Clinical Trials /

Blinatumomab Maintenance Following Allogeneic Hematopoietic Cell Transplantation for Patients With Acute Lymphoblastic Leukemia

NCT02807883

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.

Related Conditions:
  • Acute Lymphoblastic Leukemia
  • B-Cell Acute Lymphoblastic Leukemia
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

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

DrugSynonymsArms
BlinatumomabBlincytoBlinatumomab

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

NameTypeDescriptionInterventions
BlinatumomabExperimentalBlinatumomab 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).
  • Blinatumomab

Eligibility Criteria

        Inclusion Criteria:

          1. Patients 18-70 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

        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:18 Years
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: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

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