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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

T-cell Acute Lymphoblastic Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma Precursor T-Cell Lymphoblastic Leukemia-Lymphoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Orebro University Hospital

Örebro, Örebro County, 70185, Sweden

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

all patients with T-ALL diagnosis

Exclusion criteria

Treatment and study plan

Primary outcomes

overall survival

Time frame: 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 outcomes

leukemia free survival

Time frame: 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

Sponsors and collaborators

Lead sponsor

Region Örebro County

Other

Registry information

Official study title

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

Important dates

Study start: 2002
Primary completion: 2013
First posted: Sep 25, 2013
Registry last updated: Sep 25, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed