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

Completed

• Conditions: T-cell Acute Lymphoblastic Leukemia

• Registration Number: NCT01950286
• Lead Sponsor: Region Örebro County

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.

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 Timeline

• Study Start: 2002-10
• Primary Completion: 2013-02
• Status Verified: 2013-09
• Study First Submitted: 2013-09-07
• Study First Submitted QC: 2013-09-21
• Last Update Submitted: 2013-09-21
• Study First Posted: 2013-09-25
• Last Update Posted: 2013-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

all patients with T-ALL diagnosis

Exclusion Criteria

no

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Orebro University Hospital; 🇸🇪 Orebro, Orebro county, Sweden