NCT00180167

Brief Summary

Single Arm-Studies suggest improved remission and survival rates for a Protocol with Mitoxantron 10mg/m2 for 3 days combined with AraC 1g/m2 bid on days 1+3+5+7 compared to a conventional DA 7+3 protocol (45mg/m2 Daunorubicin).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
492

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2005

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

January 1, 2005

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

August 20, 2010

Status Verified

August 1, 2010

Enrollment Period

5.5 years

First QC Date

September 13, 2005

Last Update Submit

August 19, 2010

Conditions

Leukemia, Nonlymphocytic, Acute

Keywords

Chemotherapyelderly

Outcome Measures

Primary Outcomes (2)

  • Complete remission rate

  • Survival

Secondary Outcomes (2)

  • toxicity

  • Secondary purpose: Is the prognostic evaluation of the treating physician prior to initiation of chemotherapy (prior to randomization) of predictive value?

Study Arms (2)

Daunorubicin + Ara-C

ACTIVE COMPARATOR
Drug: randomization between two established Chemotherapies

Mitoxantrone + Ara-C

EXPERIMENTAL
Drug: randomization between two established Chemotherapies

Interventions

randomization between two established ChemotherapiesDRUG
Daunorubicin + Ara-CMitoxantrone + Ara-C

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of AML
  • age \>60
  • no previous Chemo for AML
  • informed consent
  • Karnofsky \>70

You may not qualify if:

  • AML M3
  • uncontrolled Sepsis
  • uncontrolled HYpertension
  • respiratory failure
  • heart-failure NYHA IV, recent myocardial infarction
  • severe organ dysfunction of liver, kidneys,
  • HIV -infection or active Hepatitis B,C

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitätsklinikum

Dresden, Saxony, D-1307, Germany

Location

Related Publications (2)

  • Mantovani L, Hasenclever D, Krahl R, Ponisch W, Herold M, Pasold R, Fiedler F, Dolken G, Kampfe D, Schmoll HJ, Subert R, Kubel M, Niederwieser D, Helbig W; East German Hematology and Oncology Group (OSHO). Intermediate-dose cytarabine treatment delivered at moderate infusion rates for de novo acute myeloid leukemia-results of a phase I-II study. Leuk Lymphoma. 2002 Feb;43(2):265-74. doi: 10.1080/10428190290006035.

    PMID: 11999557BACKGROUND

  • Kunadt D, Stasik S, Metzeler KH, Rollig C, Schliemann C, Greif PA, Spiekermann K, Rothenberg-Thurley M, Krug U, Braess J, Kramer A, Hochhaus A, Scholl S, Hilgendorf I, Brummendorf TH, Jost E, Steffen B, Bug G, Einsele H, Gorlich D, Sauerland C, Schafer-Eckart K, Krause SW, Hanel M, Hanoun M, Kaufmann M, Wormann B, Kramer M, Sockel K, Egger-Heidrich K, Herold T, Ehninger G, Burchert A, Platzbecker U, Berdel WE, Muller-Tidow C, Hiddemann W, Serve H, Stelljes M, Baldus CD, Neubauer A, Schetelig J, Thiede C, Bornhauser M, Middeke JM, Stolzel F; A. M. L. Cooperative Group (AMLCG), Study Alliance Leukemia (SAL). Impact of IDH1 and IDH2 mutational subgroups in AML patients after allogeneic stem cell transplantation. J Hematol Oncol. 2022 Sep 5;15(1):126. doi: 10.1186/s13045-022-01339-8.

    PMID: 36064577DERIVED

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Ulrich S. Schuler, PD Dr. med.

    University Hospital Dresden, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 16, 2005

Study Start

January 1, 2005

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

August 20, 2010

Record last verified: 2010-08

Locations

DE(1)