NCT00199095

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Feb 1997

Longer than P75 for phase_4

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 1997

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2003

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
Last Updated

March 20, 2023

Status Verified

March 1, 2023

Enrollment Period

6.3 years

First QC Date

September 12, 2005

Last Update Submit

March 16, 2023

Conditions

Adult Acute Lymphocytic Leukemia

Keywords

ALLElderlyChemotherapy

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

AdriamycinDRUG
CyclophosphamideDRUG
CytarabineDRUG
DexamethasoneDRUG
IdarubicinDRUG
IfosfamideDRUG
MethotrexateDRUG
MercaptopurineDRUG
VM26DRUG
VincristineDRUG

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital, Medical Dept. II

Frankfurt, 60590, Germany

Location

Related Links

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

DoxorubicinCyclophosphamideCytarabineDexamethasoneIdarubicinIfosfamideMethotrexateMercaptopurineTeniposideVincristine

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

DaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydratesPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedPhosphoramidesOrganophosphorus CompoundsCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsArabinonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsSteroids, FluorinatedOxazinesAminopterinPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingSulfhydryl CompoundsSulfur CompoundsPurinesGlucosidesVinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsIndolesIndolizidinesIndolizines

Study Officials

  • Dieter Hoelzer, MD

    University Hospital Frankfurt, Medical Dept. II

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of GMALL

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

February 1, 1997

Primary Completion

June 1, 2003

Study Completion

June 1, 2003

Last Updated

March 20, 2023

Record last verified: 2023-03

Locations

DE(1)