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Allogeneic Stem Cell Transplantation in Children and Adolescents With Acute Lymphoblastic Leukaemia


Phase 3
3 Months
18 Years
Open (Enrolling)
Both
Lymphoblastic Leukemia, Acute, Childhood;

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Trial Information

Allogeneic Stem Cell Transplantation in Children and Adolescents With Acute Lymphoblastic Leukaemia


Patients with high risk or relapsed acute lymphoblastic leukaemia (ALL) have a worse
prognosis compared to all other patients with ALL. For these patients additional therapy
approaches are required after they have achieved remission with multimodal chemotherapy.
Allogeneic haematopoetic stem cell transplantation shows promising results mainly due to an
immunological antileukaemic control by the graft-versus-leukaemia effect, but treatment
related mortality and morbidity remains a serious problem.


Inclusion Criteria:



- age at time of initial diagnosis or relapse diagnosis, respectively under or equal 18
years

- indication for allogeneic HSCT

- complete remission before HSCT

- written consent of the parents (legal guardian) and, if necessary, the minor patient
via Informed Consent Form

- no pregnancy

- no secondary malignancy

- no previous HSCT

- HSCT is performed in a study participating centre.

Exclusion Criteria:

- age at time of initial diagnosis or relapse diagnosis, respectively above 18 years

- no indication for allogeneic HSCT

- no complete remission before SCT

- no written consent of the parents (legal guardian) and, if necessary, the minor
patient via Informed Consent Form

- pregnancy

- secondary malignancy

- previous HSCT

- HSCT is not performed in a study participating centre.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Event-free and overall survival after allogeneic HSCT

Outcome Time Frame:

14 years

Safety Issue:

Yes

Principal Investigator

Arend v. Stackelberg, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

ALL-REZ BFM Study Center Berlin Germany

Authority:

Austria: Federal Ministry for Health Family and Youth

Study ID:

ALL-SZT- BFM 2003

NCT ID:

NCT01423747

Start Date:

July 2003

Completion Date:

September 2016

Related Keywords:

  • Lymphoblastic Leukemia, Acute, Childhood;
  • ALL
  • HSCT
  • children
  • adolescents
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma

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