Phase 2 Lymphoma Trial, Recruiting NCT06317662 Sponsor: National Cancer Institute (NCI) Condition: Lymphoma
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Phase 2 Lymphoma Trial, Recruiting

NCT06317662
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You must already be enrolled in a related screening study called APEC14B1 and have completed the initial eligibility screening before joining this trial
  • The child must be a baby aged 365 days (1 year) or younger at the time of diagnosis, and must have been born after at least 36 weeks of pregnancy
  • The child must have been newly diagnosed with a specific type of blood cancer called B-cell acute lymphoblastic leukemia (B-ALL), or a related condition called acute leukemia of ambiguous lineage (ALAL), where at least half of the leukemia cells are of the B-cell type
  • The leukemia cells must show a specific marker called CD19 on their surface
  • The child's parent or legal guardian must sign a written consent form agreeing to take part
  • All required legal and regulatory rules for medical studies must be met

Who may not be able to join:

  • Children who have Down Syndrome
  • Children whose B-ALL developed as a result of chemotherapy treatment for a previous cancer
  • Children who have already received chemotherapy drugs for this or any previous cancer diagnosis — with a few specific exceptions:
    • Short courses (3 days or less) of certain steroids (prednisone, prednisolone, or methylprednisolone) given in the 7 days before enrollment are allowed; inhaled or skin-applied steroids do not count
    • A steroid called dexamethasone is generally not allowed within 28 days before starting treatment, except for a single dose used around a sedation procedure to protect the airway
    • A single dose of certain chemotherapy drugs given directly into the spinal fluid (cytarabine or methotrexate) within 7 days before enrollment is allowed
    • Up to 3 days of a drug called hydroxyurea given in the 7 days before enrollment is allowed

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 5 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

GP referral letter

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Trial details

Status
Recruiting
Phase
Phase 2
Registry
ClinicalTrials.gov
Start date
5 June 2025
Est. completion
31 December 2028

Where this trial is recruiting

Puerto Rico 🇺🇸 United States

Primary endpoints

Incidence of dose-limiting toxicities (DLTs) (safety phase); Incidence of DLTs (expansion phase); Minimal residual disease (MRD)-negative remission rate

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 5 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov