Acute Lymphoblastic Leukemia, in Relapse Clinical Trial
Official title:
Efficacy and Toxicity of Blinatumomab in the French Compassionate Use Program (ATU) for Adult Patients With B-cell Precursor Acute Lymphoblastic Leukemia (BCP-ALL) Refractory, in Relapse, or With Positive Minimal Residual Disease.
The outcome of young adults (18-60 years) with ALL has been dramatically improved by the use
of pediatric-inspired trials. About 60% of these young adult patients will be cured at 5
years. In this context, early evaluation of minimal residual disease (MRD) at complete
remission has been shown to be one of the most powerful prognostic factor, but also
predictive of the benefit of allogeneic stem cell transplantation (ASCT). Despite this global
improvement, about 30% of patients experience a relapse and will be exposed to be refractory
to salvage therapy or to early disease escape. In adult ALL, the most important prognostic
factors at relapse are : the time from first CR to relapse, the achievement of a second
complete remission (CR), and the feasibility of ASCT.
Blinatumomab is a bispecific T-cell engager that recruits T-cell on CD19 positive blast cells
and induces anti-leukemic cytotoxicity. In a phase 3 trial in relapse/refractory
Philadelphia-negative (Ph-) ALL, 43% of patients achieved a CR or CR with partial
hematological recovery (CRh), with the majority of responses occurring within the first
cycle. In patients with positive MRD (MRD+) BCP-ALL, blinatumomab resulted in complete MRD
response in 78% of patients after one cycle.
Between 2012 and 2016, blinatumomab was available in France for R/R and MRD+ ALL adult
patients through the French Compassionate Use Program. About 92 adult ALL were treated at
different stages of the disease in 27 centers.
To evaluate the efficacy of blinatumomab given in the French Compassionate Use Program, in
term of overall survival in both R/R (first cohort) and MRD positive (second cohort)
patients.
To evaluate the efficacy of blinatumomab given in the French Compassionate Use Program, in
term of CR/CRH in R/R patients, To evaluate the efficacy in term of molecular response in
both R/R and MRD+ cohorts, To evaluate the efficacy of blinatumomab given in the French
Compassionate Use Program, in both Ph+/Ph- ALL patients To evaluate the feasibility and the
safety of blinatumomab administration in a multi-center setting.To evaluate the feasibility
of allogeneic stem cell transplant after blinatumomab administration in both populations.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05066958 -
Ex-vivo Primed Memory Donor Lymphocyte Infusion to Boost Anti-viral Immunity After T-cell Depleted HSCT
|
Phase 1/Phase 2 | |
Completed |
NCT04224571 -
CCCG Relapsed Acute Lymphoblastic Leukemia 2017 Study in Children
|
Phase 2 | |
Recruiting |
NCT04888442 -
Phase I Study of pCAR-19B in the Treatment of Adult CD19-positive Relapsed/Refractory B-ALL
|
Phase 1 | |
Recruiting |
NCT05809284 -
Determining the Mechanisms of Loss of CAR T Cell Persistence
|
||
Recruiting |
NCT04049383 -
CAR-20/19-T Cells in Patients With Relapsed/Refractory B Cell ALL
|
Phase 1 | |
Not yet recruiting |
NCT05745714 -
HEM-iSMART-C: Ruxolitinib + Venetoclax + Dexamethasone + Cyclophosphamide and Cytarabine in Pediatric Patients With Relapsed or Refractory Hematological Malignancies
|
Phase 1/Phase 2 | |
Withdrawn |
NCT05740449 -
HEM-iSMART-A: Decitabine / Venetoclax and Navitoclax in Pediatric Patients With Relapsed or Refractory Hematological Malignancies
|
Phase 1/Phase 2 | |
Not yet recruiting |
NCT06213636 -
Fourth-gen CAR T Cells Targeting CD19/CD22 for Highly Resistant B-cell Lymphoma/Leukemia (PMBCL/CNS-BCL).
|
Phase 1/Phase 2 | |
Recruiting |
NCT04603872 -
CAR-T Cells Combined With Dasatinib for Patients With Relapsed and/or Refractory B-cell Hematological Malignancies
|
Early Phase 1 | |
Recruiting |
NCT04475731 -
Ponatinib in Adult Ph+ ALL Patients With MRD Positivity or Hematological Relapse
|
Phase 2 | |
Recruiting |
NCT06445803 -
CD19/CD22 CAR-T Cells in Adults With R/R ALL or NHL
|
Phase 1 | |
Recruiting |
NCT03957915 -
Study of Escalating Doses of INA03 Administered Intravenously as Single Agent in Adult Patients With Relapse/Refractory Acute Leukemia
|
Early Phase 1 | |
Terminated |
NCT03705507 -
International Trial of Selumetinib in Combination With Dexamethasone for the Treatment of Acute Lymphoblastic Leukaemia
|
Phase 1/Phase 2 | |
Recruiting |
NCT04325841 -
Phase II Study of Anti-CD19 CAR-T Cells Treating Leukemia Children
|
Phase 2 | |
Recruiting |
NCT04340167 -
Study of Anti-CD22 CAR-T Cells Treating Leukemia Children
|
Phase 2 | |
Recruiting |
NCT04605666 -
CD19-CAR-T2 Cells for CD19 Positive Acute Lymphoblastic Leukemia
|
Phase 2 | |
Active, not recruiting |
NCT04340154 -
Study of Sequential CAR-T Cell Treating Leukemia Children
|
Phase 2 | |
Recruiting |
NCT05292664 -
Venetoclax Basket Trial for High Risk Hematologic Malignancies
|
Phase 1 | |
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 |
NCT05310591 -
Combination of an Anti-PD1 Antibody With Tisagenlecleucel Reinfusion in Children, Adolescents and Young Adults With Acute Lymphoblastic Leukemia After Loss of Persistence
|
Phase 1/Phase 2 |