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Status:

TERMINATED

Blinatumomab for MRD in Pre-B ALL Patients Following Stem Cell Transplant

Lead Sponsor:

University of British Columbia

Collaborating Sponsors:

Amgen

Conditions:

B-cell Adult Acute Lymphoblastic Leukemia

Stem Cell Leukemia

Eligibility:

All Genders

1+ years

Phase:

PHASE2

Brief 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 ce...

Eligibility Criteria

Inclusion

  • Testing Phase of Trial:
  • 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).
  • 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.

Exclusion

  • 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.
  • Treatment Phase of Trial:
  • Inclusion Criteria:
  • 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.

Key Trial Info

Start Date :

September 8 2020

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

February 2 2022

Estimated Enrollment :

8 Patients enrolled

Trial Details

Trial ID

NCT04044560

Start Date

September 8 2020

End Date

February 2 2022

Last Update

February 21 2022

Active Locations (3)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 1 (3 locations)

1

Vancouver General Hospital - Leukemia/Bone Marrow Transplant Program

Vancouver, British Columbia, Canada, V5Z1M9

2

BC Children's Hospital

Vancouver, British Columbia, Canada, V5Z4H4

3

QEII - Health Sciences Centre

Halifax, Nova Scotia, Canada, B3H 2Y9