Treatment of Elderly Patients (>65 Years) With Acute Lymp... | NCT00199095

Studies
Treatment of Elderly Patients (>65 Years) With Acute Lymphoblastic Leukemia

NCT00199095

Sponsor

Goethe University

Status

Completed

Last Update Posted

Mar 20, 2023Actual

Enrollment

Phase

Phase 4

Conditions

Adult Acute Lymphocytic Leukemia

Interventions

Adriamycin
Cyclophosphamide
Cytarabine
Dexamethasone
Idarubicin
Ifosfamide
Methotrexate
Mercaptopurine
VM26
Vincristine

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1997Actual

Primary Completion Date

Jun 2003Actual

Completion Date

Jun 2003Actual

First Submitted Date

Sep 12, 2005

First Submission Date that Met QC Criteria

Sep 12, 2005

First Posted Date

Sep 20, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 16, 2023

Last Update Posted Date

Mar 20, 2023Actual

Description Module

Brief Summary

The aim of this study is to test feasibility and efficacy of a dose reduced chemotherapy in elderly patients with newly diagnosed acute lymphoblastic leukemia. The regimen consists of induction phase I and II followed by cyclic consolidation cycles, reinduction and maintenance therapy

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Adriamycin	Drug
Cyclophosphamide	Drug
Cytarabine	Drug
Dexamethasone	Drug
Idarubicin	Drug
Ifosfamide	Drug
Methotrexate	Drug
Mercaptopurine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Results of induction therapy,Distribution of entry criteria,Treatment feasibility,Relapse rate and localisation,Death in CR,Remission duration, survival and leukemia free survival,Prognostic factors,Quality of life

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

diagnosis of acute lymphoblastic leukemia (pro-B,common,pre-B,pre-T,Thy-,mature T, B-ALL)
age > 65 years
written informed consent
Karnofsky > 50% (if not mainly caused by leukemia)
laboratory at diagnosis or after supportive pre-treatment Creatinine < 2 mg/dl Uric Acid < 8 mg/dl Bilirubin < 1.5 mg/dl ALA, ASA,AP < 2.5 x ULN

Exclusion Criteria:

severe second diseases (e.g. renal failure, cardiomyopathy etc., not caused by leukemia) that exclude treatment according to the protocol
severe psychiatric illness or other circumstances which may compromise cooperation
active second neoplasia
clinical signs of life threatening infections or bleeding, uncontrollable prior to chemotherapy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dieter Hoelzer, MD	University Hospital Frankfurt, Medical Dept. II	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital, Medical Dept. II		Frankfurt		60590	Germany

Label	URL
German Leukemia Trial Registry	View source

Condition Browse Module

MeSH Terms

ID	Term
D054198	Precursor Cell Lymphoblastic Leukemia-Lymphoma

Ancestor Terms

ID	Term
D007945	Leukemia, Lymphoid
D007938	Leukemia
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D004317	Doxorubicin
D003520	Cyclophosphamide
D003561	Cytarabine
D003907	Dexamethasone
D015255	Idarubicin
D007069	Ifosfamide
D008727	Methotrexate
D015122	Mercaptopurine
D013713	Teniposide
D014750	Vincristine

Ancestor Terms

ID	Term
D003630	Daunorubicin
D018943	Anthracyclines
D009279	Naphthacenes
D011084	Polycyclic Aromatic Hydrocarbons

Browse Leaves

Not provided

Browse Branches

Not provided