Front-line Nilotinib Treatment of BCR-ABL+ Chronic Myeloid Leukaemia in Chronic Phase (CML0912)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01699217
Recruitment Status : Recruiting
First Posted : October 3, 2012
Last Update Posted : October 23, 2018
Information provided by (Responsible Party):
Gruppo Italiano Malattie EMatologiche dell'Adulto

Brief Summary:
The GIMEMA CML Working Party promotes a multicentre, observational, prospective study of CML patients treated frontline with NIL. Patients will be followed for 5 years. This study will help the definition of guidelines for the treatment of CML patients in early CP.

Condition or disease
Chronic Phase Philadelphia Positive BCR-ABL Positive Chronic Myeloid Leukaemia

Detailed Description:

The primary objective of the study is to describe the stability of molecular response with NIL as frontline therapy in newly diagnosed, unselected, CP CML patients, in an independent, investigator-initiated observational study. Imatinib mesylate (IM), a protein tyrosine kinase inhibitor (TKI) targeting BCR-ABL, has become in the last decade the standard of care for Chronic Myeloid Leukaemia (CML) in chronic phase (CP)1,2. Nilotinib (NIL) is a second generation TKI, effective in IM-resistant and IM-intolerant patients, which demonstrated superior efficacy to IM in early CP BCR-ABL+ CML patients3. Currently, the most important target of the treatment of CML with TKIs is the major molecular response (MMR), defined as a ≥ 3 log reduction in BCR-ABL/ABL transcript level, marker of better long-term outcome. With imatinib therapy, achieving a MMR correlates with an improved probability of a durable cytogenetic remission30. Results from IRIS suggest that a MMR after 12 months of imatinib therapy may be a marker of stable response. Further on, the IRIS study showed that patients with a MMR after 12 months of therapy had a significantly better probability of disease-free survival compared with those in complete cytogenetic remission, but not in MMR31. Moreover, obtaining an undetectable BCR-ABL transcript level is extremely relevant in order to consider TKIs discontinuation. This condition is known as "Complete Molecular Response" (CMR) and is further defined according to the sensitivity achieved (for the definition see the "Criteria of evaluation" section). As far as treatment discontinuation, two experiences have been published so far, aimed at evaluating the persistence of the CMR after imatinib discontinuation. The first was a pilot study32 where 12 patients were included. These 12 patients discontinued imatinib after at least 2 years of CMR (median duration of negativity, 32 months). Six patients displayed a molecular relapse with a detectable BCR-ABL transcript at 1, 1, 2, 3, 4, and 5 months. Imatinib was then reintroduced and led to a novel molecular response. Six other patients (50%) still have an undetectable level of BCR-ABL transcript after a median follow-up of 18 months (range, 9-24 months). The results of this pilot trial have been confirmed and extended in a second trial, the STIM trial33: 100 patients were enrolled, median follow-up 17 months, 69 patients with at least 12 months follow-up: 42 (61%) of these 69 patients relapsed (40 before 6 months, one patient at month 7, and one at month 19). At 12 months, the probability of persistent CMR for these 69 patients was 41% (95% CI 29-52). All patients who relapsed responded to reintroduction of imatinib. An increase of the CMR rate could possibly translate in a higher proportion of patients candidate to stopping anti-CML treatment, with higher probability of remaining disease-free in the long term. The advantages of this possible future scenario could be: first, the possibility of treatment discontinuation at least in patients with chronic clinical adverse events; second, a potential reduction of the costs of TKI treatment (after the introduction of TKI, the costs of CML treatment is increasing year by year, with the increasing prevalence of CML patients). Standardized molecular monitoring has become widely available in Europe through the efforts of EUTOS cooperation19 and now allows for the generation of comparable data on the residual disease using recalculation on the international scale despite these data being analyzed in many different laboratories. These advances in the standardization of molecular responses and the improvement of targeted therapy have allowed for comparable response assessment across Italian Centres and early treatment optimization of patients.

In summary, 1) monitoring of molecular response and of deep and sustained molecular response, provides a straightforward opportunity to assess patients' response and possible prognosis in the use of targeted therapy. 2) Most data on second generation TKIs are from company-sponsored studies generally implemented in selected referral centres. 3) The detailed description of the kinetic of the molecular response and, particularly, the rate of stable MR4, potentially related in turn with a subsequent treatment discontinuation, within the frame of a long-term post-marketing surveillance observational trial offered to all eligible patients followed at a nation-wide, independent multicentre group is the core distinctive feature of this observational trial.

Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Front-line Nilotinib Treatment of BCR-ABL+ Chronic Myeloid Leukaemia in Chronic Phase. An Observational Multicentre Study of the GIMEMA CML WP.
Actual Study Start Date : June 2013
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2019

Primary Outcome Measures :
  1. The rate of confirmed MR4 [ Time Frame: At 24 months from study entry ]

Secondary Outcome Measures :
  1. The rate of MMR [ Time Frame: At 24, 36, 48, and 60 months from study entry. ]
  2. The rate of MR4 [ Time Frame: At 24, 36, 48, and 60 months from study entry. ]
  3. The rate of MR4.5 [ Time Frame: At 24, 36, 48, and 60 months from study entry. ]
  4. The rate of confirmed MR4 [ Time Frame: At 36, 48, and 60 months from study entry. ]
  5. The rate of stable MR4 [ Time Frame: At 24, 36, 48, and 60 months from study entry ]
    (at least three PCR results with MR4 within the last year [± 2 months] and no results > 0.01% during the same period).

  6. The rate of stable MR4.5 [ Time Frame: At 24, 36, 48, and 60 months from study entry ]
    (at least three PCR results with MR4.5 within the last year [± 2 months] and no results > 0.0032% during the same period)

  7. The rate of confirmed loss of MMR (MR3) [ Time Frame: At 60 months from study entry ]
  8. The rate of confirmed loss of MMR [ Time Frame: At one year from study entry ]
  9. The rate of Complete Cytogenetic Response [ Time Frame: At one year. ]
  10. The cumulative rate of permanent NIL discontinuation [ Time Frame: At 5 years from study entry ]
    (for failure [defined according to ELN recommendations 2009], intolerance, and death for any reason; not for patients in ≥ MR4 entering clinical trials exploring nilotinib discontinuation)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Treatment decision is at the discretion of the investigator and must not be made on the basis of this observational study. Patients should have their treatment initiated in accordance with the summary of product characteristics.

Inclusion Criteria:

  • Age: >=18 years;
  • Patients with chronic phase Ph+ and/or BCR-ABL+ CML, newly diagnosed (less than 6 months);
  • Prior treatment with Hydroxyurea or Anagrelide is allowed;
  • Prior treatment with IM for less than 30 days is allowed;
  • Signed written informed const according to ICH/EU/GCP and national local laws.

Exclusion Criteria:

  • Patients who are pregnant (negative pregnancy test is requested within 2 days before nilotinib start) or breast feeding, or adults of reproductive potential not employing an effective method of birth control.
  • Newly diagnosed Ph+ and/or BCR-ABL+ CML patients in advanced phases (accelerated or blastic phase).
  • Prior treatment with nilotinib, dasatinib, or other tyrosine-kinase inhibitors.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01699217

Contact: Paola Fazi, Dr.
Contact: Enrico Crea

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Ivrea, Italy
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Latina, Italy
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Roma, Italy
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S. G. Rotondo, Italy
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Siena, Italy
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Terni, Italy
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Principal Investigator: Patrizia Pregno, Dr.         
Sezione di Ematologia - Med.II Div. Presidio Ospedaliero S. Chiara di Trento Not yet recruiting
Trento, Italy
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Principal Investigator: Paolo Vivaldi, Dr.         
Sub-Investigator: Anna Guella, Dr.         
Azienda U.L.S.S.9 - U.O. di Ematologia Recruiting
Treviso, Italy
Contact: Filippo Gherlinzoni, Dr.         
Principal Investigator: Filippo Gherlinzoni, Dr.         
Principal Investigator: Elisabetta Calistri, Dr.         
Clinica Ematologica - Policlinico Universitario Recruiting
Udine, Italy
Contact: Mario Tiribelli, Dr.         
Principal Investigator: Mario Tiribelli, Dr.         
Sub-Investigator: Luciana Marin, Dr.         
Università degli Studi di Verona - A. O. - Istituti Ospitalieri di Verona- Div. di Ematologia - Policlinico G.B. Rossi Not yet recruiting
Verona, Italy
Contact: Giovanni Pizzolo, Pr.         
Principal Investigator: Giovanni Pizzolo, Pr.         
Sub-Investigator: Massimiliano Bonifacio, Dr.         
Sponsors and Collaborators
Gruppo Italiano Malattie EMatologiche dell'Adulto
Principal Investigator: Gianantonio Rosti, Pr. Department of Hematology and Oncological Sciences, S.Orsola-Malpighi Hospital, University of Bologna

Responsible Party: Gruppo Italiano Malattie EMatologiche dell'Adulto Identifier: NCT01699217     History of Changes
Other Study ID Numbers: CML0912
First Posted: October 3, 2012    Key Record Dates
Last Update Posted: October 23, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Gruppo Italiano Malattie EMatologiche dell'Adulto:
Chronic Myeloid Leukaemia
Philadelphia positive
BCR-ABL positive

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases