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Clinical picture: NHL (Non Hodgkin Lymphoma)

Trial: HOVON 124 WM


News
1. Overview
2. Patient eligibility criteria
3. Registration (& randomization) of patients
4. Participating parties
5. Participating sites
6. Instruction videos
7. Download documentation / forms


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News


HOVON 124 WM open for patient inclusion phase II

After review of the data provided, the DSMB, validated that the safety profile of the phase 1 portion of this study trial of Ixazomib-Rituximab-and Dexamethasone in RRWM appeared safe and manageable. They had no remark, concern or have seen limitation to the recommendation of the study to pursue to phase 2 with the dose of Ixazomib 4mg/w, d1, 8, 15; -Rituximab-and Dexamethasone as per protocol level 1.

1. Overview



Summary

A prospective phase I/II trial of the combination of ixazomib citrate, rituximab and dexamethasone in patients with relapsed Waldenström's macroglobulinemia.


Status

open


Members

HOVON in association with Greek Myeloma Study Group



Type of study

Prospective Phase I/II study


Echelon level

Limited site selection


Type of monitoring for this study

Site evaluation visits


Target number of patients

66


Current number of patients

30


Approved by

cEC AMC
CA CCMO


Study objectives

Phase I part: establish maximum tolerated dose for the combination of ixazomib citrate and dexamethasone

Phase II part: assess the efficacy of oral ixazomib citrate in combination with rituximab and dexamethasone


2. Patient eligibility criteria



Inclusion criteria

• A diagnosis of WM (lymphoplasmacytoid lymphoma in the bone marrow with an IgM M-protein)
• Age ≥ 18 years
• WHO 0-2
•Presence of an IgM M-protein in the serum (as demonstrated by SPEP and IF)
• Measurable disease (IgM M-protein > 10 g/l (1 g/dl or, in case the M-protein is present but unquantifiable, total serum IgM level > 10 g/l (1 g/dl))
• Symptomatic disease
• ≥ 1 prior lines of treatment
• Patients showing progressive disease under treatment with chemotherapy only (e.g. chlorambucil, CVP, fludarabine or fludarabine/cyclophosphamide) are allowed on study
•Platelets > 75x109/l. Platelet transfusions to help patients meet eligibility criteria are not allowed within 3 days before study enrollment.
•ANC >1.0 x109/l
•Negative pregnancy test at study entry for women of childbearing potential
•A female patient is either post-menopausal for at least 1 year before the screening visit, or surgically sterile, or, if of childbearing potential, agrees to practice 2 effective methods of contraception at the same time, from the time of signing the informed consent until 12 months after the last dose of rituximab, or agrees to completely abstain from heterosexual intercourse. Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception)
•Male patients, even if surgically sterilized, (i.e., status post vasectomy) must agree to practice effective barrier contraception during the entire study period and through 90 days after the last dose of ixazomib and/or rituximab, or agree to completely abstain from heterosexual intercourse. Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception)
•Written informed consent
•Prior plasmapheresis in case of symptomatic hyperviscosity is allowed


Exclusion criteria

• Bortezomib refractory (no PR/CR after treatment with bortezomib, and/or progression within 6 months of treatment with bortezomib)
• Rituximab refractory (progressive disease during treatment or within 6 months after last administration of rituximab)
• WHO performance status >2
• Amyloidosis
• Peripheral neuropathy, grade 3 or higher
• Creatinine clearance <30 ml/min
• Known HIV seropositivity
• Patients with active hepatitis B or C infection
• Known intolerance of rituximab and/or boron
• Bing Neel syndrome or other severe neurological disorders
• Severe cardiac dysfunction (NYHA classification III-IV; see appendix….)
• Severe pulmonary dysfunction (CTCAE grade III-IV, see appendix …)
• Significant hepatic dysfunction (defined as total bilirubin >1.5 ULN (unless caused by Gilbert syndrome) and/or transaminases ≥3 times upper limit of normal, unless caused by WM
• Active, uncontrolled infections
• Concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes, hypertension, cancer)
• A history of other malignancies, unless the malignancy has been in remission for at least 5 years (with the exception of basal carcinoma of the skin or stage 0 cervical carcinoma)
• Pregnancy or breastfeeding
• Current participation in another clinical trial
• Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule


3. Registration (& randomization) of patients



Registration

Central registration at the HOVON Data Center:
Erasmus MC - Clinical Trial Center
P.O box 2040
3000 CA Rotterdam
Phone number: +31.10.704.1560 (working days 9.00-17.00)
Fax number: +31.10.704.1028


4. Participating parties



Principal Investigator(s)

Mw. M.J. Kersten (AMC)


Co-Investigator(s)

Mw. Dr. M.C. Minnema (UMCU)
Dr. J.M.I. Vos (Antonius Ziekenhuis)


Coordinating Investigator(s)

Dr. M.A. Dimopoulos (Regional General Hospital Alexandra)
Mw. dr. A.M.H. Janssens (UZ Gasthuisberg)


Statistician(s)

Dhr. K. Nasserinejad (Erasmus MC - Centrum)


Monitor - Site Evaluation Visits

Mw. W.M Keller (Erasmus MC - Daniel)
Mw. T. van de Klundert (Erasmus MC - Daniel)


Monitor - Study Specific

A. Tsonis (Health Data Specialists Ltd.)


Other functions

Central Coordinator - Special Investigations - Mw. M. Spiering (AMC)
Central Coordinator - Special Investigations - Trialbureau Hematologie AMC (AMC)
Central Pharmacist - Mw. J.K. Berbee (AMC)
Reviewer - Pathology - Prof. Dr. S.T. Pals (AMC)


Trial manager

M. Kap (m.kap.1@erasmusmc.nl)


5. Participating sites



Site
Included patients *
BE-Antwerpen-ZNA Stuivenberg
1
BE-Gent-UZ Gent
3
BE-Leuven-UZ Gasthuisberg
0
BE-Roeselare-AZDelta
3
BE-Turnhout-AZ Turnhout Campus St. Elisabeth
0
GR-Athens-Regional General Hospital Alexandra
6
NL-Amsterdam-AMC
2
NL-Amsterdam-VUMC
3
NL-Capelle a/d IJssel-IJsselland Ziekenhuis
0
NL-Den Haag-Hagaziekenhuis, locatie Leyweg
1
Show 11 more...
* Please note that if TOP is not used to register patients for a study, the number of patients shown is zero.

6. Instruction videos



7. Download documentation / forms


 Protocol



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