NCT02807883

Brief 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). 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Aug 2016

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 17, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 21, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2022

Completed
12 months until next milestone

Results Posted

Study results publicly available

January 20, 2023

Completed
Last Updated

January 20, 2023

Status Verified

December 1, 2022

Enrollment Period

5.5 years

First QC Date

June 17, 2016

Results QC Date

October 13, 2022

Last Update Submit

December 30, 2022

Conditions

Acute Lymphoblastic Leukemia

Keywords

Acute Lymphoblastic LeukemiaALLB-lineage Acute Lymphoblastic LeukemiaMalignant neoplasms stated as primary lymphoid haematopoieticBlinatumomabBlincytoPost allogeneic stem cell transplant

Outcome Measures

Primary Outcomes (1)

  • 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.

    30 days from the first cycle

Secondary Outcomes (2)

  • Progression Free Survival (PFS)

    From last treatment cycle, assessed up to 1 year

  • Overall Survival (OS)

    From last treatment cycle, assessed up to 1 year

Study Arms (1)

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).

Drug: BlinatumomabProcedure: Hematopoietic Cell Transplantation

Interventions

BlinatumomabDRUG

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).

Also known as: Blincyto
Blinatumomab
Hematopoietic Cell TransplantationPROCEDURE

Hematopoietic progenitor cell infusion

Also known as: HCT
Blinatumomab

Eligibility Criteria

Age1 Year - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • 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.

    PMID: 34914826DERIVED

Related Links

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

blinatumomabStem Cell Transplantation

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Cell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Results Point of Contact

Title
Partow Kebriaei, MD / Stem Cell Transplantation Department
Organization
University of Texas MD Anderson Cancer Center
pkebriae@mdanderson.org
713-745-0663

Study Officials

  • Partow Kebriaei, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2016

First Posted

June 21, 2016

Study Start

August 1, 2016

Primary Completion

February 1, 2022

Study Completion

February 1, 2022

Last Updated

January 20, 2023

Results First Posted

January 20, 2023

Record last verified: 2022-12

Locations

US(1)