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Therapy Protocol ALL SCT BFM International-Open, Multicenter, Controlled, Prospective Study for Therapy and Therapy Optimisation in Patients With Acute Lymphoblastic Leukemia (ALL) and an Indication for Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)


Phase 1/Phase 2
N/A
18 Years
Open (Enrolling)
Both
Acute Lymphoblastic Leukemia

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Trial Information

Therapy Protocol ALL SCT BFM International-Open, Multicenter, Controlled, Prospective Study for Therapy and Therapy Optimisation in Patients With Acute Lymphoblastic Leukemia (ALL) and an Indication for Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)


Inclusion Criteria:



all patients with ALL (except for patients with B-ALL) who fulfil the following criteria:

- age at time of initial diagnosis or relapse diagnosis, respectively

≤18 years

- indication for allogeneic HSCT

- complete remission (CR) is achieved before SCT

- written consent of the parents (legal guardian) and, if indicated, 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:

- not signed inform consent of the parents (legal guardian)

- pregnancy

- secondary malignancy

- previous HSCT

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

event-free and overall survival after allogeneic HSCT, occurrence of acute and chronic Graft-versus-Host-Disease (GvHD), occurrence and course of late effects after chemotherapy with subsequent allogeneic HSCT

Outcome Time Frame:

11 years

Safety Issue:

Yes

Authority:

Israel: Ministry of Health

Study ID:

ALL-SCT-BFM-0321-08-HMO-CTIL

NCT ID:

NCT00861679

Start Date:

January 2007

Completion Date:

September 2014

Related Keywords:

  • Acute Lymphoblastic Leukemia
  • HSCT
  • ALL
  • GvHD
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma

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