Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00589082
Other study ID # GSI 103-AMLE
Secondary ID
Status Completed
Phase Phase 3
First received December 24, 2007
Last updated January 8, 2008
Start date October 2001
Est. completion date November 2005

Study information

Verified date December 2007
Source Gruppo Italiano Malattie EMatologiche dell'Adulto
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Overall results in the treatment of middle aged adults acute myelogenous leukemia (AML) are substantially improved in the last decade, with complete remission (CR) rates established to values of 70 to 80per cent and also encouraging long-term outcome, especially in patients who can tolerate intensified post remissional treatment strategies. On the contrary, there has been little progress in the treatment of older patients. In these patients the response rate generally range between 40 and 60per cent, and overall survival at 2 years is often less than 10 per cent.

Usually, a combination of anthracyclines daunomycin DNR or doxorubicin and cytarabyne Ara-C has been utilized for the remission-induction treatment, with schedules similar to those utilized in younger cases, for patients eligible to intensive treatments. Variation of the dose of DNR has not brought any significant benefit. The EORTC HOVON randomized trial AML9 compared two drugs in induction for previously untreated patients. DNR versus Mithoxantrone (MTZ). MTZ induction therapy produces a slightly better CR rate than DNR-containing regimen (47per cent vs 38per cent, P equals 0.069), without any significant effect on remission duration and survival. The DFS probability between the two treatment arms was not different. The median DFS estimates were 39 weeks in both groups. The DFS rate at 5 years was 8per cent. Also the duration of survival was similar (p equals 0.23) in the two treatment groups. Median survival estimates were 36 weeks (DNR) and 39 weeks (MTZ). The percentage of patients still alive at 5 years were 6per cent and 9per cent respectively.


Description:

It can be stated that single agent DaunoXome seems associated with a level of anti-leukemic activity at least equivalent to the conventional drugs available. In addition, the safety profile of DaunoXome either as a single agent either as a combination with Ara-C seems improved with respect to the conventionally administered anthracyclines. Therefore, it seems warranted to further explore the anti-leukemic activity, the toxicity and the long term results of DaunoXome as a treatment for AML in association with Ara-C against the parent compound daunorubicin. In particular, we propose a study to evaluate standard 3+7 schedule versus the same schedule with DaunoXome instead of daunorubicine as front line treatment in AML patients older than 60 years. Patients achieving a CR will receive a consolidation cycle with the same drugs at the same doses. After consolidation, patients in CR will be randomized to receive a maintenance treatment with low-dose Ara-C plus Atra versus no treatment.


Recruitment information / eligibility

Status Completed
Enrollment 0
Est. completion date November 2005
Est. primary completion date November 2005
Accepts healthy volunteers No
Gender All
Age group 61 Years to 75 Years
Eligibility Inclusion Criteria:

- Previously untreated AML (including AML after MDS) with > 20% marrow blasts (new WHO classification)

- Age = 61 <75 years

- AML evoluted after MDS are eligible if not previously treated with antiblastic drugs.

- Performance status = 70 (Karnofsky) or = 2 (WHO)

- Signed informed consent from the patient

Exclusion Criteria:

Version 3.0 - february 2001 - CONFIDENTIAL 9

- Patients already treated for their AML with other cytotoxic drugs (except no more than 7 days of Corticosteroids)

- Acute promyelocitic leukemia (FAB M3 or M3v)

- Blast crisis of chronic myeloid leukemia or leukemia supervening after other

- myeloproliferative disease

- Concomitant progressive malignant disease

- Presence of meningeal disease

- History of recent myocardial infarction (within previous 12 months), significant congestive heart failure, life threatening arrhythmia, or cardiovascular disease of Class II or greater according to the New York Heart Association Functional Classification (NYHAFC).

- Abnormal cardiac ejection fraction (45% or less).

- Abnormal hepatic function (ALAT/ASAT or bilirubin >3 N ).

- Abnormal renal function (creatinine >3 N)

- Active bacterial, fungal or viral infection as documented by positive cultures, radiological imaging, clinical signs, septic fever or septic shock symptoms.

- Patients who recover from the infection could be eligible.

- History of hypersensitivity to one of the liposomal constituents.

- Severe pulmonary, neurological or psychiatric disease.

- People unable to give informed consent.

- Presence of any phychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow up schedule.

- HIV positivity

- Intercurrent organ damage or medical problems that would interfere with therapy.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
DaunoXome

Daunorubicine


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Gruppo Italiano Malattie EMatologiche dell'Adulto

References & Publications (1)

Zittoun RA, Mandelli F, Willemze R, de Witte T, Labar B, Resegotti L, Leoni F, Damasio E, Visani G, Papa G, et al. Autologous or allogeneic bone marrow transplantation compared with intensive chemotherapy in acute myelogenous leukemia. European Organization for Research and Treatment of Cancer (EORTC) and the Gruppo Italiano Malattie Ematologiche Maligne dell'Adulto (GIMEMA) Leukemia Cooperative Groups. N Engl J Med. 1995 Jan 26;332(4):217-23. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Efficacy and safety of DaunoXome in association with cytosine arabinoside in terms of reduction of induction deaths respect to standard "3+7" chemotherapy
Secondary Efficacy, in terms of DFS, of maintenance therapy with low-dose of Ara-C plus ATRA versus no maintenance therapy
See also
  Status Clinical Trial Phase
Not yet recruiting NCT05531396 - Agility Training on Physical Performance, Cognitive Function and Brain Activities in Elderly N/A
Completed NCT03580447 - The Effect of Citrus Extract on Oxidative Stress N/A
Recruiting NCT04096547 - Rivaroxaban in Elderly NVAF Patients With or Without Renal Impairment
Completed NCT03339791 - Sleeve Versus Bypass in Older Patients: a Randomized Controlled Trial N/A
Completed NCT03566719 - Effect of an Exercise Program on Risk of Fall in a Community Dwelling Older Adults N/A
Completed NCT02138968 - Clinical and Economic Assessment of a Pre-frail Screening Program N/A
Completed NCT01368029 - Safety of Lactobacillus Rhamnosus GG Vs. Placebo in Elderly Subjects Receiving Trivalent Inactivated Influenza Vaccine Phase 1
Not yet recruiting NCT01182961 - The Use of Virtual Reality for the Gait Training of Elderly Fallers N/A
Completed NCT01899586 - Mechanisms and Functional Outcomes of Exercise Progression Models in the Elderly N/A
Completed NCT00961012 - The Big Squeeze (Lessening the Big Squeeze: The Effect of the Trunk Release on Interface Pressures of Individuals Seated in a High Fowler's Positions) N/A
Completed NCT00748683 - Development of an Integrated Health Care Environment for Elderly With RFID Technology Phase 0
Completed NCT00533065 - Effects of Donepezil on Deficits Associated With Age-Related Decrease of Growth Hormone N/A
Completed NCT00324701 - Telepsychology-Service Delivery for Depressed Elderly Veterans N/A
Completed NCT00798668 - The Body's Response to Food Intake in Trained, Older Adults N/A
Completed NCT00217113 - An Intervention to Preserve Functional Status and Independence Among Community Dwelling Elderly N/A
Completed NCT03666793 - Comprehensive Management of Drug Prescriptions Throughout the Elderly Person's Hospital Care N/A
Recruiting NCT06030804 - Perioperative Dexmedetomidine and Long-term Survival After Cancer Surgery N/A
Recruiting NCT05014750 - Frailty of Elderly With Valvular Heart Disease and the Short Term Adverse Events
Completed NCT05021432 - Virtual Reality And Task Oriented Circuit Training Among Elderly Population N/A
Active, not recruiting NCT04132492 - AGNES - Aging Nephropathy Study, a Prospective Observational Cohort of Chronic Kidney Disease in Elderly Patients