Allogeneic Donor Lymphocyte Infusions Combined With Blinatumomab (DLI-TARGET)
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|ClinicalTrials.gov Identifier: NCT03982992|
Recruitment Status : Recruiting
First Posted : June 12, 2019
Last Update Posted : June 14, 2019
|Condition or disease||Intervention/treatment||Phase|
|B Cell Precursor Acute Lymphoblastic Leukemia With Mixed Chimerism or Minimal Residual Disease After Allogeneic Stem Cell Transplantation B-Cell Acute Lymphoblastic Leukemia Acute Lymphoblastic Leukemia Acute Lymphoblastic Leukemia in Remission Acute Lymphoblastic Leukemia, Adult||Drug: Blinatumomab in combination with donor lymphocyte infusion||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 2 Study Evaluating the Safety, Tolerability and Efficacy of Allogeneic Donor Lymphocyte Infusions Combined With Blinatumomab in Patients With Treatment-Resistant Mixed Chimerism or Minimal Residual Disease of B-precursor Acute Lymphoblastic Leukemia After Allogeneic Stem Cell Transplantation|
|Actual Study Start Date :||June 1, 2019|
|Estimated Primary Completion Date :||May 31, 2021|
|Estimated Study Completion Date :||November 30, 2021|
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
Continuous blinatumomab infusion in combination with allogeneic donor lymphocyte infusion
- 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 [ Time Frame: 18 weeks ]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.
- Efficacy of a combined treatment of DLI and blinatumomab to induce a complete MRD/chimerism response [ Time Frame: 18 weeks ]
MRD response based on RT-PCR: Complete MRD response (MolCR): hCR and MRD not detectable by molecular probe[s] with a sensitivity ≥10−4. The MRD response is calculated as: [number of patients achieving complete MRD response after at least one cycle (minimum 4 days blinatumomab) of study treatment] / [number of patients who received at least 1 cycle (minimum 4 days blinatumomab) of study treatment].
Mixed chimerism response: CC response: only donor STRs in bone marrow; Low-level MC response ≥90% but <100% donor STRs in bone marrow. The MC response is calculated as: [number of patients achieving CC/low-level MC response after at least one cycle (minimum 4 days blinatumomab) of study treatment] / [number of patients who received at least 1 cycle (minimum 4 days blinatumomab) of study treatment].
- Duration of the response and survival after combined treatment of DLI and blinatumomab [ Time Frame: 18 weeks ]For patients who received at least one cycle (minimum 4 days of blinatumomab), progression-free survival and overall survival will be calculated using kaplan-meier survival estimates. Descriptive summary statistics (N, mean, standard deviation, minimum, median and maximum) for the duration of response will be performed for all patients with an observed complete MRD response or CC/low-level MC response.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03982992
|Contact: DLI-TARGET Investigator Team||+49 (0)89 firstname.lastname@example.org|
|Contact: Christian Schmidt, MD||+49 (0)89 4400-77907||Christian_Schmidt@med.uni-muenchen.de|
|Klinikum der Universität München||Recruiting|
|Munich, Germany, 81377|
|Contact: Marion Subklewe, MD +49 (0)89 4400-73133 email@example.com|
|Contact: Christian Schmidt, MD +49 (0)89 4400-77907 Christian_Schmidt@med.uni-muenchen.de|
|Principal Investigator: Marion Subklewe, MD|
|Sub-Investigator: Christian Schmidt, MD|
|Sub-Investigator: Sascha Haubner, MD|
|Principal Investigator:||Marion Subklewe, MD||Klinikum der Universität München|
|Principal Investigator:||Christian Schmidt, MD||Klinikum der Universität München|
|Principal Investigator:||Sascha Haubner, MD||Klinikum der Universität München|