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Blinatumomab in Adult Patients With Minimal Residual Disease (MRD) of B-precursor Acute Lymphoblastic Leukemia

Primary Purpose

ALL, Recurrent, Adult

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Blinatumomab
Sponsored by
Goethe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ALL, Recurrent, Adult focused on measuring ALL, acute lymphoblastic leukemia, MRD positive, minimal residual disease, blinatumomab

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients with CD19 positive B-precursor ALL in complete hematological remission defined as less than 5% blasts in bone marrow after at least three intense chemotherapy blocks (e.g., GMALL induction I-II/consolidation I).
  2. Presence of minimal residual disease (MRD) after an interval of at least 8 days from last systemic chemo-therapy

    • at a level of ≥10-4 - <10-3 (molecular failure or molecular relapse) in an assay with a minimum sensitivity of 10-4 documented after an interval of at least 2 weeks from last systemic chemotherapy OR
    • at levels below 10-4 documented after an interval of at least 2 weeks from last systemic chemotherapy:

      • Positive <10-4, non quantifiable (MolNE1) OR
      • Positive <10-4 (MolNE2) OR
    • Presence of minimal residual disease (MRD), non quantifiable (MolNE3).
  3. For evaluation of MRD patients must have at least one molecular marker based on individual rearrangements of immunoglobulin, TCR-genes or other suitable genes evaluated by the reference laboratory of the trial
  4. Bone marrow function as defined below:

    • ANC (Neutrophils) >= 1,000/µL
    • Platelets >= 50,000/µL (transfusion permitted)
    • HB level >= 9g/dl (transfusion permitted)
  5. Renal and hepatic function as defined below:

    • AST (GOT), ALT (GPT), and AP < 5 x upper limit of normal (ULN)
    • Total bilirubin < 1.5 x ULN (unless related to Gilbert's Meulengracht disease)
    • Creatinine < 1.5x ULN
    • Creatinine clearance >= 60 mL/min (e.g. calculated according Cockroft&Gault)
  6. Negative HIV test, negative hepatitis B (HbsAg) and hepatitis C virus (anti-HCV) test
  7. Negative pregnancy test in women of childbearing potential
  8. ECOG Performance Status 0 or 1
  9. Age >=18 years
  10. Ability to understand and willingness to sign a written informed consent
  11. Signed and dated written informed consent is available
  12. Participation in the registry of the German Multicenter Study Group for Adult ALL (GMALL)

Exclusion Criteria:

  1. Ph/BCR-ABL positive ALL
  2. Presence of circulating blasts or current extramedullary involvement by ALL
  3. History or presence of clinically relevant CNS pathology (e.g. seizure, paresis, aphasia, cerebrovascular ischemia/hemorrhage, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome or psychosis)
  4. Current detection of ALL blast cells in cerebro-spinal fluid
  5. History of or active relevant autoimmune disease
  6. Systemic cancer chemotherapy within 2 weeks prior to study treatment (except for intrathecal prophylaxis)
  7. Radiotherapy within 4 weeks prior to study treatment
  8. Live vaccination within 2 weeks before the start of study treatment
  9. Autologous hematopoietic stem cell transplantation (SCT) within six weeks prior to study treatment
  10. Allogeneic SCT within 12 weeks before the start of study treatment
  11. Any active acute Graft-versus-Host Disease (GvHD), grade 2-4 according to the Glucksberg criteria or active chronic GvHD requiring systemic treatment
  12. Any systemic therapy against GvHD within 2 weeks before start of study treatment
  13. Therapy with monoclonal antibodies (rituximab, alemtuzumab) within 4 weeks prior to study treatment
  14. Treatment with any investigational product within four weeks prior to study treatment
  15. Previous treatment with blinatumomab or other anti-CD19-therapy
  16. Known hypersensitivity to immunoglobulins or to any other component of the study drug formulation
  17. History of malignancy other than ALL diagnosed within 5 years prior to start of protocol-specified therapy with the exception of:

    • Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
    • Adequately treated cervical carcinoma in situ without evidence of disease
    • Adequately treated breast ductal carcinoma in situ without evidence of disease
    • Prostatic intraepithelial neoplasia without evidence of prostate cancer
  18. Active infection, any other concurrent disease or medical condition that are deemed to interfere with the conduct of the study as judged by the investigator
  19. Nursing women
  20. Woman of childbearing potential and is not willing to use 2 highly effective methods of contraception while receiving study treatment and for an additional 3 months after the last dose of study treatment.
  21. Male who has a female partner of childbearing potential, and is not willing to use 2 highly effective forms of contraception while receiving study treatment and for at least an additional 3 months after the last dose of study treatment

Sites / Locations

  • University Hospital of Frankfurt (Main)
  • Charité - Campus Benjamin Franklin
  • Uniklinik Dresden
  • Uniklinik Düsseldorf
  • Univeristätsklinikum Essen
  • Universitätsklinikum Freiburg
  • Universitätsmedizin Göttingen
  • Uniklinik Hamburg Eppendorf
  • Medizinische Hochschule Hannover
  • Uniklinik Heidelberg
  • UKSH-Kiel
  • Universitätsklinik Leipzig
  • Klinikum Mannheim
  • Universitätsklinkum Gießen und Marburg
  • Klinikum Großhadern
  • Uniklinik Münster
  • Klinikum Nürnberg Nord
  • Uniklinik Regensburg
  • Robert - Bosch - Krankenhaus
  • Universitätsklinik Tübingen
  • Universitätsklinkum Ulm
  • Uniklinik Würzburg

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Blinatumomab

Arm Description

Patients will receive four cycles of treatment, unless criteria for treatment discontinuation apply. The duration of one cycle is 6 weeks, including a four week continuous intravenous infusion and a two week infusion free interval, which may be extended by a maximum of 7 days. Patients entered with MRD level <10-4 (non quantifiable/MolNE1, quantifiable/MolNE2) or positive MRD, non quantifiable (MolNE3) will receive up to two cycles of Blinatumomab. Transfer of patients to alloHSCT after one cycle or after subsequent cycles is considered as per protocol discontinuation and as premature treatment discontinuation In case of hematological or extramedullary relapse, the study treatment will be permanently discontinued.

Outcomes

Primary Outcome Measures

MRD response after one cycle
Proportion of patients who achieve complete MRD response after one cycle of treatment with blinatumomab in patients with and without prior SCT

Secondary Outcome Measures

Continuous complete remission
Probability of continuous complete remission (remission duration) at 18 months following initiation of blinatumomab (Separate analysis of all outcome parameters in patients with MRD above 10-4, 10-4-10-3 and patients with MRD below 10-4 or non-quantifiable MRD)
Hematological relapse-free survival
Probability of hematological relapse-free survival rate at 18 months following initiation of blinatumomab (Separate analysis of all outcome parameters in patients with MRD above 10-4, 10-4-10-3 and patients with MRD below 10-4 or non-quantifiable MRD)
Overall survival
Probability of overall survival at 18 months following initiation of blinatumomab (Separate analysis of all outcome parameters in patients with MRD above 10-4, 10-4-10-3 and patients with MRD below 10-4 or non-quantifiable MRD)
Relapse localisations
Frequency of different relapse localisations in proportion to total hematological relapses (Separate analysis of all outcome parameters in patients with MRD above 10-4, 10-4-10-3 and patients with MRD below 10-4 or non-quantifiable MRD)
Biological evaluation of hematological and extramedullary relapse
Biological evaluation of hematological and extramedullary relapses including CD19 expression (Separate analysis of all outcome parameters in patients with MRD above 10-4, 10-4-10-3 and patients with MRD below 10-4 or non-quantifiable MRD)
Serious Adverse Event (SAE) incidence
Overall incidence and severity of adverse events in patients with and without prior SCT (CTCAE 4.0) (Separate analysis of all outcome parameters in patients with MRD above 10-4, 10-4-10-3 and patients with MRD below 10-4 or non-quantifiable MRD)
MRD response after two cycles
Proportion of patients who achieve MRD response after one or two cycles of treatment with Blinatumomab (Separate analysis of all outcome parameters in patients with MRD above 10-4, 10-4-10-3 and patients with MRD below 10-4 or non-quantifiable MRD)
complete MRD response after two cycles
Proportion of patients who achieve complete MRD response after two cycles of treatment with blinatumomab in patients with and without prior SCT (Separate analysis of all outcome parameters in patients with MRD above 10-4, 10-4-10-3 and patients with MRD below 10-4 or non-quantifiable MRD)
duration of MRD response
Probability of continuous MRD response and complete MRD response and duration of MRD response at 18 months following initiation of blinatumomab (Separate analysis of all outcome parameters in patients with MRD above 10-4, 10-4-10-3 and patients with MRD below 10-4 or non-quantifiable MRD)
Time to MRD response
Time to MRD response measured by time-point of first achievement (Separate analysis of all outcome parameters in patients with MRD above 10-4, 10-4-10-3 and patients with MRD below 10-4 or non-quantifiable MRD)
GvHD
Evaluation of GvHD as part of AE documentation and according to Glucksberg Criteria, grade and localisation. (Separate analysis of all outcome parameters in patients with MRD above 10-4, 10-4-10-3 and patients with MRD below 10-4 or non-quantifiable MRD)
treatment related mortality after subsequent SCT
Evaluation of overall survival, remission duration, relapse-free survival and treatment related mortality (at day 100 and later) in patients with SCT in complete remission after blinatumomab (Separate analysis of all outcome parameters in patients with MRD above 10-4, 10-4-10-3 and patients with MRD below 10-4 or non-quantifiable MRD)
treatment related mortality
Evaluation of overall survival, remission duration, relapse-free survival and treatment related mortality in patients without SCT in complete remission after blinatumomab (Separate analysis of all outcome parameters in patients with MRD above 10-4, 10-4-10-3 and patients with MRD below 10-4 or non-quantifiable MRD)
Quality of Life
Measurement of Quality of Life with EORTC instruments (EORTC QLQ C30 and EQ-5D) at different time-points during treatment (Separate analysis of all outcome parameters in patients with MRD above 10-4, 10-4-10-3 and patients with MRD below 10-4 or non-quantifiable MRD)

Full Information

First Posted
March 13, 2017
Last Updated
March 17, 2023
Sponsor
Goethe University
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1. Study Identification

Unique Protocol Identification Number
NCT03109093
Brief Title
Blinatumomab in Adult Patients With Minimal Residual Disease (MRD) of B-precursor Acute Lymphoblastic Leukemia
Official Title
A Multicenter, Single-arm Study to Assess the Efficacy, Safety, and Tolerability of the BiTE® Antibody Blinatumomab in Adult Patients With Minimal Residual Disease (MRD) of B-precursor Acute Lymphoblastic Leukemia (Blast Successor Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
March 15, 2017 (Actual)
Primary Completion Date
August 15, 2021 (Actual)
Study Completion Date
March 10, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Goethe University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is designed to confirm the efficacy, safety, and tolerability of blinatumomab in patients with MRD of B- precursor ALL in complete hematological remission including patients with relapse after SCT. The study aims to expand experience generated in previous trials in patients with MRD positive ALL with a focus on additional specific questions.
Detailed Description
Transfer of patients to alloHSCT after one cycle or after a subsequent cycle is considered as per protocol discontinuation and as premature treatment discontinuation. In case of hematological or extramedullary relapse, the study treatment will be permanently discontinued. There will be a safety follow-up visit at 30 days after end of the last infusion. There will be efficacy follow-up until 18 months after treatment start. In patients scheduled for SCT the 30-day safety-visit may be performed at the latest time point possible before initiation of subsequent treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ALL, Recurrent, Adult
Keywords
ALL, acute lymphoblastic leukemia, MRD positive, minimal residual disease, blinatumomab

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
83 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Blinatumomab
Arm Type
Experimental
Arm Description
Patients will receive four cycles of treatment, unless criteria for treatment discontinuation apply. The duration of one cycle is 6 weeks, including a four week continuous intravenous infusion and a two week infusion free interval, which may be extended by a maximum of 7 days. Patients entered with MRD level <10-4 (non quantifiable/MolNE1, quantifiable/MolNE2) or positive MRD, non quantifiable (MolNE3) will receive up to two cycles of Blinatumomab. Transfer of patients to alloHSCT after one cycle or after subsequent cycles is considered as per protocol discontinuation and as premature treatment discontinuation In case of hematological or extramedullary relapse, the study treatment will be permanently discontinued.
Intervention Type
Drug
Intervention Name(s)
Blinatumomab
Other Intervention Name(s)
blincyto
Intervention Description
Patients will receive blinatumomab at a dose of 28 µg/day as continuous intravenous infusion at constant flow rate for four weeks, followed by a two-week infusion free interval, defined as one treatment cycle. Up to of four cycles will be performed. In case of defined toxicities, the dose of blinatumomab may be reduced to 9µg/day. Patients with an MRD relapse may qualify to receive additional treatment with blinatumomab.
Primary Outcome Measure Information:
Title
MRD response after one cycle
Description
Proportion of patients who achieve complete MRD response after one cycle of treatment with blinatumomab in patients with and without prior SCT
Time Frame
after one cycle of treatment (up to 43 days)
Secondary Outcome Measure Information:
Title
Continuous complete remission
Description
Probability of continuous complete remission (remission duration) at 18 months following initiation of blinatumomab (Separate analysis of all outcome parameters in patients with MRD above 10-4, 10-4-10-3 and patients with MRD below 10-4 or non-quantifiable MRD)
Time Frame
18 months following initiation of blinatumomab
Title
Hematological relapse-free survival
Description
Probability of hematological relapse-free survival rate at 18 months following initiation of blinatumomab (Separate analysis of all outcome parameters in patients with MRD above 10-4, 10-4-10-3 and patients with MRD below 10-4 or non-quantifiable MRD)
Time Frame
18 months following initiation of blinatumomab
Title
Overall survival
Description
Probability of overall survival at 18 months following initiation of blinatumomab (Separate analysis of all outcome parameters in patients with MRD above 10-4, 10-4-10-3 and patients with MRD below 10-4 or non-quantifiable MRD)
Time Frame
18 months following initiation of blinatumomab
Title
Relapse localisations
Description
Frequency of different relapse localisations in proportion to total hematological relapses (Separate analysis of all outcome parameters in patients with MRD above 10-4, 10-4-10-3 and patients with MRD below 10-4 or non-quantifiable MRD)
Time Frame
In Case of Relapse, continuously until End of Follow-Up (up to 18 Months)
Title
Biological evaluation of hematological and extramedullary relapse
Description
Biological evaluation of hematological and extramedullary relapses including CD19 expression (Separate analysis of all outcome parameters in patients with MRD above 10-4, 10-4-10-3 and patients with MRD below 10-4 or non-quantifiable MRD)
Time Frame
In Case of Relapse, continuously until End of Follow-Up (up to 18 Months)
Title
Serious Adverse Event (SAE) incidence
Description
Overall incidence and severity of adverse events in patients with and without prior SCT (CTCAE 4.0) (Separate analysis of all outcome parameters in patients with MRD above 10-4, 10-4-10-3 and patients with MRD below 10-4 or non-quantifiable MRD)
Time Frame
continuously until End of Safety-Follow-Up (up to 26 weeks)
Title
MRD response after two cycles
Description
Proportion of patients who achieve MRD response after one or two cycles of treatment with Blinatumomab (Separate analysis of all outcome parameters in patients with MRD above 10-4, 10-4-10-3 and patients with MRD below 10-4 or non-quantifiable MRD)
Time Frame
after two cycles of treatment (up to 85 days)
Title
complete MRD response after two cycles
Description
Proportion of patients who achieve complete MRD response after two cycles of treatment with blinatumomab in patients with and without prior SCT (Separate analysis of all outcome parameters in patients with MRD above 10-4, 10-4-10-3 and patients with MRD below 10-4 or non-quantifiable MRD)
Time Frame
after two cycles of treatment (up to 85 days)
Title
duration of MRD response
Description
Probability of continuous MRD response and complete MRD response and duration of MRD response at 18 months following initiation of blinatumomab (Separate analysis of all outcome parameters in patients with MRD above 10-4, 10-4-10-3 and patients with MRD below 10-4 or non-quantifiable MRD)
Time Frame
18 months following initiation of blinatumomab
Title
Time to MRD response
Description
Time to MRD response measured by time-point of first achievement (Separate analysis of all outcome parameters in patients with MRD above 10-4, 10-4-10-3 and patients with MRD below 10-4 or non-quantifiable MRD)
Time Frame
MRD determination after each cycle of treatment (up to 24 weeks)
Title
GvHD
Description
Evaluation of GvHD as part of AE documentation and according to Glucksberg Criteria, grade and localisation. (Separate analysis of all outcome parameters in patients with MRD above 10-4, 10-4-10-3 and patients with MRD below 10-4 or non-quantifiable MRD)
Time Frame
until End of Safety-Follow-Up (up to 26 weeks)
Title
treatment related mortality after subsequent SCT
Description
Evaluation of overall survival, remission duration, relapse-free survival and treatment related mortality (at day 100 and later) in patients with SCT in complete remission after blinatumomab (Separate analysis of all outcome parameters in patients with MRD above 10-4, 10-4-10-3 and patients with MRD below 10-4 or non-quantifiable MRD)
Time Frame
after subsequent SCT (at day 100 and later)
Title
treatment related mortality
Description
Evaluation of overall survival, remission duration, relapse-free survival and treatment related mortality in patients without SCT in complete remission after blinatumomab (Separate analysis of all outcome parameters in patients with MRD above 10-4, 10-4-10-3 and patients with MRD below 10-4 or non-quantifiable MRD)
Time Frame
continuously until End of Follow-Up (up to 18 Months)
Title
Quality of Life
Description
Measurement of Quality of Life with EORTC instruments (EORTC QLQ C30 and EQ-5D) at different time-points during treatment (Separate analysis of all outcome parameters in patients with MRD above 10-4, 10-4-10-3 and patients with MRD below 10-4 or non-quantifiable MRD)
Time Frame
until End of Follow-Up (up to 18 Months)
Other Pre-specified Outcome Measures:
Title
Treatment deviation1
Description
Incidence of dose reductions
Time Frame
until end of treatment (up to 22 weeks)
Title
Treatment deviation2
Description
incidence of treatment interruptions
Time Frame
until end of treatment (up to 22 weeks)
Title
Treatment deviation3
Description
days of interruption
Time Frame
until end of treatment (up to 22 weeks)
Title
Treatment deviation4
Description
withdrawals
Time Frame
until end of treatment (up to 22 weeks)
Title
Treatment deviation5
Description
total delivered dose
Time Frame
until end of treatment (up to 22 weeks)
Title
Treatment deviation6
Description
total days of treatment
Time Frame
until end of treatment (up to 22 weeks)
Title
Treatment deviation7
Description
realisation rate calculated as scheduled total dose/delivered total dose
Time Frame
until end of treatment (up to 22 weeks)
Title
Hospitalisation days
Description
Number of hospitalisation days
Time Frame
until end of treatment (up to 22 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with CD19 positive B-precursor ALL in complete hematological remission defined as less than 5% blasts in bone marrow after at least three intense chemotherapy blocks (e.g., GMALL induction I-II/consolidation I). Presence of minimal residual disease (MRD) after an interval of at least 8 days from last systemic chemo-therapy at a level of ≥10-4 - <10-3 (molecular failure or molecular relapse) in an assay with a minimum sensitivity of 10-4 documented after an interval of at least 2 weeks from last systemic chemotherapy OR at levels below 10-4 documented after an interval of at least 2 weeks from last systemic chemotherapy: Positive <10-4, non quantifiable (MolNE1) OR Positive <10-4 (MolNE2) OR Presence of minimal residual disease (MRD), non quantifiable (MolNE3). For evaluation of MRD patients must have at least one molecular marker based on individual rearrangements of immunoglobulin, TCR-genes or other suitable genes evaluated by the reference laboratory of the trial Bone marrow function as defined below: ANC (Neutrophils) >= 1,000/µL Platelets >= 50,000/µL (transfusion permitted) HB level >= 9g/dl (transfusion permitted) Renal and hepatic function as defined below: AST (GOT), ALT (GPT), and AP < 5 x upper limit of normal (ULN) Total bilirubin < 1.5 x ULN (unless related to Gilbert's Meulengracht disease) Creatinine < 1.5x ULN Creatinine clearance >= 60 mL/min (e.g. calculated according Cockroft&Gault) Negative HIV test, negative hepatitis B (HbsAg) and hepatitis C virus (anti-HCV) test Negative pregnancy test in women of childbearing potential ECOG Performance Status 0 or 1 Age >=18 years Ability to understand and willingness to sign a written informed consent Signed and dated written informed consent is available Participation in the registry of the German Multicenter Study Group for Adult ALL (GMALL) Exclusion Criteria: Ph/BCR-ABL positive ALL Presence of circulating blasts or current extramedullary involvement by ALL History or presence of clinically relevant CNS pathology (e.g. seizure, paresis, aphasia, cerebrovascular ischemia/hemorrhage, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome or psychosis) Current detection of ALL blast cells in cerebro-spinal fluid History of or active relevant autoimmune disease Systemic cancer chemotherapy within 2 weeks prior to study treatment (except for intrathecal prophylaxis) Radiotherapy within 4 weeks prior to study treatment Live vaccination within 2 weeks before the start of study treatment Autologous hematopoietic stem cell transplantation (SCT) within six weeks prior to study treatment Allogeneic SCT within 12 weeks before the start of study treatment Any active acute Graft-versus-Host Disease (GvHD), grade 2-4 according to the Glucksberg criteria or active chronic GvHD requiring systemic treatment Any systemic therapy against GvHD within 2 weeks before start of study treatment Therapy with monoclonal antibodies (rituximab, alemtuzumab) within 4 weeks prior to study treatment Treatment with any investigational product within four weeks prior to study treatment Previous treatment with blinatumomab or other anti-CD19-therapy Known hypersensitivity to immunoglobulins or to any other component of the study drug formulation History of malignancy other than ALL diagnosed within 5 years prior to start of protocol-specified therapy with the exception of: Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease Adequately treated cervical carcinoma in situ without evidence of disease Adequately treated breast ductal carcinoma in situ without evidence of disease Prostatic intraepithelial neoplasia without evidence of prostate cancer Active infection, any other concurrent disease or medical condition that are deemed to interfere with the conduct of the study as judged by the investigator Nursing women Woman of childbearing potential and is not willing to use 2 highly effective methods of contraception while receiving study treatment and for an additional 3 months after the last dose of study treatment. Male who has a female partner of childbearing potential, and is not willing to use 2 highly effective forms of contraception while receiving study treatment and for at least an additional 3 months after the last dose of study treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicola Goekbuget, MD
Organizational Affiliation
GMALL-Study-Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Frankfurt (Main)
City
Frankfurt (Main)
State/Province
Hessen
ZIP/Postal Code
60590
Country
Germany
Facility Name
Charité - Campus Benjamin Franklin
City
Berlin
Country
Germany
Facility Name
Uniklinik Dresden
City
Dresden
Country
Germany
Facility Name
Uniklinik Düsseldorf
City
Düsseldorf
Country
Germany
Facility Name
Univeristätsklinikum Essen
City
Essen
Country
Germany
Facility Name
Universitätsklinikum Freiburg
City
Freiburg
Country
Germany
Facility Name
Universitätsmedizin Göttingen
City
Göttingen
Country
Germany
Facility Name
Uniklinik Hamburg Eppendorf
City
Hamburg
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
Country
Germany
Facility Name
Uniklinik Heidelberg
City
Heidelberg
Country
Germany
Facility Name
UKSH-Kiel
City
Kiel
Country
Germany
Facility Name
Universitätsklinik Leipzig
City
Leipzig
Country
Germany
Facility Name
Klinikum Mannheim
City
Mannheim
Country
Germany
Facility Name
Universitätsklinkum Gießen und Marburg
City
Marburg
Country
Germany
Facility Name
Klinikum Großhadern
City
München
Country
Germany
Facility Name
Uniklinik Münster
City
Münster
Country
Germany
Facility Name
Klinikum Nürnberg Nord
City
Nürnberg
Country
Germany
Facility Name
Uniklinik Regensburg
City
Regensburg
Country
Germany
Facility Name
Robert - Bosch - Krankenhaus
City
Stuttgart
Country
Germany
Facility Name
Universitätsklinik Tübingen
City
Tübingen
Country
Germany
Facility Name
Universitätsklinkum Ulm
City
Ulm
Country
Germany
Facility Name
Uniklinik Würzburg
City
Würzburg
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
Citation
Gökbuget N, et al . Interim Results of a Multicenter, Single-Arm Study to Assess Blinatumomab in Adult Patients (pts) with Minimal Residual Disease (MRD) of B-Precursor (BCP) Acute Lymphoblastic Leukemia (GMALL-MOLACT1-BLINA). Blood (2020) 136 (Supplement 1): 39-40.
Results Reference
result

Learn more about this trial

Blinatumomab in Adult Patients With Minimal Residual Disease (MRD) of B-precursor Acute Lymphoblastic Leukemia

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