Glivec® (Imatinib Mesylate, STI571) in Monotherapy Versus Glivec®-Interferon Alpha in the Treatment of Chronic-Phase Chronic Myeloid Leukaemia

Sponsor

PETHEMA Foundation (Other)

Overall Status

Completed

CT.gov ID

NCT00390897

Collaborator

(none)

360

Enrollment

Locations

Duration (Months)

7.1

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Chronic Myeloid Leukaemia	Drug: Glivec Drug: Interferon	Phase 4

Detailed Description

Open, prospective, multicentre, phase IV, comparative and randomised study

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Jul 1, 2003

Actual Primary Completion Date :

Oct 1, 2006

Actual Study Completion Date :

Dec 1, 2007

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 72 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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).

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country
1	Hospital Central de Asturias	Oviedo	Asturias	Spain
2	Hospital de Mataró	Mataró	Barcelona	Spain
3	Corporació Sanitària Parc Taulí	Sabadell	Barcelona	Spain
4	Hospital Mútua de Terrassa	Terrassa	Barcelona	Spain
5	Hospital Universitario de Canarias	Tenerife	Canarias	Spain
6	Hospital Son Dureta	Palma de Mallorca	Illes balears	Spain
7	Hospital de Alcorcón	Alcorcón	Madrid	Spain
8	Hospital Son Llatzer	Palma de Mallorca	Mallorca	Spain
9	Clínica Universitaria de Navarra	Pamplona	Navarra	Spain
10	Hospital de Navarra	Pamplona	Navarra	Spain
11	Hospital Verge de la Cinta	Tortosa	Tarragona	Spain
12	Hospital Ntra. Sra. Sonsoles	Avila		Spain
13	Hospital Clínic	Barcelona		Spain
14	Hospital del Mar	Barcelona		Spain
15	Hospital Sant pau	Barcelona		Spain
16	Hospital Universitario "Germans Trias i Pujol"	Barcelona		Spain
17	Hospital vall d'Hebrón	Barcelona		Spain
18	Institut Català d'oncología	Barcelona		Spain
19	Hospital San Pedro de Alcántara	Cáceres		Spain
20	Complejo Hospitalario Reina Sofía	Córdoba		Spain
21	Hospital Ruiz de Alda	Granada		Spain
22	Hospital Juan Ramón Jiménez	Huelva		Spain
23	Hospital Médico Quirúrgico Ciudad de Jaén	Jaen		Spain
24	Hospital general de Jerez de la Frontera	Jerez de la Frontera		Spain
25	Hospital Juan Canalejo	La Coruña		Spain
26	Hospital Arnau de Vilanova	Lleida		Spain
27	Clínica La Concepción	Madrid		Spain
28	Clínica Puerta de Hierro	Madrid		Spain
29	Hospital Clínico San Carlos de Madrid	Madrid		Spain
30	Hospital de Fuenlabrada	Madrid		Spain
31	Hospital Doce de Octubre	Madrid		Spain
32	Hospital Gregorio Marañón	Madrid		Spain
33	Hospital Ramón y Cajal	Madrid		Spain
34	Hospital Universitario Princcipe de Asturias	Madrid		Spain
35	Hospital Universitario Morales Meseguer, Murcia	Murcia		Spain
36	. Hospital Clínico Universitario Virgen de la Victoria	Málaga		Spain
37	Hospital Carlos Haya	Málaga		Spain
38	Hospital comarcal de Valdeorras	O'Barco de Valdeorras		Spain
39	Hospital del Río Carrión	Palencia		Spain
40	Hospital Clínico Universitario de Salamanca	Salamanca		Spain
41	Hospital Universitario Marqués de Valdecilla	Santander		Spain
42	Hospital General	Segovia		Spain
43	Hospital Universitario Virgen del Rocío	Sevilla		Spain
44	Hospital Joan XXIII	Tarragona		Spain
45	Hospital Clínico Universitario	Valencia		Spain
46	Hospital dr. Peset	Valencia		Spain
47	Hospital General Universitario	Valencia		Spain
48	Hospital Universitario la Fe	Valencia		Spain
49	Hospital Meixoeiro	Vigo		Spain
50	Hospital Xeral	Vigo		Spain
51	Hospital Virgen de la Concha	Zamora		Spain