STIM-FU: Follow-up of the Persistence of the Complete Molecular Remission After Stopping Imatinib Chronic Myeloid Leukemia

• Sponsor: University Hospital, Bordeaux (Other)
• Overall Status: Completed
• CT.gov ID: NCT02896829
• Collaborator: (none)
• Enrollment: 97
• Locations: 19
• Actual Duration (Months): 71.9
• Patients Per Site: 5.1
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

It's an observational study based on 98 patients included in the STIM trial to extend the monitoring of patients and to have molecular and clinical data, with long follow up. Are there late relapses? What has become patients who relapsed during STIM trial and restarted TKI (inhibitor tyrosine kinase) treatment?

Condition or Disease	Intervention/Treatment	Phase
Chronic Myeloid Leukemia	Behavioral: Interruption of the treatment by Imatinib

Detailed Description

Chronic myeloid leukemia (CML) is an hematopoietic stem cell disorder in which a t (9;22) (q34;q11) reciprocal chromosomal translocation gives rise to Philadelphia chromosome (Ph) and generates the BCR-ABL1 fusion gene encoding a constitutively activated protein tyrosine kinases (PTK). Tyrosine kinase Inibitors (TKIs) such as imatinib, by blocking BCR-ABL1 kinase activity, selectively eradicate CML cells and induce durable responses and prolong survival.

CML patients treated with TKI are monitored by BCR-ABL1 RT-qPCR (Reverse Transcription real-time quantitative Polymerase Chain Reaction) performed from peripheral blood samples.

A first multicenter study entitled STIM trial demonstrated that imatinib could be safely discontinued in patients with complete molecular remission (CMR) for at least 2 years (undetectable BCR-ABL1 transcript by RT-qPCR).

Around 40% of these patients remain in a prolonged treatment-free remission (TFR) after treatment cessation. All molecular relapsing patients were sensitive when imatinib was re-challenged.

The purpose of this STIM-FU study is to follow all the patients included in the STIM trial in order to evaluate their molecular status, vital status and ongoing treatment in patient with a first molecular relapse.

This long term follow up will allow us to predict if a constant long term control of the disease is possible and to better define the clinical and biological CML-related factors predictive for a molecular relapse after TKI discontinuation.

Study Design

• Study Type: Observational
• Actual Enrollment: 97 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: Follow-up of the Persistence of the Complete Molecular Remission After Stopping Imatinib Chronic Myeloid Leukemia
• Actual Study Start Date: Apr 3, 2013
• Actual Primary Completion Date: Apr 1, 2019
• Actual Study Completion Date: Apr 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Imatinib treatment ending Interruption of the treatment by Imatinib	Behavioral: Interruption of the treatment by Imatinib

Outcome Measures

Primary Outcome Measures

1. Assessment of the molecular status (BCR-ABL1 quantification by RT-qPCR) in the STIM1 population who stopped or restart a treatment by tyrosine kinase inhibitor (TKI) [up to five years]

Secondary Outcome Measures

1. Evaluation of rate of molecular relapse after imatinib discontinuation [up to five years]

2. Evaluation of duration of deep molecular response after stopping imatinib [up to five years]

3. Status dead or alive for each patient [up to five years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• The patients should have been included in the STIM1 Study CHUBX 2006/06 (NCT00478985)

Exclusion Criteria:

• The patients not included or discharged prematurely from the STIM1 Study can not participate to the study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU d'Angers	Angers		France	49033
2	Institut Bergonié	Bordeaux		France	33076
3	CHU de Bordeaux - Haut-Lévêque	Bordeaux		France	33604
4	Hôpital Morvan	Brest		France	29285
5	Hôpital Henri-Mondor	Creteil		France	94000
6	Pôle de cancérologie	Grenoble		France	38043
7	Centre Hospitalier de La Roche Sur Yon	La Roche Sur Yon		France	85025
8	Centre Hospitalier de Versailles	Le Chesnay		France	78157
9	Hôpital Claude Huriez	Lille		France	59037
10	Hôpital Edouard Herriot	Lyon		France	69374
11	Institut Paoli Calmette	Marseille		France	13273
12	CHU Hôtel-Dieu	Nantes		France	44035
13	CHU de Nice	Nice		France	06202
14	Hôpital Saint Louis	Paris		France	75475
15	Hôpital Necker-Enfants Malades	Paris		France	75743
16	CHU de Poitiers	Poitiers		France	86021
17	Hôpital Civil	Strasbourg		France	67000
18	Hôpital Purpan	Toulouse		France	31059
19	CHU Brabois	Vandoeuvre les Nancy		France	54500

Sponsors and Collaborators

• University Hospital, Bordeaux

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Bordeaux
• ClinicalTrials.gov Identifier: NCT02896829
• Other Study ID Numbers: CHUBX 2012/06
• First Posted: Sep 12, 2016
• Last Update Posted: Jun 19, 2020
• Last Verified: Jun 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Imatinib Mesylate

Study Results

No Results Posted as of Jun 19, 2020