Hyper-CVAD Treatment of Adult T-cell Acute Lymphoblastic Leukemia in Sweden.

Sponsor

Region Örebro County (Other)

Overall Status

Completed

CT.gov ID

NCT01950286

Collaborator

(none)

Enrollment

Location

Study Details

Study Description

Brief Summary

Hyper-CVAD (a chemotherapy regimen) has shown promising results in adult T-cell Acute Lymphoblastic Leukemia (T-ALL). Patients with T-ALL diagnosis were reported to the Swedish Adult Acute Leukemia Registry between October 2002 and September 2006. Hyper-CVAD was recommended to all patients without severe comorbidity. Allogeneic stem cell transplantation was recommended for patients with high-risk disease. The aim of this population-based study was to assess the efficacy of Hyper-CVAD treatment.

Condition or Disease	Intervention/Treatment	Phase
T-cell Acute Lymphoblastic Leukemia

Detailed Description

Patients with T-ALL diagnosis were prospectively reported to the Swedish Adult Acute Leukemia Registry between October 2002 and September 2006. Missing data were complemented retrospectively. Hyper-CVAD (fractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone alternating with cycles of high-dose methotrexate and cytarabine) was recommended to all patients without severe comorbidity. Allogeneic stem cell transplantation (SCT) was recommended for patients with high-risk disease: white blood cell count >100×109/L, complete remission (CR) achievement after more than two courses, high minimal residual disease level, and relapsed disease (after CR2 achievement). In patients without high-risk factors maintenance therapy was given with per oral mercaptopurine and methotrexate for two years including reinduction courses: daunorubicine, vincristine and prednisolone every second month (1st year) and cytarabine, thioguanine and prednisolone every third month (2nd year).

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

24 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Four Years Experience With Hyper-CVAD Treatment of Adult T-cell Acute Lymphoblastic Leukemia in Sweden. Population-based Data.

Study Start Date :

Oct 1, 2002

Actual Primary Completion Date :

Feb 1, 2013

Outcome Measures

Primary Outcome Measures

overall survival [The outcome was assesed from T-ALL diagnosis to date of death or last follow-up (up to 125 months). Diagnosis was made between October 2002 and September 2006. All surviving patients were followed up until February 2013.]
Overall survival was defined as time from T-ALL diagnosis to the date of death from any cause or the date of last follow-up. All events (death/relapse) were reported prospectively to the the swedish acute leukemia registry. Inclusion Criteria: All patients with T-ALL diagnosis. Exclusion Criteria: No

Secondary Outcome Measures

leukemia free survival [The outcome was assesed from T-ALL diagnosis to date of death or last follow-up (up to 125 months). Diagnosis was made between October 2002 and September 2006. All surviving patients were followed up until February 2013.]
Leukemia free survival was defined as time from achievement of complete remission to the date of T-ALL relapse or date of death from any cause or date of last follow-up. All events (death/relapse) were reported prospectively to the the swedish acute leukemia registry. Inclusion Criteria: All patients with T-ALL diagnosis. Exclusion Criteria: No