Philadelphia Positive Acute Lymphoblastic Leukemia Clinical Trial
Official title:
Outcome of Hematopoietic Stem Cell Transplantation in Philadelphia Positive Acute Lymphoblastic Leukemia in the Era of Tyrosine Kinase Inhibitors. A Registry-based Study of the Italian Blood and Marrow Transplantation Society (GITMO)
NCT number | NCT03821727 |
Other study ID # | PRN°0068937 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 26, 2016 |
Est. completion date | June 30, 2018 |
Verified date | January 2019 |
Source | University Hospital, Udine, Italy |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
This study includes a registry-based, nationwide analysis to describe the clinical outcome of adult patients with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) who underwent an allogeneic hematopoietic stem cell transplantation (HSCT) after a Tyrosine Kinase Inhibitors (TKI)-based treatment.
Status | Completed |
Enrollment | 441 |
Est. completion date | June 30, 2018 |
Est. primary completion date | December 31, 2017 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Diagnosis of Ph+ ALL; age =18 years at transplant. - Patients receiving first allogeneic HSCT from any donor (HLA-identical sibling donor (MSD), unrelated donor (UD) or alternative donor (haploidentical or cord blood) between 2005 and 2016 in a GITMO center. - TKI-based treatment prior to HSCT. - Patients with available pre-transplant MRD status, as well as complete clinical data and outcome. Exclusion Criteria: - All cases without one or more of inclusion criteria. |
Country | Name | City | State |
---|---|---|---|
Italy | GITMO Centers and GITMO CLINICAL OFFICE-AOU-IRCSS San Martino-Ge | Genova | |
Italy | University Hospital, Udine | Udine |
Lead Sponsor | Collaborator |
---|---|
CANDONI ANNA | Gruppo Italiano Trapianto di Midollo Osseo |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Progression-free survival (PFS). | as reported | 5 years | |
Other | Cumulative incidence of relapse (CIR). | as reported | 5 years | |
Other | Non-relapse mortality (NRM). | as reported | 5 years | |
Primary | Overall Survival (OS). | as reported | 5 years | |
Secondary | Rate of complete cytologic remission (CR) before and after transplant. | As reported | Baseline and 3 months after SCT | |
Secondary | Rate of minimal residual disease (MRD). | As reported | Baseline and 3 months post SCT | |
Secondary | Cumulative incidence of extensive chronic graft versus host disease (cGVHD). | as reported | 5 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01724879 -
Study of Frontline Dasatinib Plus Chemotherapy in Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (PH+ALL)
|
Phase 2 | |
Recruiting |
NCT00199186 -
Study Comparing Imatinib With Chemotherapy as Induction in Elderly Patients With Philadelphia Positive Acute Lymphoblastic Leukemia (ALL)
|
Phase 2 | |
Recruiting |
NCT04260022 -
Study of HQP1351 in Subjects With Refractory CML and Ph+ ALL
|
Phase 1 | |
Completed |
NCT01914484 -
Phase I/II Study of Nilotinib/Ruxolitinb Therapy for TKI Resistant Ph-Leukemia
|
Phase 1/Phase 2 |