Standard vs. Reduced-Intensity Conditioning in Patients W... | NCT00150878

Studies
Standard vs. Reduced-Intensity Conditioning in Patients With Acute Myeloid Leukemia in First Remission

NCT00150878

Sponsor

University Hospital Carl Gustav Carus

Status

Terminated

Last Update Posted

Jun 20, 2013Estimated

Enrollment

198Actual

Phase

Phase 3

Conditions

Acute Myeloid Leukemia

Interventions

Conditioning therapy

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2013

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Insurance coverage reached

Expanded Access Info

Start Date

Dec 2003

Primary Completion Date

Dec 2009Actual

Completion Date

Dec 2010Actual

First Submitted Date

Sep 6, 2005

First Submission Date that Met QC Criteria

Sep 6, 2005

First Posted Date

Sep 8, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 19, 2013

Last Update Posted Date

Jun 20, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

University Hospital Carl Gustav CarusOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The primary goal of the study is to show that the treatment-related mortality of allogeneic hematopoietic stem cell transplantation an be significantly reduced by using a combination of 8 Gy total-body-irradiation and fludarabine in comparison to the conventional combination of 12 Gy TBI and 120 mg/kg Cyclophosphamide.

Detailed Description

Transplant-related deaths because of extramedullary toxicity and graft-versus host disease remain the major causes for treatment-failure in patients with AMl receiving allogeneic hematopoietic stem cell transplantation.

In phase II study, M . Stelljes and coworkers could show, that a reduced dose of total-body- irradiation and fludarabine can be safely used in patients with AML at various disease stages. The best results could be achieved in patients who had been in complete remission by the time of inclusion.

Therefore this prospective trial was initiated to compare the new conditioning regimen with the standard regimen of 12 Gy TBI/Cyclophosphamide 120 mg/kg in patients ith AML in first remission.

After having achieved complete remission, and giving informed consent, patients are stratified according to marrow cytogenetics, age and type of induction therapy and subsequently randomized to receive on of the mentioned conditioning therapies.

The primary end-point will be non-relapse mortality. The hypothesis would be, that the one-year mortality can be reduced from 25 to 15%. Given a power of 0.8 and a first-error of 5%, 252 patients will have to be randomized.

Secondary endpoints include:

3 year overall-and disease-free survival Rate of grade II-IV acute GvHD Rate of grade 3-4 extramedullary toxicity

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

198Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
12 Gy/Cyclophosphamide	Other	Standard intensity conditioning	Other: Conditioning therapy
8 Gy /Fludarabine	Experimental	Reduced-intensity conditioning	Other: Conditioning therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Conditioning therapy	Other	Preparation before allogeneic transplantation	12 Gy/Cyclophosphamide 8 Gy /Fludarabine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Treatment-related mortality at 12 months after transplantation	Proportion of patients dying without prior relapse	12 months

Secondary Outcomes

Measure	Description	Time Frame
Disease-free and Overall survival	Proportion of patients alive without relapse	5 years
Grade 3-4 extramedullary toxicity	Percentage of patients with grade II-IV acute GvHD

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of acute myeloid leukemia in first remission
Standard-or high-risk marrow cytogenetics
HLA-matched related or unrelated donor available (in case of high-risk disease)
Age 18 to 60
Informed consent
Consent of donor to donate peripheral blood stem cells
sufficient liver function (elevation of transferases < 2.5 x upper limit)

Exclusion Criteria:

AML with t(5;17)
AML with t((8;21)
clinically relevant heart failure (NYHA II-IV)
Renal failure (creatinine > 200 µg/ml)
Liver function failure (bilirubin > 3 mg/dl)
Concomitant Neurological or psychiatric disease
Contraindications to receive prescribed study medication
HIV infection
Pregnancy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gerhard Ehninger, MD	Director of Med. Klink und Poliklinik I, Technical University Dresden	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medizinische Klinik und Poliklinik I		Dresden		01307	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
16020510	Background	Stelljes M, Bornhauser M, Kroger M, Beyer J, Sauerland MC, Heinecke A, Berning B, Scheffold C, Silling G, Buchner T, Neubauer A, Fauser AA, Ehninger G, Berdel WE, Kienast J; Cooperative German Transplant Study Group. Conditioning with 8-Gy total body irradiation and fludarabine for allogeneic hematopoietic stem cell transplantation in acute myeloid leukemia. Blood. 2005 Nov 1;106(9):3314-21. doi: 10.1182/blood-2005-04-1377. Epub 2005 Jul 14.
29550384

ID	Term
D007951	Leukemia, Myeloid
D007938	Leukemia
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

ID	Term
D011613	Psychotherapy
D004191	Behavioral Disciplines and Activities