Phase 3 Trial for AML Patients in CR2 Comparing 8Gy TBI /... | NCT00125606

Studies
Phase 3 Trial for AML Patients in CR2 Comparing 8Gy TBI /Fludarabine to Conditioning With TBI 12Gy/Cyclophosphamide

NCT00125606

Sponsor

University Hospital Muenster

Status

Terminated

Last Update Posted

Dec 18, 2012Estimated

Enrollment

30Actual

Phase

Phase 3

Conditions

Acute Myeloid Leukemia

Interventions

conditioning for allogeneic HSCT

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

Dec 2012

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

insufficient patient recruitement

Expanded Access Info

Start Date

Oct 2004

Primary Completion Date

Jul 2011Actual

Completion Date

Jul 2011Actual

First Submitted Date

Jul 26, 2005

First Submission Date that Met QC Criteria

Jul 29, 2005

First Posted Date

Aug 1, 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

Dec 17, 2012

Last Update Posted Date

Dec 18, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sponsor

Lead Sponsor

University Hospital MuensterOTHER

Collaborators

Name	Class
Technische Universität Dresden	OTHER
Philipps University Marburg	OTHER
Universitätsklinikum Hamburg-Eppendorf	OTHER
Hannover Medical School

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

For patients with acute myeloid leukemia (AML), allogeneic hematopoetic stem cell transplantation (HSCT) is one of the most potent treatment options currently available. In order to overcome the high risk of fatal treatment-related complications, reduced intensity and nonmyeloablative conditioning regimens for allogeneic HSCT are currently being explored in various hematological malignancies including AML. At least for allogeneic HSCT in AML, the optimal dose-intensity of preparative regimens for disease control at an acceptable rate of treatment-related lethal complications has not been determined. The investigators, therefore, evaluated reduced intensity myeloablative conditioning with 8 Gy TBI and fludarabine in AML patients considered ineligible for conventional conditioning in a phase 2 trial (data published in BLOOD by Stelljes et al., 2005). The results suggest that with 8 Gy TBI/fludarabine, conditioning related and unrelated donor transplants can be performed in AML patients in first or second complete remission (CR) with a remarkably low 2-year non relapse mortality (NRM) and satisfactory disease control. Based on these data a randomized phase 3 trial for patients with AML in CR≥2 is currently being conducted by the Cooperative German Transplant Study Group comparing TBI 8 Gy/fludarabine to conventionally dosed conditioning with TBI 12 Gy/cyclophosphamide.

Detailed Description

Not provided

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

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
conditioning therapy with 12 Gy TBI / cyclophosphamide 120	Active Comparator		Procedure: conditioning for allogeneic HSCT
conditioning therapy with 8 Gy TBI / fludarabine 120	Experimental		Procedure: conditioning for allogeneic HSCT

Interventions

Name	Type	Description	Arm Group Labels	Other Names
conditioning for allogeneic HSCT	Procedure		conditioning therapy with 12 Gy TBI / cyclophosphamide 120 conditioning therapy with 8 Gy TBI / fludarabine 120

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
treatment related mortality

Secondary Outcomes

Measure	Description	Time Frame
event free survival
overall survival
cumulative incidence of acute and chronic graft-versus-host disease (GvHD)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with AML in second complete remission
HLA-identical related (HLA * A, B, and DR) or HLA-compatible unrelated donor with maximum of one Ag mismatch
Ages 18-60 years
Written informed consent from the patient
Written informed consent from the donor
No major organ dysfunction

Exclusion Criteria:

Cardiac failure (New York Heart Association [NYHA] grade II-IV)
Renal failure (creatinine > 2.0 mg/dl)
Hepatic failure (total bilirubin > 3 mg/dl)
Severe neurological/psychiatric disorder
Previous allogeneic HSCT
Contra-indications for used drugs
HIV infection
Non-compliance to processing of personal data according to the protocol

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
Matthias Stelljes, M.D.	Department of Medicine/Hematology and Oncology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Medicine/Hematology and Oncology		Münster	North Rhine-Westphalia	48149	Germany

Condition Browse Module

MeSH Terms

ID	Term
D015470	Leukemia, Myeloid, Acute

Ancestor Terms

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

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Browse Branches

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