Chronic Myeloid LeukaemiaPhase 4NCT00390897
Glivec® (Imatinib Mesylate, STI571) in Monotherapy Versus Glivec®-Interferon Alpha in the Treatment of Chronic-Phase Chronic Myeloid Leukaemia
A Phase 4 study testing Glivec and Interferon in people with Chronic Myeloid Leukaemia, run by PETHEMA Foundation at 51 sites in Spain.
Trial summary
To compare the complete cytogenetic response rate in patients with newly-diagnosed chronic-phase chronic myeloid leukaemia treated with Glivec® alone or in combination with interferon at low doses Read more about this study
- Who is it for?
- Ages 18 to 72 years
- Conditions the study is for
- Chronic Myeloid Leukaemia
- What is being tested?
- Glivec and Interferon
- How many people
- 360 participants
- Where
- 51 sitesSpain
- Study dates
- Jul 2003to Dec 2007
- Phase
- Phase 4
- 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 18 to 72 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with newly-diagnosed chronic-phase Ph-positive chronic myeloid leukaemia (maximum 3 months as of the diagnosis of the disease, with the date of the cytogenetic study regarded as such).
- Age between 18 and 72 years (both included).
- Performance status < 2 on the ECOG scale (see Annex 3).
- Secure written or oral informed consent in the presence of a witness and consent for biological samples (annexes 5 and 6).
Who cannot join
- Criteria of acceleration or blastic crisis (see Annex 7).
- When there is a compatible family donor in patients aged under 40 years or a non-relative donor in patients aged under 30 years (in whom allogenic transplant is still regarded as first-line treatment), the possibility of performing an allogenic transplant as first therapeutic option should be considered. In any case, as this aspect is still a matter of debate, it is left up to each group to take the relevant decision depending on the institution's policy.
- Administration of other treatments before inclusion in the protocol (a maximum of 3 months of monotherapy with hydroxyurea is permitted).
- Altered hepatic or renal function (SGOT, SGPT, total bilirubin and creatinine > 1.5 times the upper limit of normality).
- Uncontrolled diseases, such as thyroidal dysfunction, diabetes mellitus, angina pectoralis, serious heart failure (functional class III/IV of the New York Heart Association classification), neuropsychiatric infection or disease (see annex 15).
- Positive serology for HIV.
- Record of cancer in the last 5 years (barring basal cell skin carcinoma and cervical carcinoma in situ).
- Pregnancy or breastfeeding
Trial locations and contacts
51 sites in 1 country.
51 sites in 1 country
Spain51 sites
Hospital Juan Canalejo
A Coruña, La Coruña
Hospital de Alcorcón
Alcorcón, Madrid
Hospital Ntra. Sra. Sonsoles
Ávila, Avila
Hospital Clínic
Barcelona, Barcelona
Hospital del Mar
Barcelona, Barcelona
Hospital Sant pau
Barcelona, Barcelona
Hospital Universitario "Germans Trias i Pujol"
Barcelona, Barcelona
Hospital vall d'Hebrón
Barcelona, Barcelona
Institut Català d'oncología
Barcelona, Barcelona
Hospital San Pedro de Alcántara
Cáceres
Complejo Hospitalario Reina Sofía
Córdoba, Córdoba
Hospital Ruiz de Alda
Granada, Granada
Hospital Juan Ramón Jiménez
Huelva, Huelva
Hospital Médico Quirúrgico Ciudad de Jaén
Jaén, Jaen
Hospital general de Jerez de la Frontera
Jerez de la Frontera
Hospital Arnau de Vilanova
Lleida, Lleida
Clínica La Concepción
Madrid, Madrid
Clínica Puerta de Hierro
Madrid, Madrid
Hospital Clínico San Carlos de Madrid
Madrid, Madrid
Hospital de Fuenlabrada
Madrid, Madrid
Hospital Doce de Octubre
Madrid, Madrid
Hospital Gregorio Marañón
Madrid, Madrid
Hospital Ramón y Cajal
Madrid, Madrid
Hospital Universitario Princcipe de Asturias
Madrid, Madrid
. Hospital Clínico Universitario Virgen de la Victoria
Málaga, Málaga
Hospital Carlos Haya
Málaga, Málaga
Hospital de Mataró
Mataró, Barcelona
Hospital Universitario Morales Meseguer, Murcia
Murcia, Murcia
Hospital comarcal de Valdeorras
O'Barco de Valdeorras
Hospital Central de Asturias
Oviedo, Principality of Asturias
Hospital del Río Carrión
Palencia, Palencia
Hospital Son Dureta
Palma de Mallorca, Balearic Islands
Hospital Son Llatzer
Palma de Mallorca, Mallorca
Clínica Universitaria de Navarra
Pamplona, Navarre
Hospital de Navarra
Pamplona, Navarre
Corporació Sanitària Parc Taulí
Sabadell, Barcelona
Hospital Clínico Universitario de Salamanca
Salamanca, Salamanca
Hospital Universitario de Canarias
Santa Cruz de Tenerife, Canary Islands
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria
Hospital General
Segovia, Segovia
Hospital Universitario Virgen del Rocío
Seville, Sevilla
Hospital Joan XXIII
Tarragona, Tarragona
Hospital Mútua de Terrassa
Terrassa, Barcelona
Hospital Verge de la Cinta
Tortosa, Tarragona
Hospital Clínico Universitario
Valencia, Valencia
Hospital dr. Peset
Valencia, Valencia
Hospital General Universitario
Valencia, Valencia
Hospital Universitario la Fe
Valencia, Valencia
Hospital Meixoeiro
Vigo, Vigo
Hospital Xeral
Vigo, Vigo
Hospital Virgen de la Concha
Zamora, Zamora
About this study
Official title: Randomised Multicentre Phase IV Study to Compare Glivec® (Imatinib Mesylate, STI571) in Monotherapy Versus Glivec® in Combination With Interferon Alpha at Low Doses in the Treatment of Newly-Diagnosed Chronic-Phase Chronic Myeloid Leukaemia
To compare the complete cytogenetic response rate in patients with newly-diagnosed chronic-phase chronic myeloid leukaemia treated with Glivec® alone or in combination with interferon at low doses
Read the detailed description
Open, prospective, multicentre, phase IV, comparative and randomised study
- Conditions
- Chronic Myeloid Leukaemia
- Being tested
- Glivec, Interferon
- Keywords
- chronic myeloid leukaemia, Glivec, Interferon
- Medical subject headings
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlivecDrug
InterferonDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The fundamental objective of this study is to compare the therapeutic efficacy of Glivec® given in monotherapy (providing for dose scaling according to the response obtained at different periods of time from the beginning) in combination with standard in
The median survival of patients with CML is close to 7 years.
One year and a half after diagnosis, the rate of progression to the acceleration phase and blastic crisis is very low (3.3%) in patients treated with Glivec® as first line.
With the treatments available hitherto, the achievement of a major cytogenetic response and above all cytogenetic response translates into a prolongation of survival.
Therefore, taking into account that the rate of complete cytogenetic responses to Glivec® in newly-diagnosed CML is 76% after 18 months of treatment (see table I), the fundamental objective of the study will be to compare the rate of complete cytogenetic
Secondary outcomes (7)
The time until complete cytogenetic responses are obtained
Rate of major cytogenetic responses
Rate of molecular responses
Time to the loss of cytogenetic, haematological or molecular response
Time to the progression of the disease to the phases of acceleration and blastic crisis (analysed according to intention to treat)
Survival (analysed according to intention to treat)
Haematological and non haematological tolerance and safety
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2006 (estimated)
- Study startJul 2003
- Primary completionOct 2006
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Chronic Myeloid LeukaemiaStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 360 participants
Sponsor and investigators
- Lead sponsor
- PETHEMA Foundation
- Sponsor type
- University, hospital or other
- Investigators
- Cervantes Francisco, Dr, Study chair, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00390897
- Sponsor's protocol ID
- LMC/PETHEMA
- Other IDs
- 03-0289
- Status last verified
- Nov 2008
- First submitted
- 20 Oct 2006
- Last updated
- 27 Nov 2008
- Results posted
- No
Publications
RUDKIN CT, HUNGERFORD DA, NOWELL PC. DNA CONTENTS OF CHROMOSOME PH1 AND CHROMOSOME 21 IN HUMAN CHRONIC GRANULOCYTIC LEUKEMIA. Science. 1964 Jun 5;144(3623):1229-31. doi: 10.1126/science.144.3623.1229.
PubMed 14150328Rowley JD. Letter: A new consistent chromosomal abnormality in chronic myelogenous leukaemia identified by quinacrine fluorescence and Giemsa staining. Nature. 1973 Jun 1;243(5405):290-3. doi: 10.1038/243290a0. No abstract available.
PubMed 4126434Heisterkamp N, Jenster G, ten Hoeve J, Zovich D, Pattengale PK, Groffen J. Acute leukaemia in bcr/abl transgenic mice. Nature. 1990 Mar 15;344(6263):251-3. doi: 10.1038/344251a0.
PubMed 2179728Daley GQ, Van Etten RA, Baltimore D. Induction of chronic myelogenous leukemia in mice by the P210bcr/abl gene of the Philadelphia chromosome. Science. 1990 Feb 16;247(4944):824-30. doi: 10.1126/science.2406902.
PubMed 2406902Goldman JM, Szydlo R, Horowitz MM, Gale RP, Ash RC, Atkinson K, Dicke KA, Gluckman E, Herzig RH, Marmont A, et al. Choice of pretransplant treatment and timing of transplants for chronic myelogenous leukemia in chronic phase. Blood. 1993 Oct 1;82(7):2235-8.
PubMed 8400272Italian Cooperative Study Group on Chronic Myeloid Leukemia; Tura S, Baccarani M, Zuffa E, Russo D, Fanin R, Zaccaria A, Fiacchini M. Interferon alfa-2a as compared with conventional chemotherapy for the treatment of chronic myeloid leukemia. N Engl J Med. 1994 Mar 24;330(12):820-5. doi: 10.1056/NEJM199403243301204.
PubMed 8114834Druker BJ, Talpaz M, Resta DJ, Peng B, Buchdunger E, Ford JM, Lydon NB, Kantarjian H, Capdeville R, Ohno-Jones S, Sawyers CL. Efficacy and safety of a specific inhibitor of the BCR-ABL tyrosine kinase in chronic myeloid leukemia. N Engl J Med. 2001 Apr 5;344(14):1031-7. doi: 10.1056/NEJM200104053441401.
PubMed 11287972Savage DG, Antman KH. Imatinib mesylate--a new oral targeted therapy. N Engl J Med. 2002 Feb 28;346(9):683-93. doi: 10.1056/NEJMra013339. No abstract available.
PubMed 11870247Kantarjian H, Sawyers C, Hochhaus A, Guilhot F, Schiffer C, Gambacorti-Passerini C, Niederwieser D, Resta D, Capdeville R, Zoellner U, Talpaz M, Druker B, Goldman J, O'Brien SG, Russell N, Fischer T, Ottmann O, Cony-Makhoul P, Facon T, Stone R, Miller C, Tallman M, Brown R, Schuster M, Loughran T, Gratwohl A, Mandelli F, Saglio G, Lazzarino M, Russo D, Baccarani M, Morra E; International STI571 CML Study Group. Hematologic and cytogenetic responses to imatinib mesylate in chronic myelogenous leukemia. N Engl J Med. 2002 Feb 28;346(9):645-52. doi: 10.1056/NEJMoa011573.
PubMed 11870241O'Brien SG, Guilhot F, Larson RA, Gathmann I, Baccarani M, Cervantes F, Cornelissen JJ, Fischer T, Hochhaus A, Hughes T, Lechner K, Nielsen JL, Rousselot P, Reiffers J, Saglio G, Shepherd J, Simonsson B, Gratwohl A, Goldman JM, Kantarjian H, Taylor K, Verhoef G, Bolton AE, Capdeville R, Druker BJ; IRIS Investigators. Imatinib compared with interferon and low-dose cytarabine for newly diagnosed chronic-phase chronic myeloid leukemia. N Engl J Med. 2003 Mar 13;348(11):994-1004. doi: 10.1056/NEJMoa022457.
PubMed 12637609Kantarjian HM, Talpaz M, O'Brien S, Giles F, Garcia-Manero G, Faderl S, Thomas D, Shan J, Rios MB, Cortes J. Dose escalation of imatinib mesylate can overcome resistance to standard-dose therapy in patients with chronic myelogenous leukemia. Blood. 2003 Jan 15;101(2):473-5. doi: 10.1182/blood-2002-05-1451. Epub 2002 Sep 12.
PubMed 12393385Rea D, Legros L, Raffoux E, Thomas X, Turlure P, Maury S, Dupriez B, Pigneux A, Choufi B, Reman O, Stephane D, Royer B, Vigier M, Ojeda-Uribe M, Recher C, Dombret H, Huguet F, Rousselot P; Intergroupe Francais des Leucemies Myeloides Chronique; Group for Research in Adult Acute Lymphoblastic Leukemia. High-dose imatinib mesylate combined with vincristine and dexamethasone (DIV regimen) as induction therapy in patients with resistant Philadelphia-positive acute lymphoblastic leukemia and lymphoid blast crisis of chronic myeloid leukemia. Leukemia. 2006 Mar;20(3):400-3. doi: 10.1038/sj.leu.2404115.
PubMed 16437142Deng M, Daley GQ. Expression of interferon consensus sequence binding protein induces potent immunity against BCR/ABL-induced leukemia. Blood. 2001 Jun 1;97(11):3491-7. doi: 10.1182/blood.v97.11.3491.
PubMed 11369642Bhatia R, Wayner EA, McGlave PB, Verfaillie CM. Interferon-alpha restores normal adhesion of chronic myelogenous leukemia hematopoietic progenitors to bone marrow stroma by correcting impaired beta 1 integrin receptor function. J Clin Invest. 1994 Jul;94(1):384-91. doi: 10.1172/JCI117333.
PubMed 7518835Thiesing JT, Ohno-Jones S, Kolibaba KS, Druker BJ. Efficacy of STI571, an abl tyrosine kinase inhibitor, in conjunction with other antileukemic agents against bcr-abl-positive cells. Blood. 2000 Nov 1;96(9):3195-9.
PubMed 11050003
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Multicentre Phase IV Study to Compare Glivec® (Imatinib Mesylate, STI571) in Monotherapy Versus Glivec® in Combination With Interferon Alpha at Low Doses in the Treatment of Newly-Diagnosed Chronic-Phase Chronic Myeloid Leukaemia
- ClinicalTrials.gov ID
- NCT00390897
- Acronym / sponsor ID
- LMC/PETHEMA
- Conditions
- Chronic Myeloid Leukaemia
- Keywords
- chronic myeloid leukaemia, Glivec, Interferon
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants
- Lead sponsor
- PETHEMA FoundationUniversity, hospital or other
- Study start
- Jul 2003
- Primary completion
- Oct 2006 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 23 Oct 2006 (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.
To compare the complete cytogenetic response rate in patients with newly-diagnosed chronic-phase chronic myeloid leukaemia treated with Glivec® alone or in combination with interferon at low doses
Detailed description
Open, prospective, multicentre, phase IV, comparative and randomised study
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 72 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with newly-diagnosed chronic-phase Ph-positive chronic myeloid leukaemia (maximum 3 months as of the diagnosis of the disease, with the date of the cytogenetic study regarded as such).
- Age between 18 and 72 years (both included).
- Performance status < 2 on the ECOG scale (see Annex 3).
- Secure written or oral informed consent in the presence of a witness and consent for biological samples (annexes 5 and 6).
Key exclusion criteria (8 listed)
- Criteria of acceleration or blastic crisis (see Annex 7).
- When there is a compatible family donor in patients aged under 40 years or a non-relative donor in patients aged under 30 years (in whom allogenic transplant is still regarded as first-line treatment), the possibility of performing an allogenic transplant as first therapeutic option should be considered. In any case, as this aspect is still a matter of debate, it is left up to each group to take the relevant decision depending on the institution's policy.
- Administration of other treatments before inclusion in the protocol (a maximum of 3 months of monotherapy with hydroxyurea is permitted).
- Altered hepatic or renal function (SGOT, SGPT, total bilirubin and creatinine > 1.5 times the upper limit of normality).
- Uncontrolled diseases, such as thyroidal dysfunction, diabetes mellitus, angina pectoralis, serious heart failure (functional class III/IV of the New York Heart Association classification), neuropsychiatric infection or disease (see annex 15).
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 |
|---|---|---|
| Glivec | Drug | – |
| Interferon | Drug | – |
Primary outcome
The fundamental objective of this study is to compare the therapeutic efficacy of Glivec® given in monotherapy (providing for dose scaling according to the response obtained at different periods of time from the beginning) in combination with standard in
The median survival of patients with CML is close to 7 years.
One year and a half after diagnosis, the rate of progression to the acceleration phase and blastic crisis is very low (3.3%) in patients treated with Glivec® as first line.
With the treatments available hitherto, the achievement of a major cytogenetic response and above all cytogenetic response translates into a prolongation of survival.
Therefore, taking into account that the rate of complete cytogenetic responses to Glivec® in newly-diagnosed CML is 76% after 18 months of treatment (see table I), the fundamental objective of the study will be to compare the rate of complete cytogenetic
7 secondary outcomes
The time until complete cytogenetic responses are obtained
Rate of major cytogenetic responses
Rate of molecular responses
Time to the loss of cytogenetic, haematological or molecular response
Time to the progression of the disease to the phases of acceleration and blastic crisis (analysed according to intention to treat)
Survival (analysed according to intention to treat)
Haematological and non haematological tolerance and safety
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 27 Nov 2008.
- Background: PubMed 14150328RUDKIN CT, HUNGERFORD DA, NOWELL PC. DNA CONTENTS OF CHROMOSOME PH1 AND CHROMOSOME 21 IN HUMAN CHRONIC GRANULOCYTIC LEUKEMIA. Science. 1964 Jun 5;144(3623):1229-31. doi: 10.1126/science.144.3623.1229.
- Background: PubMed 4126434Rowley JD. Letter: A new consistent chromosomal abnormality in chronic myelogenous leukaemia identified by quinacrine fluorescence and Giemsa staining. Nature. 1973 Jun 1;243(5405):290-3. doi: 10.1038/243290a0. No abstract available.
- Background: PubMed 2179728Heisterkamp N, Jenster G, ten Hoeve J, Zovich D, Pattengale PK, Groffen J. Acute leukaemia in bcr/abl transgenic mice. Nature. 1990 Mar 15;344(6263):251-3. doi: 10.1038/344251a0.
- Background: PubMed 2406902Daley GQ, Van Etten RA, Baltimore D. Induction of chronic myelogenous leukemia in mice by the P210bcr/abl gene of the Philadelphia chromosome. Science. 1990 Feb 16;247(4944):824-30. doi: 10.1126/science.2406902.
- Background: PubMed 8400272Goldman JM, Szydlo R, Horowitz MM, Gale RP, Ash RC, Atkinson K, Dicke KA, Gluckman E, Herzig RH, Marmont A, et al. Choice of pretransplant treatment and timing of transplants for chronic myelogenous leukemia in chronic phase. Blood. 1993 Oct 1;82(7):2235-8.
- Background: PubMed 8114834Italian Cooperative Study Group on Chronic Myeloid Leukemia; Tura S, Baccarani M, Zuffa E, Russo D, Fanin R, Zaccaria A, Fiacchini M. Interferon alfa-2a as compared with conventional chemotherapy for the treatment of chronic myeloid leukemia. N Engl J Med. 1994 Mar 24;330(12):820-5. doi: 10.1056/NEJM199403243301204.
- Background: PubMed 11287972Druker BJ, Talpaz M, Resta DJ, Peng B, Buchdunger E, Ford JM, Lydon NB, Kantarjian H, Capdeville R, Ohno-Jones S, Sawyers CL. Efficacy and safety of a specific inhibitor of the BCR-ABL tyrosine kinase in chronic myeloid leukemia. N Engl J Med. 2001 Apr 5;344(14):1031-7. doi: 10.1056/NEJM200104053441401.
- Background: PubMed 11870247Savage DG, Antman KH. Imatinib mesylate--a new oral targeted therapy. N Engl J Med. 2002 Feb 28;346(9):683-93. doi: 10.1056/NEJMra013339. No abstract available.
- Background: PubMed 11870241Kantarjian H, Sawyers C, Hochhaus A, Guilhot F, Schiffer C, Gambacorti-Passerini C, Niederwieser D, Resta D, Capdeville R, Zoellner U, Talpaz M, Druker B, Goldman J, O'Brien SG, Russell N, Fischer T, Ottmann O, Cony-Makhoul P, Facon T, Stone R, Miller C, Tallman M, Brown R, Schuster M, Loughran T, Gratwohl A, Mandelli F, Saglio G, Lazzarino M, Russo D, Baccarani M, Morra E; International STI571 CML Study Group. Hematologic and cytogenetic responses to imatinib mesylate in chronic myelogenous leukemia. N Engl J Med. 2002 Feb 28;346(9):645-52. doi: 10.1056/NEJMoa011573.
- Background: PubMed 12637609O'Brien SG, Guilhot F, Larson RA, Gathmann I, Baccarani M, Cervantes F, Cornelissen JJ, Fischer T, Hochhaus A, Hughes T, Lechner K, Nielsen JL, Rousselot P, Reiffers J, Saglio G, Shepherd J, Simonsson B, Gratwohl A, Goldman JM, Kantarjian H, Taylor K, Verhoef G, Bolton AE, Capdeville R, Druker BJ; IRIS Investigators. Imatinib compared with interferon and low-dose cytarabine for newly diagnosed chronic-phase chronic myeloid leukemia. N Engl J Med. 2003 Mar 13;348(11):994-1004. doi: 10.1056/NEJMoa022457.
- Background: PubMed 12393385Kantarjian HM, Talpaz M, O'Brien S, Giles F, Garcia-Manero G, Faderl S, Thomas D, Shan J, Rios MB, Cortes J. Dose escalation of imatinib mesylate can overcome resistance to standard-dose therapy in patients with chronic myelogenous leukemia. Blood. 2003 Jan 15;101(2):473-5. doi: 10.1182/blood-2002-05-1451. Epub 2002 Sep 12.
- Background: PubMed 16437142Rea D, Legros L, Raffoux E, Thomas X, Turlure P, Maury S, Dupriez B, Pigneux A, Choufi B, Reman O, Stephane D, Royer B, Vigier M, Ojeda-Uribe M, Recher C, Dombret H, Huguet F, Rousselot P; Intergroupe Francais des Leucemies Myeloides Chronique; Group for Research in Adult Acute Lymphoblastic Leukemia. High-dose imatinib mesylate combined with vincristine and dexamethasone (DIV regimen) as induction therapy in patients with resistant Philadelphia-positive acute lymphoblastic leukemia and lymphoid blast crisis of chronic myeloid leukemia. Leukemia. 2006 Mar;20(3):400-3. doi: 10.1038/sj.leu.2404115.
- Spanish association of HaematologyLink provided by the sponsor.
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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.
Cervantes Francisco, Dr study chair
Hospital Clinic of Barcelona
51 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Glivec and Interferon in people with Chronic Myeloid Leukaemia, run by PETHEMA Foundation at 51 sites in Spain.
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 8 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 27 Nov 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 51 sites in Spain. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
The fundamental objective of this study is to compare the therapeutic efficacy of Glivec® given in monotherapy (providing for dose scaling according to the response obtained at different periods of time from the beginning) in combination with standard in. The study lists 5 primary outcomes in all. 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 NCT00390897, which also lists 21 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 27 Nov 2008.