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

NCT ID: NCT01950286

Last Updated: 2013-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

24 participants

Study Classification

OBSERVATIONAL

Study Start Date

2002-10-31

Brief Summary

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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

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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).

Conditions

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T-cell Acute Lymphoblastic Leukemia

Keywords

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T-cell Acute Lymphoblastic Leukemia chemotherapy allogeneic stem cell transplantation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

Inclusion Criteria: all patients with T-ALL diagnosis

Exclusion Criteria: no
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Region Örebro County

OTHER

Sponsor Role lead

Responsible Party

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Piotr Kozlowski

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Piotr Kozlowski, MD

Role: PRINCIPAL_INVESTIGATOR

Orebro University Hospital, Orebro University

Locations

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Orebro University Hospital

Örebro, Örebro County, Sweden

Site Status

Countries

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Sweden

Other Identifiers

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SVALL-02

Identifier Type: -

Identifier Source: org_study_id