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)

Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age365-21
SponsorChildren's Oncology Group

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

Diagnosis of Down syndrome (trisomy 21).

Patients with known Charcot-Marie-Tooth disease.

Steroid pretreatment: Prednisone or methylprednisolone for ≤ 120 hours (5 days) in the 7 days prior to initiating induction chemotherapy or for ≤ 336 hours (14 days) in the 28 days prior to initiation of protocol therapy does not affect eligibility.

Intrathecal cytarabine; or

Trial design

Treatments tested in this trial

  • Biopsy Procedure
  • Biospecimen Collection
  • Bone Marrow Aspiration
  • Bone Marrow Biopsy
  • Bone Scan
  • Bortezomib
  • Calaspargase Pegol
  • Computed Tomography
  • Cyclophosphamide
  • Cytarabine
  • Daratumumab
  • Daunorubicin Hydrochloride
  • Dexamethasone
  • Doxorubicin Hydrochloride
  • Echocardiography Test
  • Lumbar Puncture
  • Magnetic Resonance Imaging
  • Mercaptopurine Oral Suspension
  • Methotrexate
  • Methylprednisolone
  • Nelarabine
  • Pegaspargase
  • Positron Emission Tomography
  • Prednisolone
  • Prednisone
  • Questionnaire Administration
  • Radiation Therapy
  • Therapeutic Hydrocortisone
  • Thioguanine
  • Ultrasound Imaging
  • Vincristine Sulfate

Treatment groups

1,708 Participants
are divided into 4 treatment groups

Locations

This trial has no locations

Sponsors and collaborators