FIL_BIOWM: Non-invasive Diagnostics and Monitoring of MRD and Clonal Evolution in Waldenström's Macroglobulinemia and in IgM-MGUS

Sponsor

Fondazione Italiana Linfomi ONLUS (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03521596

Collaborator

(none)

300

Enrollment

Locations

51.1

Anticipated Duration (Months)

21.4

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Condition or Disease	Intervention/Treatment	Phase
Waldenstrom Macroglobulinemia	Other: MRD and clonal evolution

Detailed Description

Multicenter retrospective and prospective observational study including patients with WM or IgM-MGUS evaluated at the time of diagnosis and during the disease course using highly sensitive techniques such as flow cytometry, real time quantitative PCR (RT-qPCR), digital droplet PCR (dd-PCR) and NGS, in order to: evaluate the mutational status on genomic DNA or cell-free DNA and compare the results to assess the most reliable source for mutation studies; perform and compare molecular and flow cytometry analyses on bone marrow, peripheral blood (both analyses), plasma and urine samples (only molecular analysis) to assess the best source for diagnosis and MRD monitoring.

Study Design

Study Type:

Observational

Actual Enrollment :

300 participants

Observational Model:

Cohort

Time Perspective:

Other

Official Title:

Non-invasive Diagnostics and Monitoring of Minimal Residual Disease and Clonal Evolution in Waldenström's Macroglobulinemia and in IgM Monoclonal Gammopathy of Undetermined Significance

Actual Study Start Date :

Aug 28, 2018

Actual Primary Completion Date :

Oct 6, 2020

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Patient enrolled Part of the patients will be retrospectively enrolled (learning sample) and part prospectively (validation sample)	Other: MRD and clonal evolution Patient evaluation at the time of diagnosis and during the disease course using highly sensitive techniques

Arm

Intervention/Treatment

Patient enrolled

Part of the patients will be retrospectively enrolled (learning sample) and part prospectively (validation sample)

Other: MRD and clonal evolution

Patient evaluation at the time of diagnosis and during the disease course using highly sensitive techniques

Outcome Measures

Primary Outcome Measures

Rate of mutation [22 months]
To demonstrate that the rate of mutations of MYD88 (L265P) and/or CXCR4 (S338X) detected in peripheral blood and/or urine show a negligible difference with the rate of mutations detected in bone marrow samples (BM, gold standard)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Diagnosis of IgM monoclonal gammopathy of undetermined significance (Ig-MGUS) or Waldenström's Macroglobulinemia (WM) according to criteria established at the second International Workshop on Waldenström's Macroglobulinemia [1]
Age ≥ 18 years
Previously untreated patients (only for the prospective cohort)
Symptomatic or asymptomatic disease
Subject understands and voluntarily signs an informed consent form approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB)

Exclusion Criteria:

Active HBV, HCV or HIV infection (antiHBc+ patients with undetectable HBV-DNA are eligible to the study)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Divisione di Ematologia Ospedale Niguarda	Milano	MI	Italy
2	SOS Ematologia Ospedale C. Massaia	Asti		Italy	14100
3	IRCCS Istituto Tumori Giovanni Paolo II - UOC Ematologia	Bari		Italy	70124
4	AOU Università degli Studi della Campania Luigi Vanvitelli	Napoli		Italy	80131
5	I.R.C.C.S. Istituto Oncologico Veneto - Oncologia 1	Padova		Italy	35128
6	A.O. Universitaria Di Parma	Parma		Italy	43126
7	Ematologia Policlinico San Matteo	Pavia		Italy	27100
8	AO Arcispedale Santa Maria Nuova - IRCCS	Reggio Emilia		Italy	42123
9	Ospedale degli Infermi di Rimini	Rimini		Italy	47924
10	Policlinico A. Gemelli Università Cattolica del Sacro Cuore	Roma		Italy	00168
11	UOC Ematologia, AOU Senese	Siena		Italy	53100
12	A.O. Città della Salute e della Scienza Ematologia Universitaria	Torino		Italy
13	Azienda Sanitaria Universitaria Integrata di Udine (A.S.U.I. Udine) - PO S. Maria della Misericordia	Udine		Italy	33100
14	Ematologia - OSPEDALE DI CIRCOLO E FONDAZIONE MACCHI	Varese		Italy	21100

Sponsors and Collaborators

Fondazione Italiana Linfomi ONLUS

Investigators

Principal Investigator: Marzia Varettoni, Pavia - IRCCS Policlinico S. Matteo di Pavia - Div. di Ematologia

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Fondazione Italiana Linfomi ONLUS

ClinicalTrials.gov Identifier:

NCT03521596

Other Study ID Numbers:

FIL_BIOWM

First Posted:

May 11, 2018

Last Update Posted:

Apr 25, 2022

Last Verified:

Apr 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Fondazione Italiana Linfomi ONLUS

IgM monoclonal gammopathy

Waldenström's Macroglobulinemia

Minimal residual disease

Clonal evolution

Additional relevant MeSH terms:

Waldenstrom Macroglobulinemia

Study Results

No Results Posted as of Apr 25, 2022