Trials Sponsors Conditions Drugs Pricing

Conditions

Acute Lymphoblastic Leukemia Acute Lymphoblastic Leukemia, Adult Acute Lymphoblastic Leukemia in Remission B Cell Precursor Acute Lymphoblastic Leukemia With Mixed Chimerism or Minimal Residual Disease After Allogeneic Stem Cell Transplantation B-Cell Acute Lymphoblastic Leukemia

Keywords

donor lymphocyte infusionblinatumomabcombinatorialminimal residual diseaseMRDmixed chimerismMCDLI-TARGETacute lymphoblastic leukemia

Outcome Measures

Primary Outcomes (1)

Safety and tolerability of combined DLI and blinatumomab treatment in subjects with treatment-resistant MC or MRD of CD19+ B-precursor ALL after allogeneic SCT
Subject incidence and grade of adverse events (AEs) including graft-versus-host disease (GvHD). The intensity of (S)AEs will be assessed according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.
18 weeks

Secondary Outcomes (2)

Efficacy of a combined treatment of DLI and blinatumomab to induce a complete MRD/chimerism response
18 weeks
Duration of the response and survival after combined treatment of DLI and blinatumomab
18 weeks

Study Arms (1)

DLI-TARGET

EXPERIMENTAL

14d screening period: methotrexate, cytarabine, dexamethasone infusion i.th. Cycle 1 (all patients): d1-28: blinatumomab continuous infusion i.v., d4: allogeneic donor lymphocyte single infusion i.v., d29: methotrexate, cytarabine, dexamethasone infusion i.th. Cycle 2 (only patients with toxicity ≤ grade 2 CTCAE in cycle 1): d43-d70: blinatumomab continuous infusion i.v., d46: allogeneic donor lymphocyte single infusion i.v., d71: methotrexate, cytarabine, dexamethasone infusion i.th.

Drug: Blinatumomab in combination with donor lymphocyte infusion

Interventions

Blinatumomab in combination with donor lymphocyte infusionDrug

Continuous blinatumomab infusion in combination with allogeneic donor lymphocyte infusion

DLI-TARGET

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Treatment programme
Blinatumomab in combination with donor lymphocyte infusion
The registry describes a treatment programme. Individual components, doses and actual administration are not established by this entry.
View registry record

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Adult patients with CD19+ B-precursor ALL (as determined by immunophenotyping) in hCR (defined as having less than 5% blasts in bone marrow) after allogeneic SCT.
One, or a combination of the following documented after an interval of at least 2 weeks since cessation of the most recent leukemia-targeting therapy (i.e. chemotherapy, immunotherapy or cellular therapy, except for intrathecal prophylaxis):

Sponsors & Collaborators

Ludwig-Maximilians - University of Munich
Otherlead
Amgen
Industrycollaborator

Study Sites (1)

Klinikum der Universität München

Munich, 81377, Germany

MeSH Terms

Conditions

Burkitt LymphomaPrecursor Cell Lymphoblastic Leukemia-LymphomaNeoplasm, Residual

Interventions

blinatumomab

Condition Hierarchy (Ancestors)

Epstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLymphoma, B-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic Type

Study Officials

Marion Subklewe, MD
LMU Klinikum
PRINCIPAL INVESTIGATOR
Christian Schmidt, MD
LMU Klinikum
PRINCIPAL INVESTIGATOR
Sascha Haubner, MD
LMU Klinikum
PRINCIPAL INVESTIGATOR

Enrollment

0 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Deputy Principal Investigator

Study Record Dates

First Submitted

June 3, 2019

First Posted

June 12, 2019

Study Start

June 1, 2019

Actual (reported)

Study Stopped

Allogeneic Donor Lymphocyte Infusions Combined With Blinatumomab

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (1)

DLI-TARGET

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (1)

DLI-TARGET

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations