Description:
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.
Title
- Brief Title: Blinatumomab Maintenance Following Allogeneic Hematopoietic Cell Transplantation for Patients With Acute Lymphoblastic Leukemia
- Official Title: Blinatumomab Maintenance Following Allogeneic Hematopoietic Cell Transplantation for Patients With Acute Lymphoblastic Leukemia
Clinical Trial IDs
- ORG STUDY ID:
2015-0576
- SECONDARY ID:
NCI-2016-01182
- NCT ID:
NCT02807883
Conditions
- Acute Lymphoblastic Leukemia
Interventions
| Drug | Synonyms | Arms |
|---|
| Blinatumomab | Blincyto | Blinatumomab |
Purpose
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.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| 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). | |
Eligibility Criteria
Inclusion Criteria:
1. Patients 1-70 years of age.
2. 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.
3. 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.
4. Performance status of 0, 1, or 2. Karnofsky (or Lansky for subjects < 16 years old)
performance status >/= 50.
Exclusion Criteria:
1. Relapsed ALL defined as >5% malignant blasts in bone marrow or peripheral blood.
2. Active GVHD requiring systemic steroid therapy. Medications for GVHD prophylaxis are
acceptable.
3. Systemic steroid therapy unless for physiologic replacement
4. Uncontrolled disease/infection as judged by the treating physician
5. 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
6. Pregnant or nursing women
| Maximum Eligible Age: | 70 Years |
| Minimum Eligible Age: | 1 Year |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Feasibility of Blinatumomab Maintenance Following Allogeneic Hematopoietic Cell Transplantation for Patients With Acute Lymphoblastic Leukemia |
| Time Frame: | 30 days |
| Safety Issue: | |
| Description: | Feasibility determined by 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. |
Secondary Outcome Measures
| Measure: | Progression Free Survival (PFS) |
| Time Frame: | 1 year |
| Safety Issue: | |
| Description: | PFS defined from date of allogeneic HCT to the date of disease progression or death. |
| Measure: | Overall Survival (OS) |
| Time Frame: | 1 year |
| Safety Issue: | |
| Description: | OS defined from date of allogeneic HCT to date of last known vital sign. |
Details
| Phase: | Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Active, not recruiting |
| Lead Sponsor: | M.D. Anderson Cancer Center |
Trial Keywords
- Acute Lymphoblastic Leukemia
- ALL
- B-lineage Acute Lymphoblastic Leukemia
- Malignant neoplasms stated as primary lymphoid haematopoietic
- Blinatumomab
- Blincyto
- Post allogeneic stem cell transplant
Last Updated
November 30, 2020
