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Therapy of Acute Myeloid Leukemia in Patients Over the Age of 60 : DA Versus Mitoxantrone With Intermittent AraC

Primary Purpose

Leukemia, Nonlymphocytic, Acute

Status

Completed

Phase

Phase 4

Locations

Germany

Study Type

Interventional

Intervention

randomization between two established Chemotherapies

About this trial

This is an interventional treatment trial for Leukemia, Nonlymphocytic, Acute focused on measuring Chemotherapy, elderly

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Diagnosis of AML age >60 no previous Chemo for AML informed consent Karnofsky >70 Exclusion Criteria: 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

Sites / Locations

Universitätsklinikum

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Daunorubicin + Ara-C

Mitoxantrone + Ara-C

Arm Description

Outcomes

Primary Outcome Measures

Complete remission rate

Survival

Secondary Outcome Measures

toxicity

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

Full Information

NCT ID

NCT00180167

First Posted

September 13, 2005

Last Updated

August 19, 2010

Sponsor

Technische Universität Dresden

1. Study Identification

Unique Protocol Identification Number

NCT00180167

Brief Title

Therapy of Acute Myeloid Leukemia in Patients Over the Age of 60 : DA Versus Mitoxantrone With Intermittent AraC

Official Title

Therapy of AML in Patients Older Than 60 Years: Randomized Comparison of a Double Induction With Daunorubicin and AraC (as Continuous Infusion) With a Double Induction With Mitoxantrone and Intermittent, Medium High Dose AraC

Study Type

Interventional

2. Study Status

Record Verification Date

August 2010

Overall Recruitment Status

Completed

Study Start Date

January 2005 (undefined)

Primary Completion Date

July 2010 (Actual)

Study Completion Date

July 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Technische Universität Dresden

4. Oversight

Data Monitoring Committee

5. Study Description

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).

Detailed Description

Randomized comparison of the two protocols.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Leukemia, Nonlymphocytic, Acute

Keywords

Chemotherapy, elderly

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

492 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Daunorubicin + Ara-C

Arm Type

Active Comparator

Arm Title

Mitoxantrone + Ara-C

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

randomization between two established Chemotherapies

Primary Outcome Measure Information:

Title

Complete remission rate

Title

Survival

Secondary Outcome Measure Information:

Title

toxicity

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ulrich S. Schuler, PD Dr. med.

Organizational Affiliation

University Hospital Dresden, Germany

Official's Role

Principal Investigator

Facility Information:

Facility Name

Universitätsklinikum

City

Dresden

State/Province

Sachsen

ZIP/Postal Code

D-1307

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

11999557

Citation

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.

Results Reference

background

PubMed Identifier

36064577

Citation

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.

Results Reference

derived

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Therapy of Acute Myeloid Leukemia in Patients Over the Age of 60 : DA Versus Mitoxantrone With Intermittent AraC

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