NCT01950286

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2002

Completed
10.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 7, 2013

Completed
18 days until next milestone

First Posted

Study publicly available on registry

September 25, 2013

Completed
Last Updated

September 25, 2013

Status Verified

September 1, 2013

Enrollment Period

10.3 years

First QC Date

September 7, 2013

Last Update Submit

September 21, 2013

Conditions

T-cell Acute Lymphoblastic Leukemia

Keywords

T-cell Acute Lymphoblastic Leukemiachemotherapyallogeneic stem cell transplantation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • leukemia free survival

    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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Orebro University Hospital

Örebro, Örebro County, 70185, Sweden

Location

MeSH Terms

Conditions

Precursor T-Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Precursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Piotr Kozlowski, MD

    Orebro University Hospital, Orebro University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
20 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

September 7, 2013

First Posted

September 25, 2013

Study Start

October 1, 2002

Primary Completion

February 1, 2013

Last Updated

September 25, 2013

Record last verified: 2013-09

Locations

SE(1)