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AML96 - Risk-Adapted and Randomized Postremission-Therapy for Adult Acute Myeloid Leukemia Patients

Primary Purpose

Leukemia, Nonlymphoblastic, Acute

Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Cytarabine Dosage
Sponsored by
Technische Universität Dresden
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia, Nonlymphoblastic, Acute focused on measuring acute myeloid leukemia, cytarabine postremission dosage, risk adapted treatment strategy, allogeneic stem cell transplantation, autologous stem cell transplantation

Eligibility Criteria

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

Inclusion Criteria: de novo or secondary acute myeloid leukemia of the FAB subtypes M0-M2 and M4-M7 de novo or secondary myelodysplastic syndrome FAB subtypes RAEB and RAEB-T written informed consent Exclusion Criteria: severe comorbidities severe uncontrolled complications of the leukemia previous therapy of leukemia/MDS HIV-Infection known relevant allergy against study medication pregnancy missing written informed consent

Sites / Locations

  • Medical Department I, University Hospital Carl Gustav Carus

Outcomes

Primary Outcome Measures

- rate of complete remission
- overall survival
- relapse-free survival

Secondary Outcome Measures

- frequencies and grade of treatment side effects
- deaths within induction therapy
- deaths within postremission therapy
- feasibility according to dosages and time-intervals

Full Information

First Posted
September 12, 2005
Last Updated
July 16, 2007
Sponsor
Technische Universität Dresden
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1. Study Identification

Unique Protocol Identification Number
NCT00180115
Brief Title
AML96 - Risk-Adapted and Randomized Postremission-Therapy for Adult Acute Myeloid Leukemia Patients
Official Title
AML96 - Risk-Adapted and Randomized Postremission-Therapy for Adult Acute Myeloid Leukemia Patients. A Cooperative AML-Study of the German SHG-Study Group.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2007
Overall Recruitment Status
Completed
Study Start Date
February 1996 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2008 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Technische Universität Dresden

4. Oversight

5. Study Description

Brief Summary
The AML96 study examines the feasibility of a risk-adapted postremission treatment strategy including related and unrelated allogeneic stem cell transplantation for high risk AML patients and related allogeneic and autologous stem cell transplantation for standard risk AML patients in a multi-center setting. Furthermore it randomizes patients between intermediate-dose Cytarabine vs high-dose Cytarabine within the first postremission-course.
Detailed Description
The AML96 study examines the feasibility of a risk-adapted postremission treatment strategy including related and unrelated allogeneic stem cell transplantation for high risk AML patients and related allogeneic and autologous stem cell transplantation for standard risk AML patients in a multi-center setting. Furthermore it randomizes patients between intermediate-dose Cytarabine vs high-dose Cytarabine within the first postremission-course.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Nonlymphoblastic, Acute
Keywords
acute myeloid leukemia, cytarabine postremission dosage, risk adapted treatment strategy, allogeneic stem cell transplantation, autologous stem cell transplantation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Cytarabine Dosage
Primary Outcome Measure Information:
Title
- rate of complete remission
Title
- overall survival
Title
- relapse-free survival
Secondary Outcome Measure Information:
Title
- frequencies and grade of treatment side effects
Title
- deaths within induction therapy
Title
- deaths within postremission therapy
Title
- feasibility according to dosages and time-intervals

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: de novo or secondary acute myeloid leukemia of the FAB subtypes M0-M2 and M4-M7 de novo or secondary myelodysplastic syndrome FAB subtypes RAEB and RAEB-T written informed consent Exclusion Criteria: severe comorbidities severe uncontrolled complications of the leukemia previous therapy of leukemia/MDS HIV-Infection known relevant allergy against study medication pregnancy missing written informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerhard Ehninger, MD
Organizational Affiliation
University Hospital Carl Gustav Carus Dresden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical Department I, University Hospital Carl Gustav Carus
City
Dresden
ZIP/Postal Code
01307
Country
Germany

12. IPD Sharing Statement

Citations:
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
PubMed Identifier
28945881
Citation
Heidrich K, Thiede C, Schafer-Eckart K, Schmitz N, Aulitzky WE, Kramer A, Rosler W, Hanel M, Einsele H, Baldus CD, Trappe RU, Stolzel F, Middeke JM, Rollig C, Taube F, Kramer M, Serve H, Berdel WE, Ehninger G, Bornhauser M, Schetelig J; Study Alliance Leukemia (SAL). Allogeneic hematopoietic cell transplantation in intermediate risk acute myeloid leukemia negative for FLT3-ITD, NPM1- or biallelic CEBPA mutations. Ann Oncol. 2017 Nov 1;28(11):2793-2798. doi: 10.1093/annonc/mdx500.
Results Reference
derived
PubMed Identifier
24923295
Citation
Herold T, Metzeler KH, Vosberg S, Hartmann L, Rollig C, Stolzel F, Schneider S, Hubmann M, Zellmeier E, Ksienzyk B, Jurinovic V, Pasalic Z, Kakadia PM, Dufour A, Graf A, Krebs S, Blum H, Sauerland MC, Buchner T, Berdel WE, Woermann BJ, Bornhauser M, Ehninger G, Mansmann U, Hiddemann W, Bohlander SK, Spiekermann K, Greif PA. Isolated trisomy 13 defines a homogeneous AML subgroup with high frequency of mutations in spliceosome genes and poor prognosis. Blood. 2014 Aug 21;124(8):1304-11. doi: 10.1182/blood-2013-12-540716. Epub 2014 Jun 12.
Results Reference
derived
PubMed Identifier
20442365
Citation
Rollig C, Thiede C, Gramatzki M, Aulitzky W, Bodenstein H, Bornhauser M, Platzbecker U, Stuhlmann R, Schuler U, Soucek S, Kramer M, Mohr B, Oelschlaegel U, Stolzel F, von Bonin M, Wermke M, Wandt H, Ehninger G, Schaich M; Study Alliance Leukemia. A novel prognostic model in elderly patients with acute myeloid leukemia: results of 909 patients entered into the prospective AML96 trial. Blood. 2010 Aug 12;116(6):971-8. doi: 10.1182/blood-2010-01-267302. Epub 2010 May 4.
Results Reference
derived
PubMed Identifier
18056840
Citation
Wandt H, Schakel U, Kroschinsky F, Prange-Krex G, Mohr B, Thiede C, Pascheberg U, Soucek S, Schaich M, Ehninger G. MLD according to the WHO classification in AML has no correlation with age and no independent prognostic relevance as analyzed in 1766 patients. Blood. 2008 Feb 15;111(4):1855-61. doi: 10.1182/blood-2007-08-101162. Epub 2007 Dec 4.
Results Reference
derived

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AML96 - Risk-Adapted and Randomized Postremission-Therapy for Adult Acute Myeloid Leukemia Patients

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