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Alkylating agents

Tinostamustine for Blood Cancers

Phase 1
Waitlist Available
Led By Pier L Zinzani, MD,PhD
Research Sponsored by Mundipharma-EDO GmbH
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10-20 months after beginning stage 2
Awards & highlights

Study Summary

This trial will test a new drug, tinostamustine, on patients with cancer that has come back or didn't respond to other treatments. All patients will receive the drug.

Eligible Conditions
  • Multiple Myeloma
  • Hodgkin's Lymphoma
  • Cutaneous T-Cell Lymphoma
  • Blood Cancers

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10-20 months after beginning stage 2
This trial's timeline: 3 weeks for screening, Varies for treatment, and 10-20 months after beginning stage 2 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Clinical benefit rate by cohort
Overall response rate
Safety of selected doses in expanded population
Secondary outcome measures
Area Under Curve (AUC)
Duration of response
Maximum Plasma Concentration (Cmax)
+7 more
Other outcome measures
Sub study cardiac safety

Trial Design

1Treatment groups
Experimental Treatment
Group I: Tinostamustine (EDO-S101)Experimental Treatment1 Intervention
EDO-S101, IV, 20mg/m2 up to 150mg/m2 Day1 of each 21 day cycle-Stage 1; EDO-S101,IV, 40mg/m2 up to 60mg/m2 on Day 1 and Day 15 of 28 day cycle in multiple myeloma patients and IV, 40mg/m2 up to 100mg/m2 on Day 1 of 21 day cycle in lymphoma patients-Stage 2

Find a Location

Who is running the clinical trial?

Mundipharma-EDO GmbHLead Sponsor
4 Previous Clinical Trials
122 Total Patients Enrolled
1 Trials studying Multiple Myeloma
6 Patients Enrolled for Multiple Myeloma
Mundipharma Research LimitedLead Sponsor
37 Previous Clinical Trials
829,569 Total Patients Enrolled
Pier L Zinzani, MD,PhDPrincipal InvestigatorUniversity of Bologna Medical Center, Bologna

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Study of Tinostamustine, First-in-Class Alkylating HDACi Fusion Molecule, in Relapsed/Refractory Hematologic Malignancies
2016. "Study of Tinostamustine, First-in-Class Alkylating HDACi Fusion Molecule, in Relapsed/Refractory Hematologic Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02576496.
~12 spots leftby Apr 2025
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