ID

27686

Description

Phase I/II Trial: BIBF 1120 Added to Low-dose Cytarabine in Elderly Patients With Acute Myeloid Leukemia (AML) - NCT01488344 https://clinicaltrials.gov/ct2/show/NCT01488344 Principal Investigator PD Dr. Utz Krug RATIONALE: Low-dose cytarabine works in a minority of elderly patients with an acute myeloid leukemia unfit for intensive induction therapy by killing of leukemia cells. Addition of BIBF1120 to low-dose cytarabine might enhance the killing of leukemia cells. PURPOSE: This phase I / II trial is studying how safe BIBF1120 can be combined with low-dose cytarabine (phase I) and how well the combination of low-dose cytarabine and BIBF1120 works in elderly patients with acute myeloid leukemia unfit for intensive chemotherapy (phase II). Study Type: Interventional Study Design: Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment Official Title: A Single-arm, Open Label, Multi-center Phase I/II Trial to Assess the Safety and Efficacy of BIBF 1120 Added to Low-dose Cytarabine in Elderly Patients With AML Unfit for an Intensive Induction Therapy

Link

https://clinicaltrials.gov/ct2/show/NCT01488344

Keywords

  1. 11/26/17 11/26/17 -
Copyright Holder

PD Dr. Utz Krug

Uploaded on

November 26, 2017

DOI

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License

Creative Commons BY-NC 3.0

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BIBF 1120 Added to Low-dose Cytarabine in Elderly Patients With AML NCT01488344

Follow up

  1. StudyEvent: ODM
    1. Follow up
Follow Up (regulär: bei Tod oder 1 Jahr nach Therapiebeginn)
Description

Follow Up (regulär: bei Tod oder 1 Jahr nach Therapiebeginn)

Alias
UMLS CUI-1
C1522577
Kontakt am
Description

Follow up date

Data type

date

Alias
UMLS CUI [1]
C3694716
Status
Description

Follow up status

Data type

integer

Alias
UMLS CUI [1]
C0589120
Patient ist verstorben am:
Description

Date of death

Data type

date

Alias
UMLS CUI [1]
C1148348
Unterschrift
Description

Unterschrift

Alias
UMLS CUI-1
C2346576
Datum
Description

Date of investigator signature

Data type

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
Name
Description

Investigator name

Data type

text

Alias
UMLS CUI [1]
C2826892
Unterschrift
Description

Investigator signature

Data type

text

Alias
UMLS CUI [1]
C2346576

Similar models

Follow up

  1. StudyEvent: ODM
    1. Follow up
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Follow Up (regulär: bei Tod oder 1 Jahr nach Therapiebeginn)
C1522577 (UMLS CUI-1)
Follow up date
Item
Kontakt am
date
C3694716 (UMLS CUI [1])
Item
Status
integer
C0589120 (UMLS CUI [1])
Code List
Status
CL Item
Patient lebt 1 Jahr nach Therapiebeginn (1)
CL Item
Patient ist verstorben am:  (2)
CL Item
Lost to Follow Up (3)
Date of death
Item
Patient ist verstorben am:
date
C1148348 (UMLS CUI [1])
Item Group
Unterschrift
C2346576 (UMLS CUI-1)
Date of investigator signature
Item
Datum
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Investigator name
Item
Name
text
C2826892 (UMLS CUI [1])
Investigator signature
Item
Unterschrift
text
C2346576 (UMLS CUI [1])

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