Clinical Trials Logo
  1. Home
  2. Other
  3. NCT04972942

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

T-cell Acute Lymphoblastic Leukemia Clinical Trial

Official title:
Phase I Trial of Targeted Immunotherapy With Daratumumab Following Myeloablative TBI-Based Conditioning and AlloHCT in Children, Adolescents and Young Adults With High Risk T-Cell Acute Lymphoblastic Leukemia and Lymphoma (ALLO-T-DART)

Clinical Trial Summary

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.

Clinical Trial Description

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 cohort (DEC): Further evaluation of PK and PD (correlative studies/exploratory endpoints) to guide future selection of RP2D (15 patients) Treatment Schedule: 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) ;

Study Design

Related Conditions & MeSH terms

  • Leukemia
  • Leukemia, Lymphoid
  • Lymphoma
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
  • T-cell Acute Lymphoblastic Leukemia
  • T-Cell Acute Lymphoblastic Lymphoma
Clinical Trial Details
NCT number NCT04972942
Study type Interventional
Source New York Medical College
Contact Lauren Harrison, RN, MSN
Phone 6172857844
Email lauren_harrison@nymc.edu
Status Recruiting
Phase Phase 1
Start date May 22, 2023
Completion date September 2028
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT05032599 - Donor-Derived CD5 CAR T Cells in Subjects With Relapsed or Refractory T-Cell Acute Lymphoblastic Leukemia Phase 1
Recruiting NCT04033302 - Multi-CAR T Cell Therapy Targeting CD7-positive Malignancies Phase 1/Phase 2
Recruiting NCT05995028 - Universal 4SCAR7U Targeting CD7-positive Malignancies Phase 1
Recruiting NCT05596266 - CD5 CAR-T Therapy for Refractory/Relapsed CD5+ T-cell Acute Lymphoblastic Leukemia Phase 1
Completed NCT01950286 - Hyper-CVAD Treatment of Adult T-cell Acute Lymphoblastic Leukemia in Sweden. N/A
Completed NCT02518113 - A Study of LY3039478 in Combination With Dexamethasone in Participants With T-ALL/T-LBL Phase 1/Phase 2
Recruiting NCT03081910 - Autologous T-Cells Expressing a Second Generation CAR for Treatment of T-Cell Malignancies Expressing CD5 Antigen Phase 1
Recruiting NCT05290155 - Anti-CD7 CAR-T Cell Therapy for Relapse and Refractory CD7 Positive T Cell Malignancies Phase 1
Recruiting NCT05289687 - Daratumumab for Chemotherapy-Refractory Minimal Residual Disease in T Cell ALL Phase 2
Recruiting NCT06316427 - Autologous and Donor-derived CD7 CAR-T Therapy in Refractory or Relapsed T-cell Acute Lymphoblastic Leukemia/Lymphoma Phase 1/Phase 2
Recruiting NCT05277753 - NGS-MRD Assessment of Combination Immunotherapies Targeting T-ALL Phase 1
Recruiting NCT05679895 - Safety and Efficacy of OC-1 Therapy in Patients With R/R T-ALL/LL Phase 1
Active, not recruiting NCT04984356 - A Phase 1/2 Study of the Safety and Efficacy of Anti-CD7 Allogeneic CAR-T Cells (WU-CART-007) in Patients With Relapsed or Refractory T-ALL/LBL Phase 1/Phase 2
Recruiting NCT05832125 - Registry of Relapsed/Refractory T-cell Acute Lymphoblastic Leukemia
Withdrawn NCT04860817 - A Study of Anti-CD7 CAR-T Cells in Pediatric and Young Adult Patients With Relapse and Refractory T-ALL/ T-LBL Early Phase 1
Recruiting NCT04594135 - Anti-CD5 CAR T Cells for Relapsed/Refractory T Cell Malignancies Phase 1
Recruiting NCT04934774 - Non-gene Edited Anti-CD7 CAR T Cells for Relapsed/Refractory T Cell Malignances Phase 1
Enrolling by invitation NCT05509855 - A Long-Term Safety Follow-Up Study for Patients Treat With WU-CART-007
Recruiting NCT05376111 - Study of Venetoclax Combined With Azacitidine Regimen in Newly Diagnosed T-ALL Patients Phase 2