Treatment Outcome in Elderly Patients
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00700544 |
Recruitment Status :
Completed
First Posted : June 18, 2008
Last Update Posted : June 18, 2008
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
AML Elderly Patients | Drug: chemotherapy treatment (see arm) + norethandrolone Drug: chemotherapy treatment (see arms) | Phase 3 |
-
Induction Therapy:
- Idarubicin, 8mg/m2 d1-5; Cytarabine, 100mg/m2 d1-7 and Lomustine, 200mg/m d1
- if CR or PR: randomisation = maintenance therapy including or not androgens
-
Maintenance therapy :
- 6 courses of reinduction with idarubicin (8mg/m2 d1) and cytarabine (100mg/m2d1-5, subcutaneously) every 3 months, and, between these courses, a continuous regimen of methotrexate and 6-mercaptopurine.
- Patients randomized with androgens additionally received 10 to 20 mg according to body weigh of norethandrolone daily for up to 2 years
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 330 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Adjonction of Androgenotheapy for Post-Remission Treatment of Elderly Patients With Acute Myeloid Leukemia - Results of the Multicenter Goelams SA-2002 Trial. |
Study Start Date : | June 2002 |
Actual Primary Completion Date : | April 2005 |
Actual Study Completion Date : | May 2008 |
Arm | Intervention/treatment |
---|---|
Active Comparator: B
|
Drug: chemotherapy treatment (see arms)
Induction chemotherapy + maintenance chemotherapy
Other Name: Induction chemotherapy + maintenance chemotherapy |
Experimental: A
|
Drug: chemotherapy treatment (see arm) + norethandrolone
oral form Dosage: 10 mg in patients with a weight < 60 kgs 20 mg in patients with a weight > 60 kgs frequency: every day Duration: 2 years Other Name: norethandrolone = nilevar® |
- The primary objective of this study was to assess the ability of androgens to increase DFS. [ Time Frame: 3 years ]
- The secondary objective was to improved EFS and OS and to assess side effects and toxicity of androgenotherapy [ Time Frame: 3 years ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 60 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients aged 60 years or more
- "de novo" AML according to FAB criteria
- AML with 20% or more myeloid marrow blasts
- signed and dated informed consent
- OMS score < 3
- Life expectancy > 1 month
Exclusion Criteria:
- Patients aged < 60 years
- or AML M3
- or not classificated according to FAB criteria
- or extramedular localisation of AML
- OMS score ≥ 3
- clinical Abnormal Cardiac fonction or with left ejection fraction < 40 %
- abnormal renal function with creatinine clearance < 50/ml/mn/m²
- abnormal hepatic function
- previous cerebral stroke
- previous malignancy : prostate, breast cancer (males)
- PSA dosage > 4
- Any coexisting medical or psychological condition that would pleclude participation in the required study procedures
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00700544
France | |
Arnaud PIGNEUX | |
Pessac, France, 33604 |
Principal Investigator: | Jean jacques SOTTO, MD | GOELAMS/BGMT | |
Principal Investigator: | Arnaud PIGNEUX, MS | GOELAMS/BGMT | |
Principal Investigator: | Francis WITZ, MS | French Innovative Leukemia Organisation |
Responsible Party: | CHU Grenoble Pr Jean Jacques SOTTO, GOELAMS BGMT |
ClinicalTrials.gov Identifier: | NCT00700544 |
Other Study ID Numbers: |
LAM SA 2002 |
First Posted: | June 18, 2008 Key Record Dates |
Last Update Posted: | June 18, 2008 |
Last Verified: | June 2008 |
AML elderly patients Treatment outcome |
Norethandrolone Anabolic Agents Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |