Induction With or Without Granulocyte Colony-Stimulating Factor in AML Transplantation in AML (TLG-AML-95-002)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
Background The effects of granulocyte colony-stimulating factors (G-CSF) on recovery following induction chemotherapy are widely accepted. However, their impact on response and survival has not been clarified yet. Male gender has been claimed to be a susceptibility factor for development of leukemia and shorten survival but effect of sex has not been analyzed in clinical trials utilizing G-CSF.
Design and Methods Efficacy and safety of G-CSF as an adjunct to de novo AML remission induction therapy was assessed in this prospective randomized Phase III multicenter trial. Patients were randomized to receive induction therapy consisting of either cytosine arabinoside 100mg/m2/d, days 1-10 and idarubicin 12 mg/m2/d, days 1-3 (control arm) or plus G-CSF (Filgrastim, 5 µg/kg/d starting from day 8 until absolute neutrophil count (ANC) over 0.5x109/L for two consecutive days) for a median duration of 14 days (G-CSF arm).
After achievement of CR, all patients received first consolidation course of Ara-C 1 gr/sq.m/d (d1-5) and Ida 12 mg/sq.m/d (d1-3). If patients did not have an HLA identical donor they were randomized to receive second course of consolidation either high dose Ara-C 3 gr/sq.m/d (d1, 3, 5) or G-CSF for collection of stem cells for the consecutive PBSCT.
| Condition | Intervention | Phase |
|---|---|---|
|
AML |
Drug: G-CSF |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase III, Randomized Multicenter Study of Induction With or Without Granulocyte Colony-Stimulating Factor in AML |
- response to induction [ Time Frame: 3 year ] [ Designated as safety issue: No ]
- overall survival [ Time Frame: 3 year ] [ Designated as safety issue: No ]
| Enrollment: | 260 |
| Study Start Date: | March 1996 |
| Study Completion Date: | January 2009 |
| Primary Completion Date: | March 2000 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: control
remission induction with cytosine arabinoside amd idarubicine
|
|
|
Experimental: G-CSF
G-CSF was administered starting on Day 8 until neutrophil recovery
|
Drug: G-CSF
Filgrastim(5 µg/kg intravenously over 30 minutes ) was administered starting from day 8 until neutrophil recovery
Other Name: Neupogen
|
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Newly diagnosed AML
- Age over 16
- Performance status greater than 60
- Previously untreated
- Peripheral blood white blood cell (WBC) count of less than (<) 0.5 x109/L, and/or marrow leukemic blasts< 20 % at 7th day of remission induction treatment
Exclusion Criteria:
- Previously treated
- Acute promyelocytic leukemia
- Age equal or younger than 15
Contacts and Locations More Information
No publications provided
| Responsible Party: | Meral Beksac MD, principal investigator, Turkish Leukemia Sutdy Group |
| ClinicalTrials.gov Identifier: | NCT00820976 History of Changes |
| Other Study ID Numbers: | TLG-AML-95-002 |
| Study First Received: | January 9, 2009 |
| Last Updated: | January 9, 2009 |
| Health Authority: | Turkey: Ministry of Health |
Keywords provided by Turkish Leukemia Study Group:
|
G-CSF AML survival |
Additional relevant MeSH terms:
|
Lenograstim Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013