannot have uncontrolled illnesses or conditions that interfere with study participation.
- Cannot be sexually active without using effective contraception.
- Pregnant women cannot participate due to potential risks to the fetus. Breastfeeding should be stopped if participating.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Dana Farber Cancer Institute | 02215 | Boston | Massachusetts |
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