Philadelphia Chromosome-negative or BCR-ABL-negative, CD19-positive ALLPhase 2NCT03523429
PETHEMA-BLIN-01/PET069014 (BLIN-01)
A Phase 2 study testing blinatumomab in people with Philadelphia Chromosome-negative or BCR-ABL-negative, CD19-positive ALL, run by PETHEMA Foundation at 12 sites in Spain.
Trial summary
The PETHEMA Spanish group treats patients with high-risk Philadelphia chromosome-negative ALL, aged 18 to 55 years, based on the MRD clearance as assessed by flow cytometry at a centralised evaluation centre. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Philadelphia Chromosome-negative or BCR-ABL-negative, CD19-positive ALL
- What is being tested?
- blinatumomab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 12 sitesSpain
- Study dates
- 30 Jun 2018to 9 Mar 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Men and women between 18 to 55 years of age, both inclusive.
- Patients with Philadelphia chromosome-negative or BCR-ABL-negative, CD19-positive ALL, with high-risk characteristics. The definition of high-risk ALL implies the presence of one or more of the following factors: Aged 30-55 years; Leukocytes > 30×109/l in B-precursor ALL; Any of the following cytogenetic or molecular abnormalities: 11q23 abnormalities, or proven MLL rearrangement; Complex karyotype (more than 5 chromosome abnormalities); Pro-B ALL, regardless of the number of leukocytes.
- Previous treatment according to routine clinical practice in Spanish centres, in accordance with the PETHEMA protocol for patients with high-risk ALL (ALL-AR-11), in complete remission (MRD < 0.1%) (< 1×10-3) centralised assessment through flow cytometry) after induction therapy.
- ECOG < 2.
- Ability to understand the study and willingness to sign the written informed consent form
Who cannot join
- Philadelphia chromosome-positive (Ph+) ALL.
- Burkitt's leukaemia (mature B phenotype) according to the WHO classification.
- T-cell ALL.
- B-precursor ALL with high-risk characteristics and MRD ≥ 0.1% (≥ 1×10-3) after receiving induction chemotherapy.
- Previous history or presence of a clinically significant disease of the central nervous system (CNS): epilepsy, seizures, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, psychosis.
- Presence or history of an autoimmune disease potentially affecting the CNS.
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- Radiotherapy in the 2 weeks prior to starting treatment with blinatumomab.
- Immunotherapy (e.g., rituximab) within 4 weeks prior to starting treatment with blinatumomab.
- Any investigational product for leukaemia in the 4 weeks prior to starting treatment with blinatumomab.
- Treatment with any investigational medicinal product after signing the informed consent form.
- Candidate patient for allogeneic haematopoietic stem cell transplantation (HSCT) at the time of enrolment.
- Known hypersensitivity to human immunoglobulins or to any component of the investigational product.
- Abnormal laboratory values: AST (SGOT) and/or ALT (SGPT) and/or alkaline phosphatase ≥ 5 ULN;total bilirubin ≥ 1.5 ULN (unless related to Gilbert's syndrome or Meulengracht's disease); Creatinine ≥ 1.5 ULN; Estimated creatinine clearance < 50 ml/min; Haemoglobin ≥ 9 g/dl (transfusion permitted).
- History of malignant disease other than ALL in the 5 years prior to starting treatment with blinatumomab, with the exception of basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.
- Active uncontrolled infection, or any other concurrent disease or medical condition considered to interfere with the conduct of the study as per the investigator's discretion.
- HIV infection or chronic hepatitis B virus (HBsAg positive) or hepatitis C virus infection (anti-HCV positive).
- Pregnant or breast-feeding women.
- Women of childbearing potential who are not willing use an effective method of contraception during their participation in the study and for at least 3 months thereafter. Men who are not willing to take measures to prevent their partner from becoming pregnant during their participation in the study and for at least 3 months thereafter.
- Prior treatment with blinatumomab.
- Patients who do not want or are unable to meet the protocol requirements
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Spain12 sites
Hospital Germans Trias i Pujol
Badalona, Barcelona
Hospital Clínic de Barcelona
Barcelona
Hospital de la Santa Creu i Sant Pau
Barcelona
Hospital ICO Hospitalet
Barcelona
Hospital Vall d'Hebron
Barcelona
Hospital Universitario 12 de Octubre
Madrid
. Hospital Clínico Universitario Virgen de la Victoria
Málaga
Hospital Central de Asturias
Oviedo
Hospital Clinico Universitario de Salamanca
Salamanca
C.H.U, de Santiago
Santiago de Compostela
H. Virgen Del Rocio
Seville
Hospital Universitario y Politécnico la Fe
Valencia
About this study
Official title: A Phase II, Open-label Study to Evaluate the Effect of Blinatumomab Administered During Consolidation to Reduce the Level of Minimal Residual Disease (MRD) Assessed Through Flow Cytometry in Adult Patients up to 55 Years of Age With High-risk Philadelphia Chromosome-negative (Ph-) Acute Lymphoblastic Leukaemia (ALL) With Good Response (MRD < 0.1%) After Induction Therapy
The PETHEMA Spanish group treats patients with high-risk Philadelphia chromosome-negative ALL, aged 18 to 55 years, based on the MRD clearance as assessed by flow cytometry at a centralised evaluation centre. Patients with MRD < 0.1% (< 1×10-3) after induction and < 0.01% (< 1×10-4) after early consolidation are assigned to receive chemotherapy (late consolidation and maintenance).
Early consolidation chemotherapy consists of three cycles including high doses of MTX, ARA-C and ASP, together with vincristine and dexamethasone. The same therapy is repeated in the late consolidation period if MRD after early consolidation is < 0.01% (< 1×10-4). Maintenance therapy is then administered for up to 2 years from the CR date. These patients do not receive allo-HSCT if they maintain adequate MRD clearance.
Read more
Despite having adequate MRD clearance, a proportion of patients (around 25%) experience relapse, which makes other approaches necessary to try to decrease the relapse rate. Intensifying currently existing chemotherapy regimens is not likely to increase the cure rate and would likely significantly increase toxicity. The use of targeted immunotherapeutic agents such as blinatumomab, which has demonstrated efficacy and safety in patients with R/R ALL and in patients with ALL and MRD+, seems to be a promising option [30-33].
Therefore, it would be interesting to assess the potential efficacy of using blinatumomab in CR patients to reduce the MRD more frequently and more intensely during the early and late consolidation period. Our hypothesis is that blinatumomab will further reduce the level of MRD and this could lead to a decrease in the relapse rate in these patients.
This trial will replace the third early consolidation cycle with a cycle of blinatumomab, and the same will be done in the late consolidation period. We hope that this strategy will increase the extent of the MRD response and prevent relapses.
Moreover, and as a secondary objective, we will investigate the safety of blinatumomab administration after the administration of high-dose chemotherapy including MTX, ARA-C and ASP
Read the detailed description
In the pre-phase, patients receive treatment according to routine clinical practice at Spanish sites, in accordance with the PETHEMA protocol for patients with high-risk ALL (ALL-AR-11), with: Prednisone (PDN) 60 mg/m2, PO or IV until complete characterisation of the ALL, for a maximum of 7 days, Triple intrathecal therapy, Methotrexate (MTX) 12 mg, ARA-C: 30 mg, Hydrocortisone 20 mg.
Standard induction chemotherapy that these patients receive according to routine clinical practice at Spanish sites, in accordance with the PETHEMA protocol for patients with high-risk ALL (ALL-AR-11), consists of: Vincristine (VCR) 1.5 mg/m2 (maximum dose 2 mg) IV days 1, 8, 15 and 22,Daunorubicin (DNR) 45 mg/m2 IV days 1, 8, 15 and 22, prednisone 60 mg/m2 per day, IV or PO, days 1 to 14,30 mg/m2 per day, IV or PO, days 15 to 21, 15 mg/m2 per day, IV or PO, days 21 to 28,E. coli L-asparaginase (L-ASP) (Kidrolase®) 10,000 IU/m2, IV, days 16-20, 23-27,Intrathecal TIT chemotherapy day 1* (if not administered in the pre-phase) and 22, Methotrexate (MTX) 12 mg, ARA-C: 30 mg, Hydrocortisone 20 mg, G-CSF (SC or IV) from day 15 until neutrophils > 1000/µl.
Following the administration of induction therapy, a bone marrow analysis will be performed with morphological, genetic and molecular study if necessary, with a centralised MRD determination by MFC. In the case of a complete morphological response and MRD < 0.1% (< 1×10-3), the patient will be enrolled in the trial and receive consolidation and maintenance treatment according to protocol.
Consolidation - CYCLE 1 Early consolidation chemotherapy that the patients will receive in the first cycle (21 days) consists of: dexamethasone 20 mg/m2 per day, PO or IV days 1-5, 10 mg/m2 per day, PO or IV day 6, 5 mg/m2 per day, PO or IV day 7, 2.5 mg/m2 per day, PO or IV day 8, Vincristine 1.5 mg/m2 per day, IV (maximum 2 mg) days 1 and 8, Methotrexare 3g/m2, IV in 24 hours, E. coli L-asparaginase (L-ASP) (Kidrolase®): 20,000 IU/m2, IV, day 3,Triple intrathecal therapy day 1.
Consolidation - CYCLE 2
Early consolidation chemotherapy that the patient will receive in the second cycle (21 days) consists of:
- Dexamethasone:
- 20 mg/m2 per day, PO or IV days 1-5.
- 10 mg/m2 per day, PO or IV day 6.
- 5 mg/m2 per day, PO or IV day 7.
- 2.5 mg/m2 per day, PO or IV day 8.
- ARA-C:
- 2 g/m2 every 12 hours, over 3 hours, days 1 and 2. Halve the ARA-C for patients over 50 years of age.
- E. coli L-asparaginase (L-ASP) (Kidrolase®): 20,000 IU/m2, IV, day 3. Halve the dose for patients over 50 years of age as the toxicity of any type of ASP increases with age.
- Triple intrathecal therapy day 4 (administered that day to keep the intrathecal therapy separate from the high-dose ARA-C).
Consolidation - CYCLE 3 In the third early consolidation cycle, the investigational drug blinatumomab will be administered.
- Blinatumomab 28 μg/day as a continuous infusion, IV over 4 weeks.
- Triple intrathecal therapy day 1.
Late consolidation Two weeks after completing the blinatumomab treatment, in the case of MRD < 0.01% (< 1×10-4), patients will receive 2 blocks of intensive chemotherapy (identical to those in early consolidation), separated by 3 weeks, followed by a treatment cycle with blinatumomab, the investigational medicinal product, for 4 weeks.
After administering late consolidation therapy, a bone marrow study will be conducted. In the case of MRD < 0.01% (< 1×10-4), the patient will receive maintenance treatment. If this MRD level is not achieved, the patient will be withdrawn from the study and undergo a haematopoietic stem cell transplantation, according to routine clinical practice at Spanish sites.
The maintenance therapy that patients will receive in this phase of the trial will consist of continuous chemotherapy administration (mercaptopurine and methotrexate) with reinductions for up to one year from CR
- Being tested
- blinatumomab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blinatumomabDrug
Blinatumomab is a bispecific monoclonal antibody designed to bind specifically to CD19, expressed on the surface of B-cells, and to CD3, expressed on the surface of T-cells. It activates endogenous T-cells by connecting the CD3 on the T-cell receptor complex (TCR) with the CD19 on the B-cells. The anti-tumour activity of blinatumomab does not depend on whether the T-cells carry a specific TCR or peptide antigens present in cancer cells, but it is polyclonal and independent of HLA on the target cells
| Study group | Role | What they receive |
|---|---|---|
| blinatumomab | Experimental | blinatumomab administered during the early consolidation phase in patients ≤ 55 years with high-risk Philadelphia chromosome-negative (Ph-) acute lymphoblastic leukaemia (ALL) with MRD < 0.1% (< 1×10-3) after induction therapy. Receives: Drug: blinatumomab |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the reduction rate of the Minimal residual disease determined by Multiparametric flow cytometry
To assess the reduction rate of the MRD determined by MFC, after early consolidation following the inclusion of blinatumomab administered during the early consolidation phase in patients ≤ 55 years of age with high-risk Philadelphia chromosome-negative (Ph-) acute lymphoblastic leukaemia (ALL) with MRD < 0.1% (< 1×10-3) after induction therapy.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2018
- Study start30 Jun 2018
- Primary completion24 Dec 2019
- Study completion9 Mar 2022
Why it stopped: Low rate of recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Philadelphia Chromosome-negative or BCR-ABL-negative, CD19-positive ALLStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- PETHEMA Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03523429
- Sponsor's protocol ID
- PETHEMA-BLIN-01
- Status last verified
- Jul 2022
- First submitted
- 1 May 2018
- Last updated
- 27 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Open-label Study to Evaluate the Effect of Blinatumomab Administered During Consolidation to Reduce the Level of Minimal Residual Disease (MRD) Assessed Through Flow Cytometry in Adult Patients up to 55 Years of Age With High-risk Philadelphia Chromosome-negative (Ph-) Acute Lymphoblastic Leukaemia (ALL) With Good Response (MRD < 0.1%) After Induction Therapy
- ClinicalTrials.gov ID
- NCT03523429
- Acronym / sponsor ID
- PETHEMA-BLIN-01
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low rate of recruitment
- Enrolment
- 11 participants (actual)
- Lead sponsor
- PETHEMA FoundationUniversity, hospital or other
- Study start
- 30 Jun 2018 (actual)
- Primary completion
- 24 Dec 2019 (actual)
- Study completion
- 9 Mar 2022 (actual)
- First posted
- 14 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The PETHEMA Spanish group treats patients with high-risk Philadelphia chromosome-negative ALL, aged 18 to 55 years, based on the MRD clearance as assessed by flow cytometry at a centralised evaluation centre. Patients with MRD < 0.1% (< 1×10-3) after induction and < 0.01% (< 1×10-4) after early consolidation are assigned to receive chemotherapy (late consolidation and maintenance).
Early consolidation chemotherapy consists of three cycles including high doses of MTX, ARA-C and ASP, together with vincristine and dexamethasone. The same therapy is repeated in the late consolidation period if MRD after early consolidation is < 0.01% (< 1×10-4). Maintenance therapy is then administered for up to 2 years from the CR date. These patients do not receive allo-HSCT if they maintain adequate MRD clearance.
Despite having adequate MRD clearance, a proportion of patients (around 25%) experience relapse, which makes other approaches necessary to try to decrease the relapse rate. Intensifying currently existing chemotherapy regimens is not likely to increase the cure rate and would likely significantly increase toxicity. The use of targeted immunotherapeutic agents such as blinatumomab, which has demonstrated efficacy and safety in patients with R/R ALL and in patients with ALL and MRD+, seems to be a promising option [30-33].
Therefore, it would be interesting to assess the potential efficacy of using blinatumomab in CR patients to reduce the MRD more frequently and more intensely during the early and late consolidation period. Our hypothesis is that blinatumomab will further reduce the level of MRD and this could lead to a decrease in the relapse rate in these patients.
This trial will replace the third early consolidation cycle with a cycle of blinatumomab, and the same will be done in the late consolidation period. We hope that this strategy will increase the extent of the MRD response and prevent relapses.
Moreover, and as a secondary objective, we will investigate the safety of blinatumomab administration after the administration of high-dose chemotherapy including MTX, ARA-C and ASP
Detailed description
In the pre-phase, patients receive treatment according to routine clinical practice at Spanish sites, in accordance with the PETHEMA protocol for patients with high-risk ALL (ALL-AR-11), with: Prednisone (PDN) 60 mg/m2, PO or IV until complete characterisation of the ALL, for a maximum of 7 days, Triple intrathecal therapy, Methotrexate (MTX) 12 mg, ARA-C: 30 mg, Hydrocortisone 20 mg.
Standard induction chemotherapy that these patients receive according to routine clinical practice at Spanish sites, in accordance with the PETHEMA protocol for patients with high-risk ALL (ALL-AR-11), consists of: Vincristine (VCR) 1.5 mg/m2 (maximum dose 2 mg) IV days 1, 8, 15 and 22,Daunorubicin (DNR) 45 mg/m2 IV days 1, 8, 15 and 22, prednisone 60 mg/m2 per day, IV or PO, days 1 to 14,30 mg/m2 per day, IV or PO, days 15 to 21, 15 mg/m2 per day, IV or PO, days 21 to 28,E. coli L-asparaginase (L-ASP) (Kidrolase®) 10,000 IU/m2, IV, days 16-20, 23-27,Intrathecal TIT chemotherapy day 1* (if not administered in the pre-phase) and 22, Methotrexate (MTX) 12 mg, ARA-C: 30 mg, Hydrocortisone 20 mg, G-CSF (SC or IV) from day 15 until neutrophils > 1000/µl.
Following the administration of induction therapy, a bone marrow analysis will be performed with morphological, genetic and molecular study if necessary, with a centralised MRD determination by MFC. In the case of a complete morphological response and MRD < 0.1% (< 1×10-3), the patient will be enrolled in the trial and receive consolidation and maintenance treatment according to protocol.
Consolidation - CYCLE 1 Early consolidation chemotherapy that the patients will receive in the first cycle (21 days) consists of: dexamethasone 20 mg/m2 per day, PO or IV days 1-5, 10 mg/m2 per day, PO or IV day 6, 5 mg/m2 per day, PO or IV day 7, 2.5 mg/m2 per day, PO or IV day 8, Vincristine 1.5 mg/m2 per day, IV (maximum 2 mg) days 1 and 8, Methotrexare 3g/m2, IV in 24 hours, E. coli L-asparaginase (L-ASP) (Kidrolase®): 20,000 IU/m2, IV, day 3,Triple intrathecal therapy day 1.
Consolidation - CYCLE 2
Early consolidation chemotherapy that the patient will receive in the second cycle (21 days) consists of:
- Dexamethasone:
- 20 mg/m2 per day, PO or IV days 1-5.
- 10 mg/m2 per day, PO or IV day 6.
- 5 mg/m2 per day, PO or IV day 7.
- 2.5 mg/m2 per day, PO or IV day 8.
- ARA-C:
- 2 g/m2 every 12 hours, over 3 hours, days 1 and 2. Halve the ARA-C for patients over 50 years of age.
- E. coli L-asparaginase (L-ASP) (Kidrolase®): 20,000 IU/m2, IV, day 3. Halve the dose for patients over 50 years of age as the toxicity of any type of ASP increases with age.
- Triple intrathecal therapy day 4 (administered that day to keep the intrathecal therapy separate from the high-dose ARA-C).
Consolidation - CYCLE 3 In the third early consolidation cycle, the investigational drug blinatumomab will be administered.
- Blinatumomab 28 μg/day as a continuous infusion, IV over 4 weeks.
- Triple intrathecal therapy day 1.
Late consolidation Two weeks after completing the blinatumomab treatment, in the case of MRD < 0.01% (< 1×10-4), patients will receive 2 blocks of intensive chemotherapy (identical to those in early consolidation), separated by 3 weeks, followed by a treatment cycle with blinatumomab, the investigational medicinal product, for 4 weeks.
After administering late consolidation therapy, a bone marrow study will be conducted. In the case of MRD < 0.01% (< 1×10-4), the patient will receive maintenance treatment. If this MRD level is not achieved, the patient will be withdrawn from the study and undergo a haematopoietic stem cell transplantation, according to routine clinical practice at Spanish sites.
The maintenance therapy that patients will receive in this phase of the trial will consist of continuous chemotherapy administration (mercaptopurine and methotrexate) with reinductions for up to one year from CR
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| blinatumomab | Experimental | Drug: blinatumomabblinatumomab administered during the early consolidation phase in patients ≤ 55 years with high-risk Philadelphia chromosome-negative (Ph-) acute lymphoblastic leukaemia (ALL) with MRD < 0.1% (< 1×10-3) after induction therapy. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Men and women between 18 to 55 years of age, both inclusive.
- Patients with Philadelphia chromosome-negative or BCR-ABL-negative, CD19-positive ALL, with high-risk characteristics. The definition of high-risk ALL implies the presence of one or more of the following factors: Aged 30-55 years; Leukocytes > 30×109/l in B-precursor ALL; Any of the following cytogenetic or molecular abnormalities: 11q23 abnormalities, or proven MLL rearrangement; Complex karyotype (more than 5 chromosome abnormalities); Pro-B ALL, regardless of the number of leukocytes.
- Previous treatment according to routine clinical practice in Spanish centres, in accordance with the PETHEMA protocol for patients with high-risk ALL (ALL-AR-11), in complete remission (MRD < 0.1%) (< 1×10-3) centralised assessment through flow cytometry) after induction therapy.
- ECOG < 2.
- Ability to understand the study and willingness to sign the written informed consent form
Key exclusion criteria (20 listed)
- Philadelphia chromosome-positive (Ph+) ALL.
- Burkitt's leukaemia (mature B phenotype) according to the WHO classification.
- T-cell ALL.
- B-precursor ALL with high-risk characteristics and MRD ≥ 0.1% (≥ 1×10-3) after receiving induction chemotherapy.
- Previous history or presence of a clinically significant disease of the central nervous system (CNS): epilepsy, seizures, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, psychosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blinatumomabBlinatumomab is a bispecific monoclonal antibody designed to bind specifically to CD19, expressed on the surface of B-cells, and to CD3, expressed on the surface of T-cells. It activates endogenous T-cells by connecting the CD3 on the T-cell receptor complex (TCR) with the CD19 on the B-cells. The anti-tumour activity of blinatumomab does not depend on whether the T-cells carry a specific TCR or peptide antigens present in cancer cells, but it is polyclonal and independent of HLA on the target cells | Drug | blinatumomab |
Primary outcome
To assess the reduction rate of the Minimal residual disease determined by Multiparametric flow cytometry
Time frame: 1 year
To assess the reduction rate of the MRD determined by MFC, after early consolidation following the inclusion of blinatumomab administered during the early consolidation phase in patients ≤ 55 years of age with high-risk Philadelphia chromosome-negative (Ph-) acute lymphoblastic leukaemia (ALL) with MRD < 0.1% (< 1×10-3) after induction therapy.
Results and safety
The study was stopped early (reason given: Low rate of recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2022.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing blinatumomab in people with Philadelphia Chromosome-negative or BCR-ABL-negative, CD19-positive ALL, run by PETHEMA Foundation at 12 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Low rate of recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the reduction rate of the Minimal residual disease determined by Multiparametric flow cytometry (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2022.