Acute Myeloid LeukemiaPhase 3LAM-SA 2007NCT00590837
Adding Lomustine to Chemotherapy in Older Patients With Acute Myelogenous Leukemia (AML), and Allogeneic Transplantation for Patients From 60 to 65 Years Old
A Phase 3 study testing Lomustine in people with Acute Myeloid Leukemia, run by University Hospital, Bordeaux at 32 sites in France.
Trial summary
A multicenter randomized trial comparing induction therapy (IC: Idarubicin and Cytarabine, 5 + 7) to ICL (the same drugs plus lomustine (CCNU), 200 mg/m2 orally at day 1). Patients in complete remission (CR) will then receive a post-remission schedule with or without lomustine according to randomization. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- Lomustine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 459 participants
- Where
- 32 sitesFrance
- Study dates
- Feb 2008to Dec 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 60 years and older with de novo AML and non-poor cytogenetic features.
- Patients with no unfavourable cytogenetic (based on GOELAMS-BGMT criteria)
- Performance status and Sorror score < 3 .
- Signed and dated informed consent.
Who cannot join
- Acute promyelocytic leukemia.
- Patients with myeloproliferative syndromes prior to diagnosis of AML.
- Patients who previously had myelodysplastic syndrome.
- Positive serology for HIV.
- Patients with unfavourable cytogenetic
- Patients with an isolated medullary extra localization of their disease
Trial locations and contacts
32 sites in 1 country.
32 sites in 1 country
France32 sites
Services maladies du sang, cancérologie, Hôpital Sud, CHU Amiens
Amiens, 80054
Service des maladies du sang, Centre Hospitalier Universitaire d'Angers
Angers, 49033
Service Hématologie, Centre Hospitalier Annecy
Annecy, 74011
C.H Victor Dupouy
Argenteuil, 95100
Service Médecine Interne, Onco-Hématologie, Maladies Infectieuses, Hôpital Henri Duffaut, Centre Hospitalier Avignon
Avignon, 84000
Service Hématologie, Centre Hospitalier de la Côte Basque
Bayonne, 64109
Service Hématologie, Hôpital Minjoz
Besançon, 25030
Unité Hématologie, Centre Hospitalier Blois
Blois, 41016
Service des maladies du sang - Hôpital Haut-Lévêque
Bordeaux - Pessac, 33604
Service Hématologie, Hôpital Dr Duchenne
Boulogne-sur-Mer, 62321
Service Hématologie, Hôpital Augustin Morvan
Brest, 29609
Service Hématologie et Thérapie cellulaire, Pavillon Villemin Pasteur, CHU Clermont-Ferrand
Clermont-Ferrand, 63000
Service Oncologie - Hématologie, Hôpital Pasteur, Centre Hospitalier Colmar
Colmar, 68024
Service Hématologie Clinique, CHU Dijon Hôpital des enfants
Dijon, 21079
Service Hématologie Clinique, Hôpital Michallon, CHU de Grenoble
Grenoble, 38043
Service Onco-Hématologie 3, Institut Paoli Calmettes
Marseille, 13275
Service Hématologie Oncologie, CHR Metz-Thionville
Metz, 57038
Service Hématologie Oncologie, Hôpital Lapeyronie, CHU de Montpellier
Montpellier, 34295
Département d'hématologie, Hôpital E.Muller, Centre Hospitalier de Mulhouse
Mulhouse, 68070
Service Hématologie Clinique, CHU -Hôtel Dieu
Nantes, 44093
Service Hématologie Clinique, Hôpital Archet 1
Nice, 06202
Service Médecine B - Unité Onco-hématologique, CHU Caremeau
Nîmes, 30029
Service Oncologie Médicale, Hôpital de la Source
Orléans, 45067
Unité d'Hématologie, Hôpital Cochin
Paris, 75679
Service Hématologie, CHG Saint Jean
Perpignan, 66000
Service Hématologie Clinique, Hôpital Robert Debre
Reims, 51092
Service Hématologie Clinique, Hôpital Pontchaillou
Rennes, 35033
Service d'Hématologie, Institut de Cancérologhie de la Loire
Saint Priez En Jarez, 42270
Département d'Hématologie et d'Oncologie, Hôpital CHRU de Hautepierre
Strasbourg, 67098
Service Hématologie, Hôpital Purpan
Toulouse, 31059
Service Hématologie Clinique, Hôpital Bretonneau
Tours, 37044
Service Hématologie - Médecine Interne, Hôpitaux de Brabois
Vandœuvre-lès-Nancy, 54511
About this study
Official title: Randomized Prospective Study of Adding Lomustine to Idarubicin and Cytarabine for Induction and Post-remission Chemotherapy in Older Patients With Acute Myeloid Leukaemia, and Feasibility of Allogeneic Transplantation for Patients From 60 to 65 Years Old
A multicenter randomized trial comparing induction therapy (IC: Idarubicin and Cytarabine, 5 + 7) to ICL (the same drugs plus lomustine (CCNU), 200 mg/m2 orally at day 1). Patients in complete remission (CR) will then receive a post-remission schedule with or without lomustine according to randomization. Patients from 60 to 65 years old will be proposed to reduced conditioning allogeneic transplantation after first consolidation.
Read the detailed description
- Principal Objective: The primary objective of this study is to assess the ability of lomustine to increase the overall survival by adding lomustine to induction and post-remission chemotherapy.
- Secondary Objectives:
- To assess the ability of lomustine to increase the CR rate.
- To assess the ability of lomustine to increase the event-free survival.
- To evaluate the toxicity and side-effects of lomustine.
- To evaluate the feasibility of reduced conditioning allogeneic transplantation *between 60 and 65 years old.
- To evaluate prognostic factors.
- To evaluate QOL in elderly.
- Study design: Parallel
- Study plan:
- Induction therapy: Patients will be randomized to receive idarubicin (5d) plus cytarabine or the same drugs plus lomustine, the latter given at the dose of 200 mg/m2 orally at day 1.
- Consolidation therapy: After completing induction treatment, patients who are in complete remission will receive a course of consolidation therapy with idarubicin (3d) and subcutaneous cytarabine.
- Maintenance therapy: In all patients with persisting CR one month after completing consolidation: six courses of monthly combination chemotherapy (idarubicin (1d) and subcutaneous cytarabine) and then a continuous regimen of methotrexate and 6-mercaptopurine, for 6 months.
- Allogeneic transplantation: Patients between 60 and 65 years old with a full matched donor will receive after consolidation (if still in CR) an alloBMT with a reduced conditioning regimen of Fludarabine (3d) and TBI (2Gy).
- Number of subjects: 460
- Conditions
- Acute Myeloid Leukemia
- Being tested
- Lomustine
- Keywords
- AML, Chemotherapy, older, De novo AML
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LomustineDrug
Induction: chemotherapy + lomustine (CCNU), 200 mg/m2 orally at day 1.
Consolidation: chemotherapy + lomustine (CCNU), 80 mg orally at day 1.
Reinductions: chemotherapy + lomustine (CCNU), 40 mg orally at day 1.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Patients will be treated by adding lomustine to chemotherapy Receives: Drug: Lomustine |
| 2 | No intervention | Patients will be treated without adding lomustine to chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Measured: 1 year
Secondary outcomes (4)
Complete remission
Measured: 1 year
Event-free survival
Measured: 1 year
Prognostic factors
Measured: 1 year
Quality of Life (QOL)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2008 (estimated)
- Study startFeb 2008
- Primary completionDec 2012
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 459 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arnaud Pigneux, MD, PhD, Principal investigator, University Hospital Bordeaux, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00590837
- Sponsor's protocol ID
- CHUBX 2007/13
- Acronym
- LAM-SA 2007
- Status last verified
- Apr 2014
- First submitted
- 27 Dec 2007
- Last updated
- 2 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Appelbaum FR, Gundacker H, Head DR, Slovak ML, Willman CL, Godwin JE, Anderson JE, Petersdorf SH. Age and acute myeloid leukemia. Blood. 2006 May 1;107(9):3481-5. doi: 10.1182/blood-2005-09-3724. Epub 2006 Feb 2.
PubMed 16455952Sekeres MA, Stone R. Older adults with acute myeloid leukemia. Curr Oncol Rep. 2002 Sep;4(5):403-9. doi: 10.1007/s11912-002-0034-y.
PubMed 12162914Mayer RJ, Davis RB, Schiffer CA, Berg DT, Powell BL, Schulman P, Omura GA, Moore JO, McIntyre OR, Frei E 3rd. Intensive postremission chemotherapy in adults with acute myeloid leukemia. Cancer and Leukemia Group B. N Engl J Med. 1994 Oct 6;331(14):896-903. doi: 10.1056/NEJM199410063311402.
PubMed 8078551Stone RM, Berg DT, George SL, Dodge RK, Paciucci PA, Schulman P, Lee EJ, Moore JO, Powell BL, Schiffer CA. Granulocyte-macrophage colony-stimulating factor after initial chemotherapy for elderly patients with primary acute myelogenous leukemia. Cancer and Leukemia Group B. N Engl J Med. 1995 Jun 22;332(25):1671-7. doi: 10.1056/NEJM199506223322503.
PubMed 7760868Witz F, Sadoun A, Perrin MC, Berthou C, Briere J, Cahn JY, Lioure B, Witz B, Francois S, Desablens B, Pignon B, Le Prise PY, Audhuy B, Caillot D, Casassus P, Delain M, Christian B, Tellier Z, Polin V, Hurteloup P, Harousseau JL. A placebo-controlled study of recombinant human granulocyte-macrophage colony-stimulating factor administered during and after induction treatment for de novo acute myelogenous leukemia in elderly patients. Groupe Ouest Est Leucemies Aigues Myeloblastiques (GOELAM). Blood. 1998 Apr 15;91(8):2722-30.
PubMed 9531581Pigneux A, Perreau V, Jourdan E, Vey N, Dastugue N, Huguet F, Sotto JJ, Salmi LR, Ifrah N, Reiffers J. Adding lomustine to idarubicin and cytarabine for induction chemotherapy in older patients with acute myeloid leukemia: the BGMT 95 trial results. Haematologica. 2007 Oct;92(10):1327-34. doi: 10.3324/haematol.11068.
PubMed 18024370Takagi K. [Neurophysiological and clinical aspects of autonomic centers: introduction]. Nihon Seirigaku Zasshi. 1972 May;34(5):257-61. No abstract available. Japanese.
PubMed 4673036Gardin C, Turlure P, Fagot T, Thomas X, Terre C, Contentin N, Raffoux E, de Botton S, Pautas C, Reman O, Bourhis JH, Fenaux P, Castaigne S, Michallet M, Preudhomme C, de Revel T, Bordessoule D, Dombret H. Postremission treatment of elderly patients with acute myeloid leukemia in first complete remission after intensive induction chemotherapy: results of the multicenter randomized Acute Leukemia French Association (ALFA) 9803 trial. Blood. 2007 Jun 15;109(12):5129-35. doi: 10.1182/blood-2007-02-069666. Epub 2007 Mar 6.
PubMed 17341661Hegenbart U, Niederwieser D, Sandmaier BM, Maris MB, Shizuru JA, Greinix H, Cordonnier C, Rio B, Gratwohl A, Lange T, Al-Ali H, Storer B, Maloney D, McSweeney P, Chauncey T, Agura E, Bruno B, Maziarz RT, Petersen F, Storb R. Treatment for acute myelogenous leukemia by low-dose, total-body, irradiation-based conditioning and hematopoietic cell transplantation from related and unrelated donors. J Clin Oncol. 2006 Jan 20;24(3):444-53. doi: 10.1200/JCO.2005.03.1765. Epub 2005 Dec 12.
PubMed 16344316Largeaud L, Cornillet-Lefebvre P, Hamel JF, Dumas PY, Prade N, Dufrechou S, Plenecassagnes J, Luquet I, Blanchet O, Banos A, Bene MC, Bernard M, Bertoli S, Bonmati C, Fornecker LM, Guieze R, Haddaoui L, Hunault M, Ianotto JC, Jourdan E, Ojeda M, Peterlin P, Vey N, Zerazhi H, Yosr H, Mineur A, Cahn JY, Ifrah N, Recher C, Pigneux A, Delabesse E; French Innovative Leukemia Organization (FILO). Lomustine is beneficial to older AML with ELN2017 adverse risk profile and intermediate karyotype: a FILO study. Leukemia. 2021 May;35(5):1291-1300. doi: 10.1038/s41375-020-01031-1. Epub 2020 Sep 18.
PubMed 32943750
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Prospective Study of Adding Lomustine to Idarubicin and Cytarabine for Induction and Post-remission Chemotherapy in Older Patients With Acute Myeloid Leukaemia, and Feasibility of Allogeneic Transplantation for Patients From 60 to 65 Years Old
- ClinicalTrials.gov ID
- NCT00590837
- Acronym / sponsor ID
- LAM-SA 2007 / CHUBX 2007/13
- Conditions
- Acute Myeloid Leukemia
- Keywords
- AML, Chemotherapy, older, De novo AML
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 459 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 11 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A multicenter randomized trial comparing induction therapy (IC: Idarubicin and Cytarabine, 5 + 7) to ICL (the same drugs plus lomustine (CCNU), 200 mg/m2 orally at day 1). Patients in complete remission (CR) will then receive a post-remission schedule with or without lomustine according to randomization. Patients from 60 to 65 years old will be proposed to reduced conditioning allogeneic transplantation after first consolidation.
Detailed description
- Principal Objective: The primary objective of this study is to assess the ability of lomustine to increase the overall survival by adding lomustine to induction and post-remission chemotherapy.
- Secondary Objectives:
- To assess the ability of lomustine to increase the CR rate.
- To assess the ability of lomustine to increase the event-free survival.
- To evaluate the toxicity and side-effects of lomustine.
- To evaluate the feasibility of reduced conditioning allogeneic transplantation *between 60 and 65 years old.
- To evaluate prognostic factors.
- To evaluate QOL in elderly.
- Study design: Parallel
- Study plan:
- Induction therapy: Patients will be randomized to receive idarubicin (5d) plus cytarabine or the same drugs plus lomustine, the latter given at the dose of 200 mg/m2 orally at day 1.
- Consolidation therapy: After completing induction treatment, patients who are in complete remission will receive a course of consolidation therapy with idarubicin (3d) and subcutaneous cytarabine.
- Maintenance therapy: In all patients with persisting CR one month after completing consolidation: six courses of monthly combination chemotherapy (idarubicin (1d) and subcutaneous cytarabine) and then a continuous regimen of methotrexate and 6-mercaptopurine, for 6 months.
- Allogeneic transplantation: Patients between 60 and 65 years old with a full matched donor will receive after consolidation (if still in CR) an alloBMT with a reduced conditioning regimen of Fludarabine (3d) and TBI (2Gy).
- Number of subjects: 460
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: LomustinePatients will be treated by adding lomustine to chemotherapy |
| 2 | No intervention | –Patients will be treated without adding lomustine to chemotherapy |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged 60 years and older with de novo AML and non-poor cytogenetic features.
- Patients with no unfavourable cytogenetic (based on GOELAMS-BGMT criteria)
- Performance status and Sorror score < 3 .
- Signed and dated informed consent.
Key exclusion criteria (6 listed)
- Acute promyelocytic leukemia.
- Patients with myeloproliferative syndromes prior to diagnosis of AML.
- Patients who previously had myelodysplastic syndrome.
- Positive serology for HIV.
- Patients with unfavourable cytogenetic
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LomustineInduction: chemotherapy + lomustine (CCNU), 200 mg/m2 orally at day 1. Consolidation: chemotherapy + lomustine (CCNU), 80 mg orally at day 1. Reinductions: chemotherapy + lomustine (CCNU), 40 mg orally at day 1. | Drug | 1 |
Primary outcome
Overall Survival
Time frame: 1 year
4 secondary outcomes
Complete remission
Time frame: 1 year
Event-free survival
Time frame: 1 year
Prognostic factors
Time frame: 1 year
Quality of Life (QOL)
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2014.
- Background: PubMed 16455952Appelbaum FR, Gundacker H, Head DR, Slovak ML, Willman CL, Godwin JE, Anderson JE, Petersdorf SH. Age and acute myeloid leukemia. Blood. 2006 May 1;107(9):3481-5. doi: 10.1182/blood-2005-09-3724. Epub 2006 Feb 2.
- Background: PubMed 12162914Sekeres MA, Stone R. Older adults with acute myeloid leukemia. Curr Oncol Rep. 2002 Sep;4(5):403-9. doi: 10.1007/s11912-002-0034-y.
- Background: PubMed 8078551Mayer RJ, Davis RB, Schiffer CA, Berg DT, Powell BL, Schulman P, Omura GA, Moore JO, McIntyre OR, Frei E 3rd. Intensive postremission chemotherapy in adults with acute myeloid leukemia. Cancer and Leukemia Group B. N Engl J Med. 1994 Oct 6;331(14):896-903. doi: 10.1056/NEJM199410063311402.
- Background: PubMed 7760868Stone RM, Berg DT, George SL, Dodge RK, Paciucci PA, Schulman P, Lee EJ, Moore JO, Powell BL, Schiffer CA. Granulocyte-macrophage colony-stimulating factor after initial chemotherapy for elderly patients with primary acute myelogenous leukemia. Cancer and Leukemia Group B. N Engl J Med. 1995 Jun 22;332(25):1671-7. doi: 10.1056/NEJM199506223322503.
- Background: PubMed 9531581Witz F, Sadoun A, Perrin MC, Berthou C, Briere J, Cahn JY, Lioure B, Witz B, Francois S, Desablens B, Pignon B, Le Prise PY, Audhuy B, Caillot D, Casassus P, Delain M, Christian B, Tellier Z, Polin V, Hurteloup P, Harousseau JL. A placebo-controlled study of recombinant human granulocyte-macrophage colony-stimulating factor administered during and after induction treatment for de novo acute myelogenous leukemia in elderly patients. Groupe Ouest Est Leucemies Aigues Myeloblastiques (GOELAM). Blood. 1998 Apr 15;91(8):2722-30.
- Background: PubMed 18024370Pigneux A, Perreau V, Jourdan E, Vey N, Dastugue N, Huguet F, Sotto JJ, Salmi LR, Ifrah N, Reiffers J. Adding lomustine to idarubicin and cytarabine for induction chemotherapy in older patients with acute myeloid leukemia: the BGMT 95 trial results. Haematologica. 2007 Oct;92(10):1327-34. doi: 10.3324/haematol.11068.
- Background: PubMed 4673036Takagi K. [Neurophysiological and clinical aspects of autonomic centers: introduction]. Nihon Seirigaku Zasshi. 1972 May;34(5):257-61. No abstract available. Japanese.
- Background: PubMed 17341661Gardin C, Turlure P, Fagot T, Thomas X, Terre C, Contentin N, Raffoux E, de Botton S, Pautas C, Reman O, Bourhis JH, Fenaux P, Castaigne S, Michallet M, Preudhomme C, de Revel T, Bordessoule D, Dombret H. Postremission treatment of elderly patients with acute myeloid leukemia in first complete remission after intensive induction chemotherapy: results of the multicenter randomized Acute Leukemia French Association (ALFA) 9803 trial. Blood. 2007 Jun 15;109(12):5129-35. doi: 10.1182/blood-2007-02-069666. Epub 2007 Mar 6.
- Background: PubMed 16344316Hegenbart U, Niederwieser D, Sandmaier BM, Maris MB, Shizuru JA, Greinix H, Cordonnier C, Rio B, Gratwohl A, Lange T, Al-Ali H, Storer B, Maloney D, McSweeney P, Chauncey T, Agura E, Bruno B, Maziarz RT, Petersen F, Storb R. Treatment for acute myelogenous leukemia by low-dose, total-body, irradiation-based conditioning and hematopoietic cell transplantation from related and unrelated donors. J Clin Oncol. 2006 Jan 20;24(3):444-53. doi: 10.1200/JCO.2005.03.1765. Epub 2005 Dec 12.
- Derived from this study: PubMed 32943750Largeaud L, Cornillet-Lefebvre P, Hamel JF, Dumas PY, Prade N, Dufrechou S, Plenecassagnes J, Luquet I, Blanchet O, Banos A, Bene MC, Bernard M, Bertoli S, Bonmati C, Fornecker LM, Guieze R, Haddaoui L, Hunault M, Ianotto JC, Jourdan E, Ojeda M, Peterlin P, Vey N, Zerazhi H, Yosr H, Mineur A, Cahn JY, Ifrah N, Recher C, Pigneux A, Delabesse E; French Innovative Leukemia Organization (FILO). Lomustine is beneficial to older AML with ELN2017 adverse risk profile and intermediate karyotype: a FILO study. Leukemia. 2021 May;35(5):1291-1300. doi: 10.1038/s41375-020-01031-1. Epub 2020 Sep 18.
Related trials for Acute Myeloid Leukemia
RecruitingPhase 1
A Study of CHM-029 in Participants With NPM1 Mutated, KMT2A or NUP98 Rearranged AML
AML (Acute Myeloid Leukemia)
RecruitingPhase 2
Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
RecruitingPhase 1/2
Venetoclax and CLAG-M for the Treatment of Acute Myeloid Leukemia and High-Grade Myeloid Neoplasms
Acute Biphenotypic Leukemia, Acute Myeloid Leukemia
Not yet recruitingPhase 1
ATRN-119 in Combination With Decitabine in Patients With TP53-Mutated AML or Higher-Risk MDS
Acute Myeloid Leukemia, High-risk Myelodysplastic Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arnaud Pigneux, MD, PhD principal investigator
University Hospital Bordeaux, France
32 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lomustine in people with Acute Myeloid Leukemia, run by University Hospital, Bordeaux at 32 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00590837, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2014.