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

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

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.

Study Overview

• Status: Completed
• Conditions: 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 Type: Observational
• Enrollment (Actual): 24

Contacts and Locations

Study Locations

• Sweden
  • Orebro county
    • Orebro, Orebro county, Sweden, 70185
      • Orebro University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with T-ALL diagnosis reported to the Swedish Adult Acute Leukemia Registry between October 2002 and September 2006

Description

Inclusion Criteria: all patients with T-ALL diagnosis

Exclusion Criteria: no

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
overall survival	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	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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
leukemia free survival	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	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.

Collaborators and Investigators

• Sponsor: Region Örebro County
• Investigators: Principal Investigator: Piotr Kozlowski, MD, Orebro University Hospital, Orebro University

Study record dates

Study Major Dates

• Study Start: October 1, 2002
• Primary Completion (Actual): February 1, 2013

Study Registration Dates

• First Submitted: September 7, 2013
• First Submitted That Met QC Criteria: September 21, 2013
• First Posted (Estimate): September 25, 2013

Study Record Updates

• Last Update Posted (Estimate): September 25, 2013
• Last Update Submitted That Met QC Criteria: September 21, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Keywords: chemotherapy; allogeneic stem cell transplantation; T-cell Acute Lymphoblastic Leukemia
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
• Other Study ID Numbers: SVALL-02