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Leukemia, Lymphoblastic, AcutePhase 2LAL1104NCT00475280

"Geriatric Assessment Adapted" Therapy for Ph- ALL Elderly Patients

A Phase 2 study testing Geriatric assessment adapted therapy and Stem cells autotransplantation in people with Leukemia, Lymphoblastic, Acute, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 32 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study aims at considering clinical heterogeneity of patients based on a "geriatric assessment" without taking into account the real age of the subject. This will allow physicians to adapt therapy according to three different groups of patients: frail, fit and intermediate and to evaluate the efficacy and… Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Leukemia, Lymphoblastic, Acute
What is being tested?
Geriatric assessment adapted therapy and Stem cells autotransplantation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
102 participants
Where
32 sitesItaly
Study dates
Nov 2007to 28 Jan 2020
Phase
Phase 2
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

  • Age > 60 years old
  • Cytomorphologic and immunophenotypic diagnosis of ALL (all FAB groups except L3 and all immunophenotypes except SmIg+ B-ALL)
  • Signed informed consent

Who cannot join

  • Age <= 60 years old
  • Ph+ ALL
  • Refuse to sign informed consent

Trial locations and contacts

32 sites in 1 country.

32 sites in 1 country

Italy32 sites

  • Nuovo Ospedale "Torrete"

    Ancona

  • USL 8 - Ospedale S.Donato

    Arezzo

  • Az. Ospedaliera S. G. Moscati

    Avellino

  • Istituto di Ematologia "Lorenzo e A. Seragnoli" - Università degli Studi di Bologna - Policlinico S. Orsola - Malpighi

    Bologna

  • Ospedale Ferrarotto

    Catania

  • Azienda Ospedaliera Pugliese Ciaccio - Presidio Ospedaliero A.Pugliese - Unità Operativa di Ematologia

    Catanzaro

  • Marche U.O. di Medicina Interna - ASUR Marche 8 - Ospedale Civile

    Civitanova Marche

  • Azienda Ospedaliero Universitaria Arcispedale Sant'Anna Dipartimento di Scienze Mediche Sezione di Ematologia e Fisiopatologia dell'Emostasi

    Ferrara

  • Divisione Ematologia 1 - Azienda Ospedaliera Universitaria "San Martino"

    Genova

  • ASL Le/1 P.O. Vito Fazzi - U.O. di Ematologia ed UTIE

    Lecce

  • Azienda Ospedaliera Universitaria - Policlinico G. Martino Dipartimento di Medicina Interna - U.O. Messina

    Messina

  • Centro Oncologico Modenese - Dipartimento di Oncoematologia

    Modena

  • Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli"

    Naples

  • Azienda Ospedaliera Universitaria - Università Federico II

    Naples

  • Inferiore U.O. Medicina Interna Ematologia ed Oncologia P.O. Umberto I

    Nocera Inferiore

  • Dip. di Scienze Cliniche e Biologiche - Ospedale S. Luigi Gonzaga

    Orbassano

  • U.O. di Oncoematologia -plesso ospedaliero "A. Tortora" di Pagani

    Pagani, (SA)

  • La Maddalena Casa di Cura di Alta Specialità Dipartimento Oncologico di III Livello

    Palermo

  • Cattedra di Ematologia CTMO Università degli Studi di Parma

    Parma

  • Dipartimento Emato-Oncologia A.O."Bianchi-Melacrino-Morelli"

    Reggio Calabria

  • UO di Ematologia Centro Oncologico Basilicata

    Rionero in Vulture

  • Complesso Ospedaliero S. Giovanni Addolorata

    Roma

  • Divisione Ematologia - Università Campus Bio-Medico

    Roma

  • Segreteria di Ematologia - S.C. di Ematologia e Trapianti - I.F.O. Istituto Nazionale Tumori Regina Elena

    Roma

  • U.O.C. Ematologia - Ospedale S.Eugenio

    Roma

  • Università degli Studi "Sapienza" - Dip Biotecnologie Cellulari ed Ematologia - Divisione di Ematologia

    Roma

  • U.O. di Oncoematologia -plesso ospedaliero "A. Tortora" di Pagani

    Salerno

  • Istituto di Ematologia - IRCCS Ospedale Casa Sollievo della Sofferenza

    San Giovanni Rotondo

  • Serv. di Ematologia Ist. di Ematologia ed Endocrinologia

    Sassari

  • U.O.C. Ematologia e Trapianti - A.O. Senese - Policlinico " Le Scotte"

    Siena

  • Clinica Ematologica - Policlinico Universitario

    Udine

  • Università degli Studi di Verona - A. O. - Istituti Ospitalieri di Verona- Div. di Ematologia - Policlinico G.B. Rossi

    Verona

Other trials in Italy

About this study

Official title: "Geriatric Assessment Adapted" Therapy for Ph- ALL Elderly Patients. GIMEMA Protocol LAL1104. EudraCT Code 2005-002156-17

This study aims at considering clinical heterogeneity of patients based on a "geriatric assessment" without taking into account the real age of the subject. This will allow physicians to adapt therapy according to three different groups of patients: frail, fit and intermediate and to evaluate the efficacy and feasibility of a therapy adapted to the different categories of patients.

Read the detailed description

Treatment:

  1. Frail patients:
  • Pretreatment with PDN
  • Induction with Vinblastine and PDN
  • Maintenance with MTX, 6-MP, VBL and PDN
  1. Fit patients:
  • Pretreatment with PDN
  • Induction with VCR, DNR and PDN
  • Consolidation with MTX, ARA-C and G-CSF
  • Autologous transplantation
  • Maintenance with MTX, 6-MP, VCR, and PDN
  1. Intermediate patients:
  • Pretreatment with PDN
  • Induction with VCR, DNR and PDN
  • Consolidation with MTX, ARA-C and G-CSF
  • A second cycle of consolidation therapy
  • Maintenance with MTX, 6-MP, VCR, and PDN
Being tested
Geriatric assessment adapted therapy, Stem cells autotransplantation
Keywords
geriatric assessment adapted therapy, Leukemia, Lymphoblastic, Acute, Older patients, > 60 years old, Ph negative
Medical subject headings
Precursor Cell Lymphoblastic Leukemia-Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Geriatric assessment adapted therapyProcedure or surgery

    Geriatric assessment is performed before the induction phase starts.

  • Stem cells autotransplantationProcedure or surgery

    Stem cells autotransplantation is performed after consolidation treatment

Study groups in NCT00475280
Study groupRoleWhat they receive
Geriatric assessmentOtherNot described
Receives: Procedure: Geriatric assessment adapted therapy; Procedure: Stem cells autotransplantation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival in Ph negative ALL patients stratified according to a geriatric assessment

    Measured: at 6 months from diagnosis for the Frail group of pts and at 2 years from diagnosis for the Fit and Intermediate group of patients

Secondary outcomes (5)

  1. Complete Response rate

    Measured: After induction therapy

  2. Stem cell autotransplant feasibility

    Measured: At 6 months from diagnosis

  3. Incidence of adult ALL

    Measured: At diagnosis

  4. Evaluation of molecular, cytogenetics and immunophenotype heterogeneity in ph negative ALL patients >60

    Measured: At diagnosis and during follow-up

  5. Disease free survival

    Measured: During follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 May 2007 (estimated)
  2. Study startNov 2007
  3. Primary completionDec 2016
  4. Study completion28 Jan 2020

Resources

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
102 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00475280
Sponsor's protocol ID
LAL1104
Acronym
LAL1104
Status last verified
Oct 2022
First submitted
17 May 2007
Last updated
12 Oct 2022
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Sandler DP, Ross JA. Epidemiology of acute leukemia in children and adults. Semin Oncol. 1997 Feb;24(1):3-16.

    PubMed 9045302

  • Taylor PR, Reid MM, Bown N, Hamilton PJ, Proctor SJ. Acute lymphoblastic leukemia in patients aged 60 years and over: a population-based study of incidence and outcome. Blood. 1992 Oct 1;80(7):1813-7.

    PubMed 1382705

  • Taylor PR, Reid MM, Proctor SJ. Acute lymphoblastic leukaemia in the elderly. Leuk Lymphoma. 1994 May;13(5-6):373-80. doi: 10.3109/10428199409049625.

    PubMed 8069181

  • Kantarjian HM, O'Brien S, Smith T, Estey EH, Beran M, Preti A, Pierce S, Keating MJ. Acute lymphocytic leukaemia in the elderly: characteristics and outcome with the vincristine-adriamycin-dexamethasone (VAD) regimen. Br J Haematol. 1994 Sep;88(1):94-100. doi: 10.1111/j.1365-2141.1994.tb04982.x.

    PubMed 7803263

  • Delannoy A, Ferrant A, Bosly A, Chatelain C, Doyen C, Martiat P, Michaux JL, Sokal G. Acute lymphoblastic leukemia in the elderly. Eur J Haematol. 1990 Aug;45(2):90-3. doi: 10.1111/j.1600-0609.1990.tb00424.x.

    PubMed 2209825

  • Spath-Schwalbe E, Heil G, Heimpel H. Acute lymphoblastic leukemia in patients over 59 years of age. Experience in a single center over a 10-year period. Ann Hematol. 1994 Dec;69(6):291-6. doi: 10.1007/BF01696557.

    PubMed 7993936

  • Ferrari A, Annino L, Crescenzi S, Romani C, Mandelli F. Acute lymphoblastic leukemia in the elderly: results of two different treatment approaches in 49 patients during a 25-year period. Leukemia. 1995 Oct;9(10):1643-7.

    PubMed 7564503

  • Bassan R, Di Bona E, Lerede T, Pogliani E, Rossi G, D'Emilio A, Buelli M, Rambaldi A, Viero P, Rodeghiero F, Barbui T. Age-adapted moderate-dose induction and flexible outpatient postremission therapy for elderly patients with acute lymphoblastic leukemia. Leuk Lymphoma. 1996 Jul;22(3-4):295-301. doi: 10.3109/10428199609051761.

    PubMed 8819079

  • Delannoy A, Sebban C, Cony-Makhoul P, Cazin B, Cordonnier C, Bouabdallah R, Cahn JY, Dreyfus F, Sadoun A, Vernant JP, Gay C, Broustet A, Michaux JL, Fiere D. Age-adapted induction treatment of acute lymphoblastic leukemia in the elderly and assessment of maintenance with interferon combined with chemotherapy. A multicentric prospective study in forty patients. French Group for Treatment of Adult Acute Lymphoblastic Leukemia. Leukemia. 1997 Sep;11(9):1429-34. doi: 10.1038/sj.leu.2400780.

    PubMed 9305593

  • 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.

    PubMed 34048072

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Geriatric assessment adapted therapy and Stem cells autotransplantation in people with Leukemia, Lymphoblastic, Acute, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 32 sites in Italy.

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 3 inclusion and 3 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 12 Oct 2022. 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 Italy. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 in Ph negative ALL patients stratified according to a geriatric assessment (time frame: at 6 months from diagnosis for the Frail group of pts and at 2 years from diagnosis for the Fit and Intermediate group of patients). 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 NCT00475280, 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 12 Oct 2022.

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