Sequential Analysis in Patients With an Hemopathy (S-HEMO)

Recent advances in hematology clearly illustrate that the simple "clonal" nature of various hematological malignancies may not really reflect the reality of malignant cells natural expansion. This has been nicely illustrated in recent works in AML for example where subclones coexists in the same patient at the same time, but could also differentially expand over time because of effects of therapeutics intervention, but also by oncogenic spontaneous events (1).

These observations have been done recently because of next generation sequencing that allows to discriminate in the same tumor samples, different subclones and to analyse the clonal architecture. Sequential analyses could help us to identify the first oncogenic event and to correlate disease progression to the emergence of subclones.

For all these reasons it is of a major interest to precisely understand the architecture of the clone in MPNs, especially to understand which is the initiating event and how from this initial event the clone develops.

In MPNs in which JAK2V617F is the initiating event, its targeting is expected to be extremely effective. If JAK2V617F is a secondary event its targeting might allow to alleviate the MPN, but may favor the development of other malignant hemopathies.

Study Overview

• Status: Recruiting
• Conditions: Hemopathy
• Intervention / Treatment: Other: Blood samples

• Study Type: Interventional
• Enrollment (Anticipated): 246
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Vincent RIBRAG, MD; Phone Number: +33 0142114507; Email: vincent.ribrag@gustaveroussy.fr
• Study Contact Backup: Name: Thibaud MOTREFF, MD; Phone Number: +33 0142116643; Email: thibaud.motreff@gustaveroussy.fr

Study Locations

• France
  • Val de Marne
    • Villejuif, Val de Marne, France, 94805
      • Recruiting
      • Gustave Roussy
      • Contact: Vincent RIBRAG, MD; Phone Number: +33 0142114507; Email: vincent.ribrag@gustaveroussy.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with a malignant hematological disease.
• Signed written informed consent
• Age and Sex : men and women aged 18 years or older
• Patients affiliated to a social security system

Exclusion Criteria:

- Patients protected by law, in accordance with Articles L1121-L1121-5 to 8 of the Code of Public Health.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: chronic myelomonocytic leukemia; Three cohorts will be investigated: ET (essential thrombocythemia), IMF and secondary MF (myelofibrosis) and CMML (chronic myelomonocytic leukemia)	Other: Blood samples
Other: essential thrombocytemia; Three cohorts will be investigated: ET (essential thrombocythemia), IMF and secondary MF (myelofibrosis) and CMML (chronic myelomonocytic leukemia)	Other: Blood samples
Other: myelofibrosis; Three cohorts will be investigated: ET (essential thrombocythemia), IMF and secondary MF (myelofibrosis) and CMML (chronic myelomonocytic leukemia)	Other: Blood samples

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identification of new genetic alterations	Identification of new genetic alterations in patients with hematological malignancies by next generation sequencing using blood samples	At baseline and then every 6 months up to 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sequential analysis of the malignant clones	Sequential analysis of the malignant clones for each patient included in the trial using genetic markers	At baseline and 12 months after inclusion

Collaborators and Investigators

• Sponsor: Gustave Roussy, Cancer Campus, Grand Paris
• Investigators: Study Chair: Vincent RIBRAG, MD, Gustave Roussy, Cancer Campus, Grand Paris

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Anticipated): January 1, 2019
• Study Completion (Anticipated): January 1, 2026

Study Registration Dates

• First Submitted: September 16, 2014
• First Submitted That Met QC Criteria: October 6, 2014
• First Posted (Estimate): October 9, 2014

Study Record Updates

• Last Update Posted (Actual): August 8, 2017
• Last Update Submitted That Met QC Criteria: August 7, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 2013-A00208-37; 2013/2031 (Other Identifier: CSET number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No