Adding daratumumab to chemotherapy for newly diagnosed T-cell leukemia or lymphoma
Treatments studied
Part of Blood & lymphatic, Cancer, Immune system & allergy clinical trials.
This trial tests whether adding the drug daratumumab to usual chemotherapy helps children and young adults with T-cell acute lymphoblastic leukemia (T-ALL) or T-cell lymphoblastic lymphoma (T-LL). The goal is to see if the combination improves outcomes without increasing side effects.
Summary written for real people, not researchers, by Clin2.
Who can take part
- You must be older than 365 days (1 year) and younger than 21 years at diagnosis.
- You must have newly diagnosed T-ALL (with more than 25% leukemia cells in the bone marrow) or T-LL (stages II-IV) that has not been treated with chemotherapy before.
- You can have had a short course of steroids (like prednisone) for up to 5 days, or a single dose of dexamethasone for airway swelling, without affecting eligibility.
- You cannot have Down syndrome, Charcot-Marie-Tooth disease, or severe persistent asthma in the last two years.
- If you are female and able to have children, you must have a negative pregnancy test and agree not to breastfeed during the study.
- If you are sexually active and could cause pregnancy, you must agree to use effective birth control during the study.
- You must not have uncontrolled seizures. A controlled seizure disorder is okay if symptoms have been stable or better for the past 3 months without seizure medication, or on a stable or decreasing dose.
- You must not have HIV with detectable viral load, untreated chronic hepatitis B, or active hepatitis C (unless cured or on treatment with undetectable viral load).
- You must have adequate liver function (ALT and bilirubin within limits) unless the liver problems are due to the cancer.
- You must also be enrolled on the APEC14B1 study (a screening study) and agree to participate in the AALL2331 trial.
Quick eligibility check
Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.
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