B-cell Adult Acute Lymphoblastic LeukemiaPhase 2OZM-097NCT04044560
Blinatumomab for MRD in Pre-B ALL Patients Following Stem Cell Transplant
A Phase 2 study testing blinatumomab in people with B-cell Adult Acute Lymphoblastic Leukemia and Stem Cell Leukemia, run by University of British Columbia at 3 sites in Canada.
Trial summary
This is a single arm, open label, multi-centre phase II study using blinatumomab for treatment of detectable minimal residual disease (MRD) in the first year following allogeneic hematopoietic stem cell transplant (HSCT) for patients with B cell acute lymphoblastic leukemia (B-ALL). The study has 2 phases: 1. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- B-cell Adult Acute Lymphoblastic Leukemia, Stem Cell Leukemia, Minimal Residual Disease
- What is being tested?
- blinatumomab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 3 sitesCanada
- Study dates
- 8 Sep 2020to 2 Feb 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 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Pre-B-ALL in complete remission (CR), <5% blasts on most recent bone marrow aspirate determined by morphologic assessment, with an intention to proceed to allogeneic HSCT. Eligible participants can be in 1st CR or greater. Presence of detectable MRD by flow cytometry or other techniques in patients that are in morphologic remission prior to transplant is permitted.
- Detectable MRD measured by flow cytometry or other molecular techniques is acceptable for enrollment in patients with <5% blasts.
- Patients with either Philadelphia chromosome positive or negative B-ALL are eligible
- Documented expression of CD19 on the lymphoblast population as measured by flow-cytometry if patient has received prior CD19-directed therapy.
- Eligibility for HSCT along with conditioning regimen and donor selection will be determined according to the treating centre's policy.
- Patients must be age ≥1 years and have a baseline performance status of ECOG ≤ 2 (adult) or Lansky ≥ 50% (pediatric).
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- Patient with chronic hepatitis B (Hep B surface antigen or Hep B Core antibody reactive) are eligible if they are receiving treatment to prevent reactivation (e.g. lamivudine, tenofovir) and have undetectable serum Hepatitis B DNA
- Patients (or legally acceptable designate) must provide written consent.
- Female patients of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study from the time of informed consent signature date until 3 months after completion of study treatment. Patients of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year.
- Detectable MRD ≥ 10^-4 leukemic cells/TNC on a bone marrow aspirate done on day +56, +100, +180 or day +270.
- Morphologic remission on bone marrow from same date (on day +56, +100, +180 or day +270)
- Patients must be age ≥1 years and have a baseline performance status of ECOG ≤ 2 (adult) or Lansky ≥ 50% (pediatric) documented within 7 days of enrollment.
- Patients with either Philadelphia chromosome positive or negative B-ALL are eligible
- Documented expression of CD19 on the lymphoblast population as measured by flow-cytometry if patient has received prior CD19-directed therapy.
- Patient with chronic hepatitis B (Hep B surface antigen or Hep B Core antibody reactive) are eligible if they are receiving treatment to prevent reactivation (e.g. lamivudine, tenofovir) and have undetectable serum Hepatitis B DNA
- Adequate organ, liver and renal function including: Total bilirubin ≤ 1.5 x upper limit of normal (ULN), eGFR >30 mL/min/1.73 m, Alkaline phosphatase ≤ 2.5 x ULN, Serum lipase ≤ 1.5 x ULN
- Patients (or legally acceptable designate) must provide written consent.
Who cannot join
- Inability to comply with study procedures.
- Active central nervous system (CNS) involvement or other extramedullary disease at the time of enrollment.
- Uncontrolled infection until resolved.
- Burkitt lymphoma/leukemia or mixed phenotype leukemia.
- Chronic infection with Hepatitis C. Previously treated Hepatitis C with undetectable Hepatitis C RNA for six months or longer is acceptable.
- HIV 1/2 Infection.
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- Treatment Phase of Trial:
- Active acute GVHD (grade II-IV) or active moderate-severe chronic GVHD (NIH Grade) at the time of MRD detection are ineligible treatment phase until GVHD resolves or quiescent as determined by the treating physician.
- Uncontrolled infection until resolved.
- Chronic infection with Hepatitis C. Previously treated Hepatitis C with undetectable Hepatitis C RNA for six months or longer is acceptable.
- HIV 1/2 Infection.
- Extramedullary or CNS disease or the time of MRD detection.
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
QEII - Health Sciences Centre
Halifax, Nova Scotia, B3H 2Y9
Vancouver General Hospital - Leukemia/Bone Marrow Transplant Program
Vancouver, British Columbia, V5Z1M9
BC Children's Hospital
Vancouver, British Columbia, V5Z4H4
About this study
Official title: Blinatumomab for Minimal Residual Disease (MRD) in Pre-B Cell Acute Lymphoblastic Leukemia Patients Following Hematopoietic Cell Transplantation: A Canadian, Multicentre Trial
This is a single arm, open label, multi-centre phase II study using blinatumomab for treatment of detectable minimal residual disease (MRD) in the first year following allogeneic hematopoietic stem cell transplant (HSCT) for patients with B cell acute lymphoblastic leukemia (B-ALL). The study has 2 phases: 1. MRD testing phase and 2. blinatumomab treatment phase. Participants with B-ALL planning for HSCT meeting other eligibility criteria will be enrolled onto the MRD testing phase, which will involve centralized MRD testing of bone marrow aspirate samples on day +56, +100, +180, +270 following HSCT. Participants with detectable MRD ≥10^-4 leukemic cells/total nucleated cells will enroll onto the treatment phase. Blinatumomab treatment will be started following detection of MRD after 7 to 42 days from enrollment onto the treatment phase to allow for initiation of taper of immunosuppressive medications.
- Being tested
- blinatumomab
- Keywords
- acute lymphoblastic leukemia, blinatumomab, minimal residual disease, stem cell transplant
- Medical subject headings
- Leukemia, Biphenotypic, Acute, Neoplasm, Residual, Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blinatumomabBiological
Continuous intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| Blinatumomab Treatment | Experimental | Eligible patients with detectable MRD will taper immunosuppressive medications, if applicable, and undergo treatment with blinatumomab. The duration of each cycle of blinatumomab treatment is 6 weeks. Adult and pediatric patients will be treated for 4 weeks followed by a 2-week treatment free period. Patients may receive up to 4 cycles total of blinatumomab therapy. Receives: Biological: blinatumomab |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRD Response
To determine the proportion of patients with MRD response, defined as negative MRD as measured by flow cytometry, after 1 cycle of blinatumomab.
Measured: Following 1st cycle of blinatumomab (each cycle is 28 days)
Secondary outcomes (6)
Safety and Tolerability
Safety of delivering blinatumomab will be monitored early during the post-transplant course. Safety will be evaluated by the onset of treatment emergent adverse events (TEAEs) and by documentation of the incidence and severity of acute and chronic graft versus host disease (GvHD).
Measured: During Blinatumomab treatment, an average of 24 weeks
Survival
Clinically relevant survival outcomes for patients enrolled onto the study including: 2-year and 5-year overall survival (OS) and event free-survival (EFS) and median OS.
Measured: Up to 5 years
Incidence of MRD Post HSCT
To determine the proportion of patients developing detectable MRD following HSCT for B-ALL as measured by flow cytometry.
Measured: Up to day +270 following stem cell transplant
Patient Recruitment (Number of Patients Recruited)
Feasibility
Measured: Through Study Completion, an average of 2 years
Turnaround time of centralized MRD testing (days)
Feasibility
Measured: Through Study Completion, an average of 2 years
Time to delivery of blinatumomab following MRD detection
Feasibility
Measured: Through Study Completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2019
- Study start8 Sep 2020
- Primary completion2 Feb 2022
- Study completion2 Feb 2022
Why it stopped: Slow enrolment, loss of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B-cell Adult Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- 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
- Sequential
- Model description
- Participants will be monitored for MRD post transplant during the testing phase of the trial. If they have detectable MRD, they will be enrolled into the blinatumomab treatment phase.
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Amgen
- Responsible party
- Principal investigator, David Sanford, University of British Columbia
- Investigators
- David Sanford, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04044560
- Sponsor's protocol ID
- H19-00893
- Other IDs
- CTTC 1902
- Acronym
- OZM-097
- Status last verified
- Feb 2022
- First submitted
- 31 Jul 2019
- Last updated
- 21 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blinatumomab for Minimal Residual Disease (MRD) in Pre-B Cell Acute Lymphoblastic Leukemia Patients Following Hematopoietic Cell Transplantation: A Canadian, Multicentre Trial
- ClinicalTrials.gov ID
- NCT04044560
- Acronym / sponsor ID
- OZM-097 / H19-00893
- Keywords
- acute lymphoblastic leukemia, blinatumomab, minimal residual disease, stem cell transplant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow enrolment, loss of funding
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Amgen
- Study start
- 8 Sep 2020 (actual)
- Primary completion
- 2 Feb 2022 (actual)
- Study completion
- 2 Feb 2022 (actual)
- First posted
- 5 Aug 2019 (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.
This is a single arm, open label, multi-centre phase II study using blinatumomab for treatment of detectable minimal residual disease (MRD) in the first year following allogeneic hematopoietic stem cell transplant (HSCT) for patients with B cell acute lymphoblastic leukemia (B-ALL). The study has 2 phases: 1. MRD testing phase and 2. blinatumomab treatment phase. Participants with B-ALL planning for HSCT meeting other eligibility criteria will be enrolled onto the MRD testing phase, which will involve centralized MRD testing of bone marrow aspirate samples on day +56, +100, +180, +270 following HSCT. Participants with detectable MRD ≥10^-4 leukemic cells/total nucleated cells will enroll onto the treatment phase. Blinatumomab treatment will be started following detection of MRD after 7 to 42 days from enrollment onto the treatment phase to allow for initiation of taper of immunosuppressive medications.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants will be monitored for MRD post transplant during the testing phase of the trial. If they have detectable MRD, they will be enrolled into the blinatumomab treatment phase.
| Arm | Type | Receives |
|---|---|---|
| Blinatumomab Treatment | Experimental | Biological: blinatumomabEligible patients with detectable MRD will taper immunosuppressive medications, if applicable, and undergo treatment with blinatumomab. The duration of each cycle of blinatumomab treatment is 6 weeks. Adult and pediatric patients will be treated for 4 weeks followed by a 2-week treatment free period. Patients may receive up to 4 cycles total of blinatumomab therapy. |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (17 listed)
- Pre-B-ALL in complete remission (CR), <5% blasts on most recent bone marrow aspirate determined by morphologic assessment, with an intention to proceed to allogeneic HSCT. Eligible participants can be in 1st CR or greater. Presence of detectable MRD by flow cytometry or other techniques in patients that are in morphologic remission prior to transplant is permitted.
- Detectable MRD measured by flow cytometry or other molecular techniques is acceptable for enrollment in patients with <5% blasts.
- Patients with either Philadelphia chromosome positive or negative B-ALL are eligible
- Documented expression of CD19 on the lymphoblast population as measured by flow-cytometry if patient has received prior CD19-directed therapy.
- Eligibility for HSCT along with conditioning regimen and donor selection will be determined according to the treating centre's policy.
Key exclusion criteria (12 listed)
- Inability to comply with study procedures.
- Active central nervous system (CNS) involvement or other extramedullary disease at the time of enrollment.
- Uncontrolled infection until resolved.
- Burkitt lymphoma/leukemia or mixed phenotype leukemia.
- Chronic infection with Hepatitis C. Previously treated Hepatitis C with undetectable Hepatitis C RNA for six months or longer is acceptable.
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 |
|---|---|---|
| blinatumomabContinuous intravenous infusion | Biological | Blinatumomab Treatment |
Primary outcome
MRD Response
Time frame: Following 1st cycle of blinatumomab (each cycle is 28 days)
To determine the proportion of patients with MRD response, defined as negative MRD as measured by flow cytometry, after 1 cycle of blinatumomab.
6 secondary outcomes
Safety and Tolerability
Time frame: During Blinatumomab treatment, an average of 24 weeks
Survival
Time frame: Up to 5 years
Incidence of MRD Post HSCT
Time frame: Up to day +270 following stem cell transplant
Patient Recruitment (Number of Patients Recruited)
Time frame: Through Study Completion, an average of 2 years
Turnaround time of centralized MRD testing (days)
Time frame: Through Study Completion, an average of 2 years
Time to delivery of blinatumomab following MRD detection
Time frame: Through Study Completion, an average of 2 years
Results and safety
The study was stopped early (reason given: Slow enrolment, loss of funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2022.
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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.
David Sanford, MD principal investigator
University of British Columbia
3 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 B-cell Adult Acute Lymphoblastic Leukemia and Stem Cell Leukemia, run by University of British Columbia at 3 sites in Canada.
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 17 inclusion and 12 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 21 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. 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: Slow enrolment, loss of funding). 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?
MRD Response (time frame: Following 1st cycle of blinatumomab (each cycle is 28 days)). 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 21 Feb 2022.