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| ID | Type | Description | Link |
|---|---|---|---|
| LAL0904 | Other Identifier | GIMEMA | |
| 2004-001738-11 | Other Identifier | EudraCT |
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RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. A peripheral stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy. When the healthy stem cells are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Giving combination chemotherapy together with imatinib mesylate and peripheral stem cell transplant may be an effective treatment for acute lymphoblastic leukemia.
Nevertheless, in the last few years GIMEMA has pubblished a paper in which 100% of Ph+ ALL patients reach HCR only with Imatinib, without any chemiotherapy. Thus, this treatment will be implemented in patients pertaining to this category.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| asparaginase | Drug | |||
| daunorubicin hydrochloride | Drug | |||
| etoposide | Drug | |||
| idarubicin | Drug | |||
| imatinib mesylate | Drug | |||
| mercaptopurine | Drug | |||
| methotrexate | Drug | |||
| methylprednisolone |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Reaching Disease Free Survival | At 60 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Reaching Complete Hematological Response After Induction Therapy | At the end of induction, day +50 | |
| Percentage of Participants Reaching Overall Survival | Overall survival from diagnosis |
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DISEASE CHARACTERISTICS:
Diagnosis of acute lymphoblastic leukemia (ALL) meeting the following criteria:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Roberto Foa, MD | Universita Degli Studi "La Sapeinza" | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale Civile Alessandria | Alessandria | I-15100 | Italy | |||
| Ospedale Torrette University Ancona |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27515250 | Background | Chiaretti S, Vitale A, Vignetti M, Piciocchi A, Fazi P, Elia L, Falini B, Ronco F, Ferrara F, De Fabritiis P, Luppi M, La Nasa G, Tedeschi A, Califano C, Fanin R, Dore F, Mandelli F, Meloni G, Foa R. A sequential approach with imatinib, chemotherapy and transplant for adult Ph+ acute lymphoblastic leukemia: final results of the GIMEMA LAL 0904 study. Haematologica. 2016 Dec;101(12):1544-1552. doi: 10.3324/haematol.2016.144535. Epub 2016 Aug 11. | |
| 21623761 |
| Label | URL |
|---|---|
| GIMEMA Foundation Website | View source |
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We are reporting on the subset of patients that was treated according to amendment three, in which Imatinib was given only at induction.
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| ID | Title | Description |
|---|---|---|
| FG000 | Philadelphia Positive, Imatinib Only in Induction Therapy | These subset of patients was treated according to amendment three, in which Imatinib was given only at induction. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
| mitoxantrone hydrochloride | Drug |
| prednisone | Drug |
| vincristine sulfate | Drug |
| allogeneic hematopoietic stem cell transplantation | Procedure |
| autologous hematopoietic stem cell transplantation | Procedure |
| peripheral blood stem cell transplantation | Procedure |
| radiation therapy | Radiation |
| At 60 months |
| Ancona |
| 60020 |
| Italy |
| Ospedale S. Donato | Arezzo | 52100 | Italy |
| Dipartimento Area Medica - Presidio Ospedaliero "C. e G.Mazzoni" | Ascoli Piceno | Italy |
| S.G. Moscati Hospital | Avellino | 83100 | Italy |
| Universita Degli Studi di Bari | Bari | 70124 | Italy |
| University of Bologna Medical School | Bologna | 40138 | Italy |
| Spedali Civili di Brescia | Brescia | 25123 | Italy |
| A. Perrino Hospital | Brindisi | 72100 | Italy |
| Ospedale Binaghi | Cagliari | 090100 | Italy |
| Ospedale Ferrarotto | Catania | 95124 | Italy |
| Ospedale Regionale A. Pugliese | Catanzaro | 88100 | Italy |
| U.O. Ematologia - P.O. Annunziata - A.O. di Cosenza | Cosenza | Italy |
| Universita di Ferrara | Ferrara | 44100 | Italy |
| Azienda Ospedaliera di Firenze | Florence | 50011 | Italy |
| Ospedali Riuniti Foggia | Foggia | 71100 | Italy |
| Ospedale Umberto I | Frosinone | 03100 | Italy |
| Ospedale S. Antonio Abate | Gallarate | 21013 | Italy |
| Ospedale San Martino | Genoa | 16132 | Italy |
| Ospedale Santa Maria Goretti | Latina | 04100 | Italy |
| Le/1 P.O. Vito Fazzi - U.O. di Ematologia ed UTIE | Lecce | Italy |
| Ospedale Maggiore Lodi | Lodi | I-20075 | Italy |
| Ospedale L'Aquila | L’Aquila | 67100 | Italy |
| Azienda Ospedaliera Universitaria - Policlinico G. Martino | Messina | 98125 | Italy |
| Ospedale Niguarda Ca'Granda | Milan | 20162 | Italy |
| Azienda Ospedaliera - Universitaria di Modena | Modena | 41100 | Italy |
| Azienda Ospedaliera di Rilievo Nazionale A.Cardarelli | Naples | 80127 | Italy |
| Federico II University Medical School | Naples | 80131 | Italy |
| Ospedale S. Gennaro ASL NA1 | Naples | 80131 | Italy |
| Inferiore U.O. Medicina Interna Ematologia ed Oncologia P.O. Umberto I | Nocera Inferiore | Italy |
| Amedeo Avogadro University of Eastern Piedmont | Novara | I-28100 | Italy |
| Ospedale San Francesco | Nuoro | 08100 | Italy |
| Azienda Ospedale S. Luigi at University of Torino | Orbassano | 10043 | Italy |
| Azienda Ospedaliera di Padova | Padova | 35128 | Italy |
| Policlinico - Cattedra di Ematologia | Palermo | 90100 | Italy |
| Ospedale Cervello | Palermo | 90146 | Italy |
| Ospedale La Maddalena - Palermo | Palermo | Italy |
| Fondazione I.R.C.C.S. Policlinico San Matteo | Pavia | 27100 | Italy |
| University of Pavia | Pavia | 27100 | Italy |
| Perugia Regional Cancer Center | Perugia | 06122 | Italy |
| Azienda Ospedale - d S. Salvatore | Pesaro | 61100 | Italy |
| Ospedale Civile Pescara | Pescara | 65100 | Italy |
| Azienda Ospedaliera Pisana | Pisa | Italy |
| Azienda Ospedaliera San Carlo - Potenza | Potenza | 85100 | Italy |
| Ospedale Sta. Maria Delle Croci | Ravenna | 48100 | Italy |
| Ospedale S. M. delle Croci | Ravenna | I-48100 | Italy |
| Azienda Ospedaliera Bianchi Melacrino Morelli | Reggio Calabria | 89100 | Italy |
| Arcispedale S. Maria Nuova | Reggio Emilia | 42100 | Italy |
| Ospedale Oncologico Regionale | Rionero in Vulture | I-58028 | Italy |
| Ospedale Sant' Eugenio | Rome | 00144 | Italy |
| Azienda Ospedaliera S. Camillo-Forlanini | Rome | 00151 | Italy |
| University Campus Bio-Medico | Rome | 00155 | Italy |
| Istituto Regina Elena | Rome | 00161 | Italy |
| Universita Degli Studi "La Sapeinza" | Rome | 00161 | Italy |
| Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore | Rome | 00168 | Italy |
| H. San Giovanni-Addolorata Hospital | Rome | 00184 | Italy |
| Ospedale di Ronciglione | Ronciglione | 01037 | Italy |
| IRCCS "Casa Sollievo della Sofferenza" | San Giovanni Rotondo | 71013 | Italy |
| Istituto di Ematologia Universita - University di Sassari | Sassari | 07100 | Italy |
| Azienda Ospedale E. Morelli | Sondalo | 23039 | Italy |
| Ospedale S. Vincenzo | Taormina | 98039 | Italy |
| Ospedal SS Annunziata | Taranto | 74100 | Italy |
| Azienda Sanitaria Ospedale San Giovanni Battista Molinette di Torino | Turin | 10126 | Italy |
| Ospedale Giovanni Bosco | Turin | Italy |
| Policlinico Universitario Udine | Udine | 33100 | Italy |
| Università degli Studi di Verona - A. O. - Istituti Ospitalieri di Verona- Div. di Ematologia - Policlinico G.B. Rossi | Verona | Italy |
| Result |
| Messina M, Chiaretti S, Iacobucci I, Tavolaro S, Lonetti A, Santangelo S, Elia L, Papayannidis C, Paoloni F, Vitale A, Guarini A, Martinelli G, Foa R. AICDA expression in BCR/ABL1-positive acute lymphoblastic leukaemia is associated with a peculiar gene expression profile. Br J Haematol. 2011 Mar;152(6):727-32. doi: 10.1111/j.1365-2141.2010.08449.x. Epub 2011 Jan 31. |
| 34048072 | Derived | Piciocchi A, Messina M, Elia L, Vitale A, Soddu S, Testi AM, Chiaretti S, Mancini M, Albano F, Spadano A, Krampera M, Bonifacio M, Cairoli R, Vetro C, Colella F, Ferrara F, Cimino G, Bassan R, Fazi P, Vignetti M. Prognostic impact of KMT2A-AFF1-positivity in 926 BCR-ABL1-negative B-lineage acute lymphoblastic leukemia patients treated in GIMEMA clinical trials since 1996. Am J Hematol. 2021 Sep 1;96(9):E334-E338. doi: 10.1002/ajh.26253. Epub 2021 Jun 9. No abstract available. |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Philadelphia Positive, Imatinib Only in Induction Therapy | In this protocol, adult Philadelphia positive acute lymphoblastic leukemia patients were treated with chemotherapy for induction and consolidation, followed by maintenance with imatinib. The protocol was subsequently amended and imatinib was incorporated in the induction and post-remission phase together with chemotherapy. Due to the toxicity of this combined approach, the protocol was further amended to a sequential scheme based on imatinib plus steroids as induction, followed by consolidation with chemotherapy plus imatinib and, when applicable, by a hematopoietic stem cell transplant. Thus, we have analyzed only this subset of patients as it was not feasible to analyzed all patients enrolled due also to the disease itself. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| White Blood Cells (WBC) at diagnosis-nsr | Median | Full Range | 10^9 cells/L |
| |||||||||||||||||
| BCR transcript-molecular at diagnosis | Number | participants |
| ||||||||||||||||||
| Pre-treatment response | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Reaching Disease Free Survival | Posted | Number | percentage of participants | At 60 months |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Number of Patients Reaching Complete Hematological Response After Induction Therapy | Posted | Number | participants | At the end of induction, day +50 |
|
| |||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Reaching Overall Survival | Overall survival from diagnosis | Posted | Number | percentage of patients | At 60 months |
|
|
34 months
Only serious adverse events are reported.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Philadelphia Positive, Imatinib Only in Induction Therapy | In this protocol, adult Philadelphia positive acute lymphoblastic leukemia patients were treated with chemotherapy for induction and consolidation, followed by maintenance with imatinib. The protocol was subsequently amended and imatinib was incorporated in the induction and post-remission phase together with chemotherapy. Due to the toxicity of this combined approach, the protocol was further amended to a sequential scheme based on imatinib plus steroids as induction, followed by consolidation with chemotherapy plus imatinib and, when applicable, by a hematopoietic stem cell transplant. Thus, we have analyzed only this subset of patients as it was not feasible to analyzed all patients enrolled due also to the disease itself. | 2 | 51 | 7 | 51 | 0 | 51 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders | Non-systematic Assessment |
| ||
| Headache | Nervous system disorders | Non-systematic Assessment |
| ||
| Pyrexia | General disorders | Non-systematic Assessment |
| ||
| Hypoxia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Intra-abdominal haematoma | Vascular disorders | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alfonso Piciocchi | GIMEMA | +39 06 70390513 | a.piciocchi@gimema.it |
| ID | Term |
|---|---|
| D007938 | Leukemia |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007945 | Leukemia, Lymphoid |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D001215 | Asparaginase |
| D003630 | Daunorubicin |
| D005047 | Etoposide |
| D015255 | Idarubicin |
| D000068877 | Imatinib Mesylate |
| D015122 | Mercaptopurine |
| D008727 | Methotrexate |
| D008775 | Methylprednisolone |
| D008942 | Mitoxantrone |
| D011241 | Prednisone |
| D014750 | Vincristine |
| D036102 | Peripheral Blood Stem Cell Transplantation |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D000581 | Amidohydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D005960 | Glucosides |
| D001549 | Benzamides |
| D000577 | Amides |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |
| D013438 | Sulfhydryl Compounds |
| D013457 | Sulfur Compounds |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D000880 | Anthraquinones |
| D000095322 | Anthrones |
| D000873 | Anthracenes |
| D011809 | Quinones |
| D011244 | Pregnadienediols |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D007211 | Indoles |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D018380 | Hematopoietic Stem Cell Transplantation |
| D033581 | Stem Cell Transplantation |
| D017690 | Cell Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |
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| p190/p210 |
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| Frequency missing |
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