Cladribine, Cytarabine and Idarubicin in Patients With Relapsed Acute Myelocytic Leukemia (AML)

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Primary Purpose

Status

Unknown status

Phase

Phase 2

Locations

Germany

Study Type

Interventional

Intervention

cladribine

About this trial

This is an interventional treatment trial for Leukemia, Myelocytic, Acute focused on measuring AML, relapsed, cladribine, chemotherapy

Eligibility Criteria

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

Inclusion Criteria: Patients with relapsed AML with a remission duration of at least 6 months after first complete remission (CR) or of at least 3 months after second (or higher) CR Age >= 18 years Life expectancy of at least three months (without consideration of AML and complications) Eastern Cooperative Oncology Group (ECOG) 0-2 (without consideration of AML and complications) Written informed consent Exclusion Criteria: Prior therapy of AML with cladribine Severe, uncontrolled infection at time of inclusion (enrollment is possible after control of infection) Cardiac insufficiency grade III or IV New York Heart Association (NYHA) Severe renal insufficiency with a clearance of < 30 ml/min (if not due to AML) Severe hepatic insufficiency with bilirubin > 3 mg/dl or AST > 200 U/l (if not due to AML) Other severe organ impairment grade III or IV World Health Organization (WHO) (if not due to AML or, in the opinion of the investigator, may not interfere with the procedures in the study) HIV infection Intolerance to study drugs Pregnant or breast-feeding women Any other malignant disease which will probably affect the course of AML

Sites / Locations

Medical Clinic & Policlinic III, University BonnRecruiting

Outcomes

Primary Outcome Measures

Toxicity according to National Cancer Institute/Common Toxicity Criteria (NCI/CTC), especially the rate of severe infections and the death rate

Rate of complete remission

Secondary Outcome Measures

Remission duration

Overall survival

Influence of cytogenetic aberrations on remission rate, duration of remission and overall survival

Course of CD3/CD4+ subpopulation after therapy

Full Information

NCT ID

NCT00126321

First Posted

August 2, 2005

Last Updated

February 1, 2010

Sponsor

University Hospital, Bonn

1. Study Identification

Unique Protocol Identification Number

NCT00126321

Brief Title

Cladribine, Cytarabine and Idarubicin in Patients With Relapsed Acute Myelocytic Leukemia (AML)

Official Title

Phase II Study of Cladribine, High-dose Cytarabine and Idarubicin in Patients With Relapsed Acute Myeloid Leukemia

Study Type

Interventional

2. Study Status

Record Verification Date

February 2010

Overall Recruitment Status

Unknown status

Study Start Date

November 2004 (undefined)

Primary Completion Date

November 2010 (Anticipated)

Study Completion Date

March 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

University Hospital, Bonn

4. Oversight

Data Monitoring Committee

No

5. Study Description

Brief Summary

The purpose of this study is to evaluate the safety and the efficacy of cladribine, high-dose cytarabine and idarubicin in the treatment of patients with relapsed acute myeloid leukemia.

Detailed Description

Considerable progress has been made in the induction therapy of acute myeloid leukemia (AML); however, current therapeutic results are still unsatisfactory in those with relapsed disease. The purine nucleoside analogue cladribine (2-chlorodeoxyadenosine, 2-CdA) has been shown to be a safe and active agent in acute myeloid leukemia. Synergistic interaction between cladribine and cytarabine has been demonstrated in preclinical and clinical studies. The current multicenter phase II study was initiated to evaluate the efficacy and toxicity of cladribine, high-dose cytarabine, and idarubicin in the treatment of patients with relapsed AML. Adult patients of all age groups can be enrolled in the trial, but elderly patients will be treated with a less dose-intensive regimen.

6. Conditions and Keywords

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

Leukemia, Myelocytic, Acute

Keywords

AML, relapsed, cladribine, chemotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

cladribine

Intervention Description

2-chlorodeoxyadenosine, 2-CdA

Primary Outcome Measure Information:

Title

Toxicity according to National Cancer Institute/Common Toxicity Criteria (NCI/CTC), especially the rate of severe infections and the death rate

Time Frame

continuous

Title

Rate of complete remission

Secondary Outcome Measure Information:

Title

Remission duration

Title

Overall survival

Title

Influence of cytogenetic aberrations on remission rate, duration of remission and overall survival

Title

Course of CD3/CD4+ subpopulation after therapy

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: Patients with relapsed AML with a remission duration of at least 6 months after first complete remission (CR) or of at least 3 months after second (or higher) CR Age >= 18 years Life expectancy of at least three months (without consideration of AML and complications) Eastern Cooperative Oncology Group (ECOG) 0-2 (without consideration of AML and complications) Written informed consent Exclusion Criteria: Prior therapy of AML with cladribine Severe, uncontrolled infection at time of inclusion (enrollment is possible after control of infection) Cardiac insufficiency grade III or IV New York Heart Association (NYHA) Severe renal insufficiency with a clearance of < 30 ml/min (if not due to AML) Severe hepatic insufficiency with bilirubin > 3 mg/dl or AST > 200 U/l (if not due to AML) Other severe organ impairment grade III or IV World Health Organization (WHO) (if not due to AML or, in the opinion of the investigator, may not interfere with the procedures in the study) HIV infection Intolerance to study drugs Pregnant or breast-feeding women Any other malignant disease which will probably affect the course of AML

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Axel Glasmacher, MD

Phone

+49-228-287-15507

Email

glasmacher@uni-bonn.de

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Marie von Lilienfeld-Toal, MD

Organizational Affiliation

Medical Clinic & Policlinic III, University Hospital Bonn

Official's Role

Principal Investigator

Facility Information:

Facility Name

Medical Clinic & Policlinic III, University Bonn

City

Bonn

ZIP/Postal Code

53105

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Marie von Lilienfeld-Toal, MD

Phone

+49-228-287-22263

Email

m.lilienfeld.toal@uni-bonn.de

First Name & Middle Initial & Last Name & Degree

Marie von Lilienfeld-Toal, MD

Leukemia, Myelocytic, Acute

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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