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Comparative Evaluation of Results of Allogeneic Hematopoietic Stem Cells Versus Ponatinib in CML Patients Carrying a Mutation T315I

Civil Hospices of Lyon logo

Civil Hospices of Lyon

Status

Completed

Conditions

Leukemia

Treatments

Drug: Ponatinib (Iclusig®)
Procedure: allogeneic stem cell transplantation

Study type

Observational

Funder types

Other

Identifiers

NCT02981784
69HCL16_0716

Details and patient eligibility

About

Effective treatment options for chronic myeloid leukemia (CML) or Philadelphia-positive (Ph+) acute lymphoblastic leukemia (ALL) patients with the T315I mutation are few. This study compared overall survival (OS) between CML and Ph+ ALL patients treated with ponatinib versus allogeneic stem cell transplantation (allo-SCT).

Enrollment

184 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • CML any phase with T315I mutation
  • Ph+ ALL with a T315I mutation
  • Being treated in the PACE trial according to the criteria of this phase II trial
  • Or being allogeneic stem cell transplanted with any source of allogeneic cells and after any conditioning regimen.

Exclusion criteria

  • Ph negative patients
  • Patients under 18 years

Trial design

184 participants in 2 patient groups

Ponatinib (PACE trial)
Description:
PACE trial : "Ponatinib for Chronic Myeloid Leukemia (CML) Evaluation and Ph+ Acute Lymphoblastic Leukemia (ALL)", NCT01207440
Treatment:
Drug: Ponatinib (Iclusig®)
Allogenis stem cell transplantation (EBMT registry)
Description:
EBMT : European Group for Blood and Marrow Transplantation
Treatment:
Procedure: allogeneic stem cell transplantation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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