Not Yet RecruitingPhase 2/3

Testing the Addition of Daratumumab to Chemotherapy for Treating Patients With Newly-Diagnosed T-Cell Lymphoblastic Leukemia (T-ALL) and T-Cell Lymphoblastic Lymphoma (T-LL)

1,708 participantsStarted 2026-08-28

Plain-language summary

This phase II/III trial tests the addition of daratumumab to chemotherapy for treating patients with newly-diagnosed T-ALL and T-LL. Daratumumab is in a class of medications called monoclonal antibodies. It binds to a protein called CD38, which is found on some types of immune cells and cancer cells. Daratumumab may block CD38 and help the immune system kill cancer cells. Chemotherapy drugs work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy with daratumumab may kill more cancer cells.

Who can participate

Age range

365 Days – 21 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * All patients must be enrolled on APEC14B1 and consented to eligibility screening (part A) prior to treatment and enrolled on AALL2331. * Patients must be \> 365 days and \< 21 years of age at the time of diagnosis. * \* Newly diagnosed T-cell acute lymphoblastic leukemia (T-ALL) or T-lineage lymphoblastic lymphoma (T-LL) stages II-IV. * Note: A diagnosis of T-ALL is established when leukemic blasts lack myeloperoxidase or evidence of B-lineage derivation (CD19/CD22/CD20), and express either surface or cytoplasmic CD3 or two or more of the antigens CD8, CD7, CD5, CD4, CD2 or CD1a, and are present either in peripheral blood or \> 25% in the bone marrow. If surface CD3 is expressed on all leukemic cells, additional markers of immaturity, including TdT, CD34 or CD99 will be assessed for expression. Cases with uncertain expression will receive additional review within the appropriate Children's Oncology Group (COG) reference laboratory. * For T-LL patients with tissue available for flow cytometry, the criterion for diagnosis should be analogous to T-ALL. For tissue processed by other means (i.e. paraffin blocks), the methodology and criteria for immunophenotypic analysis to establish the diagnosis of T-LL defined by the submitting institution will be accepted. Exclusion Criteria: * Diagnosis of Down syndrome (trisomy 21). * Patients with known Charcot-Marie-Tooth disease. * \* Patients must not have received any cytotoxic chemotherapy for either the c…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial is Phase 2/3 and hasn't started recruiting yet — does that mean there's still a lot unknown about how safe daratumumab is when combined with standard chemotherapy for T-ALL or T-LL, and should I consider starting with proven standard treatment now rather than waiting for this trial to open?
2The trial is measuring event-free survival as its main goal — can you explain what 'event-free survival' means in my specific situation and how adding daratumumab to chemotherapy might or might not improve that compared to chemotherapy alone?
3Since this trial covers both T-cell leukemia (T-ALL) and T-cell lymphoma (T-LL), and my diagnosis is one of those — does my specific diagnosis and stage make me a potentially good or poor fit to discuss with the research team once enrollment opens?
4Daratumumab is a drug already used in other blood cancers like myeloma — are there known side effects or risks from daratumumab that I should weigh against any potential benefit before deciding whether this trial is worth pursuing when it becomes available?
5Given that this trial is not yet recruiting, how long might it be before it opens, and is waiting for it a realistic option given how quickly my condition may need treatment?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Event-free survival (EFS) in patients with newly diagnosed T-cell lymphoblastic leukemia (T-ALL)

Timeframe: From date of randomization (randomization conducted at the end of induction [EOI]) to date of first event (consolidation failure, interim maintenance failure, relapse, secondary malignant neoplasm [SMN], death from any cause), assessed up to 4 years

EFS in patients with newly diagnosed T-cell lymphoblastic lymphoma (T-LL)

Timeframe: From date of randomization (randomization conducted at the EOI) to date of first event (consolidation failure, relapse, progressive disease, SMN, death from any cause), assessed up to 4 years

Trial details

NCT IDNCT07072585

SponsorChildren's Oncology Group

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion2035-09-01

View on ClinicalTrials.gov More Stage II T Lymphoblastic Leukemia/Lymphoma trials