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Status:

TERMINATED

ALL SCTped 2012 FORUM Add-on Study Blina Post HSCT

Lead Sponsor:

Prof. Christina Peters

Collaborating Sponsors:

Amgen

Conditions:

ALL, Childhood

Minimal Residual Disease

Eligibility:

All Genders

6-21 years

Phase:

PHASE2

Brief Summary

An add-on phase II trial within the ALL SCTped 2012 FORUM with the primary objective to determine whether the use of Blincyto in paediatric patients with B-lineage ALL and pre- and/or post-transplant ...

Detailed Description

6.2.1 Screening / Pretreatment\* The screening process begins on the date the subject (or legally acceptable representative) signs the IRB/EC approved ICF and assent form and continues until enrollmen...

Eligibility Criteria

Inclusion

  • Patients participating in ALL SCTped 2012 FORUM;
  • Age: \> 0.5 years and \< 21 years;
  • B-precursor ALL with \< 5% blasts in the bone marrow (M1 bone marrow) and CD19+ minimal residual disease (MRD) before and/or following allogeneic HSCT;
  • Indication for first allogeneic HSCT was CD19+ ALL in first, second or third remission;
  • Allogeneic Hematopoietic Stem Cell Transplant (HSCT): at first dose of Blincyto patients must be at least \> 60 days post-SCT and without evidence of grade 2 or higher acute GVHD and off systemic immunosuppression (tapering allowed) and at least 4 weeks after last donor lymphocyte infusion (DLI);
  • Performance-Status (Karnovsky/Lansky): above 50%;
  • Written consent of the parents/legal guardian and, if necessary, the minor patient via "Informed Consent Form";
  • No pregnancy;
  • No secondary malignancy.

Exclusion

  • Patients who do not fulfill the inclusion criteria;
  • The whole protocol or essential parts are declined either by patient himself/herself or the respective legal guardian;
  • Malformation syndromes;
  • Renal impairment (\< 30% of normal glomerular filtration rate);
  • Severe pulmonary, hepatic or cardiac impairment due to toxicity or infection (\> CTCAE grade 3);
  • Recent episode of seizures or posterior reversible encephalopathy syndrome in the past 30 days;

Key Trial Info

Start Date :

December 17 2020

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 22 2022

Estimated Enrollment :

3 Patients enrolled

Trial Details

Trial ID

NCT04785547

Start Date

December 17 2020

End Date

January 22 2022

Last Update

January 16 2024

Active Locations (14)

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

Page 1 of 4 (14 locations)

1

St. Anna Kinderspital

Vienna, Austria(AUT), Austria, 1090

2

University Hospital Gasthuisberg (UZ Leuven)

Leuven, Belgium

3

Motol University Hospital Prague

Prague, Czechia

4

Rigshospitalet Copenhagen

Copenhagen, Denmark