Ignite Creation Date:
2024-05-06 @ 2:30 PM
Last Modification Date:
2024-10-26 @ 1:32 PM
Study NCT ID:
NCT04334993
Status:
RECRUITING
Last Update Posted:
2021-05-07
First Post:
2020-03-31
Brief Title:
Pediatric-type Therapy With Pre-transplant Blinatumomab for HR Patients - Phase II Study
Sponsor:
Israeli Medical Association
Organization:
Israeli Medical Association
Study Overview
Official Title:
A Phase 2 Multicenter Single Arm Trial to Assess the Safety and Efficacy of a Pediatric Approach to for Young Adults With Acute Lymphoblastic Leukemia With Blinatumomab Therapy for High-risk Patients Prior to Allogeneic Transplantation
Status:
RECRUITING
Status Verified Date:
2020-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Despite recent therapeutic advancements the outcome of young adults with Philadelphia-negative Ph-neg acute lymphoblastic leukemia ALL and lymphoblastic lymphoma LBL remains unsatisfactory especially in those patients with high-risk disease features In young adults pediatric-based chemotherapy approaches improve outcome Furthermore there is evidence that pre-transplant antibody-based therapy may render patients with positive minimal residual disease MRD to an MRD-negative status MRD- and that this may be associated with improved post-transplant outcome
This is prospective study to evaluate the potential benefit of a modified pediatric-based approach in young adults with Ph-neg ALL Safety and efficacy of pre-transplant antibody-based consolidation in high-risk patients with Ph-neg ALL will be performed
This is prospective study to evaluate the potential benefit of a modified pediatric-based approach in young adults with Ph-neg ALL Safety and efficacy of pre-transplant antibody-based consolidation in high-risk patients with Ph-neg ALL will be performed
Detailed Description:
This is a national multicenter phase II clinical trial to evaluate the potential benefit of a modified pediatric-based approach in young adults with Ph-neg ALL Safety and efficacy of pre-transplant antibody-based consolidation in high-risk patients with Ph-neg ALL will be assessed
Young-adult patients eligible with Ph-neg ALL LBL and mixed phenotype acute leukemia MPAL will undergo risk stratification and started on the pediatric Italian Association of Pediatric Hematology Oncology-Berlin-Frankfurt-Münster AIEOP-BFM 2009 protocol Patients defined as having non-high-risk disease features non-HR as defined by MRD andor cytogenetic criteria will complete the non-HR chemotherapy arm per protocol Patients designated as having HR disease features after 2 induction blocks will be treated with CNS directed block followed by up to 2 cycles of blinatumomab for B-cell ALL followed by allogeneic stem cell transplantation All patients will be centrally assessed for MRD and for Ph-like status
Young-adult patients eligible with Ph-neg ALL LBL and mixed phenotype acute leukemia MPAL will undergo risk stratification and started on the pediatric Italian Association of Pediatric Hematology Oncology-Berlin-Frankfurt-Münster AIEOP-BFM 2009 protocol Patients defined as having non-high-risk disease features non-HR as defined by MRD andor cytogenetic criteria will complete the non-HR chemotherapy arm per protocol Patients designated as having HR disease features after 2 induction blocks will be treated with CNS directed block followed by up to 2 cycles of blinatumomab for B-cell ALL followed by allogeneic stem cell transplantation All patients will be centrally assessed for MRD and for Ph-like status
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None