Targeted Immunotherapy After Myeloablative TBI-Based Conditioning & AlloHCT in CAYA With High Risk T-Cell ALL & Lymphoma

Conditions

• T-Cell Acute Lymphoblastic Lymphoma
• T-cell Acute Lymphoblastic Leukemia

Eligibility Criteria

Sex

ALL

Age

N/A - 39 Years

Healthy Volunteers

Not accepted

Interventions

• Daratumumab — DRUG
  Total body irradiation (TBI)-based myeloablative allogeneic hematopoietic stem cell transplantation (HCT) using best available donor. Daratumumab (DARA) treatment post-HCT Phase 1: 3 dose levels to determine safety (15 patients) Dose expansion: 1. Induction: DARA IV weekly x 8 doses (Weeks 1-8) 2. Consolidation: DARA every 2 weeks x 8 doses (Weeks 9-24) 3. Maintenance: DARA every 4 weeks (Stop at Day +270)

Study Details

A Phase I trial to determine the safety of targeted immunotherapy with daratumumab (DARA) IV after total body irradiation (TBI)-based myeloablative conditioning and allogeneic hematopoietic cell transplantation (HCT) for children, adolescents, and young adults (CAYA) with high risk T-cell acute lymphoblastic leukemia (T-ALL) or T-cell lymphoblastic lymphoma (T-LLy). Pre- and post-HCT NGS-MRD studies will be correlated with outcomes in children, adolescents, and young adults with T-ALL undergoing allogeneic HCT and post-HCT DARA treatment. The study will also evaluate T-cell repertoire and immune reconstitution prior to and following DARA post-HCT treatment and correlate with patient outcomes.

Key Dates

Start date

May 22, 2023

Status verified

Apr 2026

Primary completion

Sep 30, 2027

Completion

Sep 30, 2028

Study Design

Enrollment

30 participants (estimated)

Allocation

NA

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Other: Interventional
  Phase 1: 3 dose levels to determine safety (15 patients) Dose expansion: Daratumumab (DARA) treatment post-HCT 1. Induction: DARA IV weekly x 8 doses (Weeks 1-8) 2. Consolidation: DARA IV every 2 weeks x 8 doses (Weeks 9-24) 3. Maintenance: DARA IV every 4 weeks (Stop at Day +270)

Primary Outcome Measure

Patients with dose limiting toxicity (per CTCAE v.5) [ Time Frame: 60 days ]

Central Contacts

• Lauren Harrison, RN, MSN
  6172857844
  [email protected]
• Erin Morris, RN
  7149645359
  [email protected]

Locations (16)

Find similar trials in Phoeniz, AZ

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