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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01950286
Recruitment Status : Completed
First Posted : September 25, 2013
Last Update Posted : September 25, 2013
Sponsor:
Information provided by (Responsible Party):
Piotr Kozlowski, 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.

Condition or disease
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).

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Study Type : Observational [Patient Registry]
Actual Enrollment : 24 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 20 Years
Official Title: Four Years Experience With Hyper-CVAD Treatment of Adult T-cell Acute Lymphoblastic Leukemia in Sweden. Population-based Data.
Study Start Date : October 2002
Actual Primary Completion Date : February 2013





Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

Inclusion Criteria: all patients with T-ALL diagnosis

Exclusion Criteria: no


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01950286


Locations
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Sweden
Orebro University Hospital
Orebro, Orebro county, Sweden, 70185
Sponsors and Collaborators
Region Örebro County
Investigators
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Principal Investigator: Piotr Kozlowski, MD Orebro University Hospital, Orebro University

Additional Information:

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Responsible Party: Piotr Kozlowski, MD, Region Örebro County
ClinicalTrials.gov Identifier: NCT01950286    
Other Study ID Numbers: SVALL-02
First Posted: September 25, 2013    Key Record Dates
Last Update Posted: September 25, 2013
Last Verified: September 2013
Keywords provided by Piotr Kozlowski, Region Örebro County:
T-cell Acute Lymphoblastic Leukemia
chemotherapy
allogeneic stem cell transplantation
Additional relevant MeSH terms:
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Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases