Clinical trial NCT01950286: Hyper-CVAD Treatment of Adult T-cell Acute Lymphoblastic Leukemia in Sweden.
Official title: Four Years Experience With Hyper-CVAD Treatment of Adult T-cell Acute Lymphoblastic Leukemia in Sweden. Population-based Data.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: T-cell Acute Lymphoblastic Leukemia
Keywords: T-cell Acute Lymphoblastic Leukemia
chemotherapy
allogeneic stem cell transplantation
Lead sponsor: Region Örebro County
Sponsor class: OTHER
First posted: 2013-09-25
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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).

Eligibility criteria: Inclusion Criteria: all patients with T-ALL diagnosis

Exclusion Criteria: no

Primary outcomes:
measure: overall survival
timeFrame: 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 outcomes:
measure: leukemia free survival
timeFrame: 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.
Other outcomes:
Locations:
city: Orebro
country: Sweden
facility: Orebro University Hospital
state: Orebro county
Study officials:
affiliation: Orebro University Hospital, Orebro University
name: Piotr Kozlowski, MD
role: PRINCIPAL_INVESTIGATOR
References: