Acute Lymphoblastic LeukemiaPhase 2NCT02807883
Blinatumomab Maintenance Following Allogeneic Hematopoietic Cell Transplantation for Patients With Acute Lymphoblastic Leukemia
A Phase 2 study testing Blinatumomab and Hematopoietic Cell Transplantation in people with Acute Lymphoblastic Leukemia, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
You are being asked to take part in this study because you either had Ph positive B-lineage acute lymphoblastic leukemia (ALL) or still have a small amount of the disease and recently received an allogeneic stem cell transplant (cells from someone else). Read more about this study
- Who is it for?
- Ages 1 year to 70 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia
- What is being tested?
- Blinatumomab and Hematopoietic Cell Transplantation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to 1 Feb 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients 1-70 years of age.
- Patients with B-lineage ALL in a) hematologic complete remission (CR) beyond CR1 at time of transplant; patients beyond CR1 or with primary induction failure may be without minimal residual disease, b) any residual disease defined by positive flow >0.01%, detection of BCR-ABL transcript by PCR with a sensitivity of 1/10,000, or detection of the t(9;22) translocation in any metaphases by cytogenetics at time of transplant, or presence of the MLL gene.
- Received an allogeneic HCT within the last 100 days. Enrollment within 30-100 days after transplant, and after adequate recovery of counts defined as ANC >/= 0.5 x 10^9/L without daily use of myeloid growth factor and platelet > 20 x 10^9/L without platelet transfusion within 1 week, and adequate organ function to receive blinatumomab defined as creatinine clearance greater than 30 ml/min, ALT/AST < 5 x ULN and serum bilirubin < 3 x ULN.
- Performance status of 0, 1, or 2. Karnofsky (or Lansky for subjects < 16 years old) performance status >/= 50.
Who cannot join
- Relapsed ALL defined as >5% malignant blasts in bone marrow or peripheral blood.
- Active GVHD requiring systemic steroid therapy. Medications for GVHD prophylaxis are acceptable.
- Systemic steroid therapy unless for physiologic replacement
- Uncontrolled disease/infection as judged by the treating physician
- Active ALL in the central nervous system (CNS), as defined by >/= 5 leukocytes per microL with identifiable blast cells in the CSF, and/or the presence of cranial-nerve palsies
- Pregnant or nursing women
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
You are being asked to take part in this study because you either had Ph positive B-lineage acute lymphoblastic leukemia (ALL) or still have a small amount of the disease and recently received an allogeneic stem cell transplant (cells from someone else).
The goal of this clinical research study is to learn if blinatumomab in patients who have had an allogeneic stem cell transplant can help to control ALL or prevent ALL from coming back in patients who either have a small amount of ALL or have had ALL in the past. The safety of this drug will also be studied.
Read the detailed description
Study Drug Administration:
Every study cycle will be 6 weeks. You may receive up to 4 cycles of blinatumomab. Each cycle will start around 3, 6, 9, and 12 months after your stem cell transplant.
In each cycle, you will receive blinatumomab as a continuous infusion by vein for 4 weeks, followed by a 2 week "rest period" during which you will not receive blinatumomab.
You will need to remain in the hospital for the first 2 cycles so that you can be checked on for side effects.
Length of Study:
You may receive blinatumomab for up to 1 year. You will no longer be able to receive the study drug if the disease comes back (if you do not have ALL), if the disease gets worse (if you have a small amount of ALL), if intolerable side effects occur, or if you are unable to follow study directions.
Study Visits:
Before each cycle:
- You will have a physical exam. As part of the physical exam, you will be checked for graft versus host disease (GVHD, when transplanted donor tissue attacks the tissues of the recipient's body).
- Blood (about 4 tablespoons) will be drawn to learn the effectiveness of the stem cell transplant.
- You will have a bone marrow biopsy and aspiration to check the status of the disease and for cytogenetic testing.
Once a week during each cycle, blood (about 4 tablespoons) will be drawn for routine tests.
End of Study Visit:
About 2 weeks after your last dose of blinatumomab:
- You will have a physical exam.
- Blood (about 4 tablespoons) will be drawn to learn the effectiveness of the stem cell transplant.
- You will have a bone marrow biopsy and aspiration to check the status of the disease and for cytogenetic testing.
This is an investigational study. Blinatumomab is FDA approved and commercially available for the treatment of Philadelphia chromosome (Ph) negative B-ALL that has returned after treatment. Its use in patients with Ph positive B-lineage ALL is investigational.
Up to 30 participants will be enrolled in this study. All will take part at MD Anderson.
- Conditions
- Acute Lymphoblastic Leukemia
- Being tested
- Blinatumomab, Hematopoietic Cell Transplantation
- Keywords
- Acute Lymphoblastic Leukemia, ALL, B-lineage Acute Lymphoblastic Leukemia, Malignant neoplasms stated as primary lymphoid haematopoietic, Blinatumomab, Blincyto, Post allogeneic stem cell transplant
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BlinatumomabDrug
Also called Blincyto
Participants receive Blinatumomab as continuous intravenous infusion at a dose of 28 µg/24 hours over 4 weeks followed by a treatment-free period of 2 weeks, defined as one 6-week treatment cycle. In the first induction cycle, the initial dose of Blinatumomab is 9 µg/day for the first 7 days of treatment which then will be escalated (dose step) to 28 µg/day starting on day 8 (week 2) through day 29 (week 4). For all subsequent cycles, 28 µg/day is the dose for all 4 weeks of continuous treatment. Participants receive 4 cycles of blinatumomab at 3, 6, 9, and 12 months following hematopoietic cell transplantation (HCT).
Hematopoietic Cell TransplantationProcedure or surgery
Also called HCT
Hematopoietic progenitor cell infusion
| Study group | Role | What they receive |
|---|---|---|
| Blinatumomab | Experimental | Blinatumomab as continuous intravenous infusion at dose of 28 µg/24 hours over 4 weeks followed by 2 week treatment-free period for 6-week treatment cycle; 4 cycles of blinatumomab at 3, 6, 9, and 12 months following hematopoietic cell transplantation (HCT). Receives: Drug: Blinatumomab; Procedure: Hematopoietic Cell Transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Toxicities
Participants with treatment-related toxicities attributable to Blinatumomab. Toxicities defined as any 1) grade 3-4 acute GVHD greater than 30%, 2) secondary graft failure >30%, or 3) nonrelapse mortality (NRM) within one cycle of Blinatumomab.
Measured: 30 days from the first cycle
Secondary outcomes (2)
Progression Free Survival (PFS)
Number of participants with progression free survival from the date of allogeneic HCT to the date of disease progression or death. (Progression is defined as more than 5% blast in the peripheral blood or bone marrow biopsy.)
Measured: From last treatment cycle, assessed up to 1 year
Overall Survival (OS)
Number of participants in the study who are alive and disease free up to 1 year.
Measured: From last treatment cycle, assessed up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2016 (estimated)
- Study startAug 2016
- Primary completion1 Feb 2022
- Study completion1 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Amgen
- Responsible party
- Sponsor
- Investigators
- Partow Kebriaei, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02807883
- Sponsor's protocol ID
- 2015-0576
- Other IDs
- NCI-2016-01182
- Status last verified
- Dec 2022
- First submitted
- 17 Jun 2016
- Last updated
- 20 Jan 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Gaballa MR, Banerjee P, Milton DR, Jiang X, Ganesh C, Khazal S, Nandivada V, Islam S, Kaplan M, Daher M, Basar R, Alousi A, Mehta R, Alatrash G, Khouri I, Oran B, Marin D, Popat U, Olson A, Tewari P, Jain N, Jabbour E, Ravandi F, Kantarjian H, Chen K, Champlin R, Shpall E, Rezvani K, Kebriaei P. Blinatumomab maintenance after allogeneic hematopoietic cell transplantation for B-lineage acute lymphoblastic leukemia. Blood. 2022 Mar 24;139(12):1908-1919. doi: 10.1182/blood.2021013290.
PubMed 34914826
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blinatumomab Maintenance Following Allogeneic Hematopoietic Cell Transplantation for Patients With Acute Lymphoblastic Leukemia
- ClinicalTrials.gov ID
- NCT02807883
- Acronym / sponsor ID
- 2015-0576
- Conditions
- Acute Lymphoblastic Leukemia
- Keywords
- Acute Lymphoblastic Leukemia, ALL, B-lineage Acute Lymphoblastic Leukemia, Malignant neoplasms stated as primary lymphoid haematopoietic, Blinatumomab, Blincyto, Post allogeneic stem cell transplant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Amgen
- Study start
- Aug 2016 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 21 Jun 2016 (estimated)
- Results
- Posted 20 Jan 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
You are being asked to take part in this study because you either had Ph positive B-lineage acute lymphoblastic leukemia (ALL) or still have a small amount of the disease and recently received an allogeneic stem cell transplant (cells from someone else).
The goal of this clinical research study is to learn if blinatumomab in patients who have had an allogeneic stem cell transplant can help to control ALL or prevent ALL from coming back in patients who either have a small amount of ALL or have had ALL in the past. The safety of this drug will also be studied.
Detailed description
Study Drug Administration:
Every study cycle will be 6 weeks. You may receive up to 4 cycles of blinatumomab. Each cycle will start around 3, 6, 9, and 12 months after your stem cell transplant.
In each cycle, you will receive blinatumomab as a continuous infusion by vein for 4 weeks, followed by a 2 week "rest period" during which you will not receive blinatumomab.
You will need to remain in the hospital for the first 2 cycles so that you can be checked on for side effects.
Length of Study:
You may receive blinatumomab for up to 1 year. You will no longer be able to receive the study drug if the disease comes back (if you do not have ALL), if the disease gets worse (if you have a small amount of ALL), if intolerable side effects occur, or if you are unable to follow study directions.
Study Visits:
Before each cycle:
- You will have a physical exam. As part of the physical exam, you will be checked for graft versus host disease (GVHD, when transplanted donor tissue attacks the tissues of the recipient's body).
- Blood (about 4 tablespoons) will be drawn to learn the effectiveness of the stem cell transplant.
- You will have a bone marrow biopsy and aspiration to check the status of the disease and for cytogenetic testing.
Once a week during each cycle, blood (about 4 tablespoons) will be drawn for routine tests.
End of Study Visit:
About 2 weeks after your last dose of blinatumomab:
- You will have a physical exam.
- Blood (about 4 tablespoons) will be drawn to learn the effectiveness of the stem cell transplant.
- You will have a bone marrow biopsy and aspiration to check the status of the disease and for cytogenetic testing.
This is an investigational study. Blinatumomab is FDA approved and commercially available for the treatment of Philadelphia chromosome (Ph) negative B-ALL that has returned after treatment. Its use in patients with Ph positive B-lineage ALL is investigational.
Up to 30 participants will be enrolled in this study. All will take part at MD Anderson.
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: Blinatumomab, Procedure: Hematopoietic Cell TransplantationBlinatumomab as continuous intravenous infusion at dose of 28 µg/24 hours over 4 weeks followed by 2 week treatment-free period for 6-week treatment cycle; 4 cycles of blinatumomab at 3, 6, 9, and 12 months following hematopoietic cell transplantation (HCT). |
Who may qualify
- Ages
- 1 year to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients 1-70 years of age.
- Patients with B-lineage ALL in a) hematologic complete remission (CR) beyond CR1 at time of transplant; patients beyond CR1 or with primary induction failure may be without minimal residual disease, b) any residual disease defined by positive flow >0.01%, detection of BCR-ABL transcript by PCR with a sensitivity of 1/10,000, or detection of the t(9;22) translocation in any metaphases by cytogenetics at time of transplant, or presence of the MLL gene.
- Received an allogeneic HCT within the last 100 days. Enrollment within 30-100 days after transplant, and after adequate recovery of counts defined as ANC >/= 0.5 x 10^9/L without daily use of myeloid growth factor and platelet > 20 x 10^9/L without platelet transfusion within 1 week, and adequate organ function to receive blinatumomab defined as creatinine clearance greater than 30 ml/min, ALT/AST < 5 x ULN and serum bilirubin < 3 x ULN.
- Performance status of 0, 1, or 2. Karnofsky (or Lansky for subjects < 16 years old) performance status >/= 50.
Key exclusion criteria (6 listed)
- Relapsed ALL defined as >5% malignant blasts in bone marrow or peripheral blood.
- Active GVHD requiring systemic steroid therapy. Medications for GVHD prophylaxis are acceptable.
- Systemic steroid therapy unless for physiologic replacement
- Uncontrolled disease/infection as judged by the treating physician
- Active ALL in the central nervous system (CNS), as defined by >/= 5 leukocytes per microL with identifiable blast cells in the CSF, and/or the presence of cranial-nerve palsies
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 |
|---|---|---|
| BlinatumomabAlso: BlincytoParticipants receive Blinatumomab as continuous intravenous infusion at a dose of 28 µg/24 hours over 4 weeks followed by a treatment-free period of 2 weeks, defined as one 6-week treatment cycle. In the first induction cycle, the initial dose of Blinatumomab is 9 µg/day for the first 7 days of treatment which then will be escalated (dose step) to 28 µg/day starting on day 8 (week 2) through day 29 (week 4). For all subsequent cycles, 28 µg/day is the dose for all 4 weeks of continuous treatment. Participants receive 4 cycles of blinatumomab at 3, 6, 9, and 12 months following hematopoietic cell transplantation (HCT). | Drug | Blinatumomab |
| Hematopoietic Cell TransplantationAlso: HCTHematopoietic progenitor cell infusion | Procedure or surgery | Blinatumomab |
Primary outcome
Number of Participants With Toxicities
Time frame: 30 days from the first cycle
Participants with treatment-related toxicities attributable to Blinatumomab. Toxicities defined as any 1) grade 3-4 acute GVHD greater than 30%, 2) secondary graft failure >30%, or 3) nonrelapse mortality (NRM) within one cycle of Blinatumomab.
2 secondary outcomes
Progression Free Survival (PFS)
Time frame: From last treatment cycle, assessed up to 1 year
Overall Survival (OS)
Time frame: From last treatment cycle, assessed up to 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34914826Gaballa MR, Banerjee P, Milton DR, Jiang X, Ganesh C, Khazal S, Nandivada V, Islam S, Kaplan M, Daher M, Basar R, Alousi A, Mehta R, Alatrash G, Khouri I, Oran B, Marin D, Popat U, Olson A, Tewari P, Jain N, Jabbour E, Ravandi F, Kantarjian H, Chen K, Champlin R, Shpall E, Rezvani K, Kebriaei P. Blinatumomab maintenance after allogeneic hematopoietic cell transplantation for B-lineage acute lymphoblastic leukemia. Blood. 2022 Mar 24;139(12):1908-1919. doi: 10.1182/blood.2021013290.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
Partow Kebriaei, MD principal investigator
M.D. Anderson Cancer Center
1 site 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 and Hematopoietic Cell Transplantation in people with Acute Lymphoblastic Leukemia, run by M.D. Anderson Cancer Center at 1 site in United States.
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 4 inclusion and 6 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: finished, as of the sponsor's last update on 20 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Yes. Results are posted in the registry (first posted 20 Jan 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Toxicities (time frame: 30 days from the first cycle). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02807883, which also lists 1 linked publication.
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 20 Jan 2023.