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APG101 in Myelodysplastic Syndrome

NCT01736436 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2016-08-24

No results posted yet for this study

Summary

It has been shown in preclinical experiments with bone marrow from patients with myelodysplastic syndrome that APG101 rescues erythrocytes from premature cell death. This is expected to translate in an improved erythropoiesis and ameliorated anemia in MDS patients.

APG101 might, therefore, be a valuable addition to current treatments of low- or intermediate MDS patients suffering from anaemia.

Transfusion-dependent patients with low or intermediate risk MDS according to WHO Prognostic Scoring Scale (WPSS) can be included in this study.

Treatment consists of 100mg APG101 intravenous as a weekly treatment over 12 weeks + 6 months follow up phase.

Primary objective of the trial is safety and tolerability of APG101; secondary objectives are

* Hematologic, cytologic and cytogenetic response rate using modified International Working Group (IWG) response criteria
* Incidence and time to leukemic progression at 37 weeks
* OS (Overall survival) at 37 weeks

Conditions

Interventions

DRUG

Treatment with APG101

Patients will be treated 12 weeks with 100 mg APG101 intravenous weekly

PROCEDURE

Bone marrow collection

During the study, bone marrow will be collected 4 times to assess study objectives

PROCEDURE

Blood drawings

During the study, blood will be drawn at different time points to assess study objectives

Sponsors & Collaborators

  • Apogenix GmbH

    lead INDUSTRY

Principal Investigators

  • Florian Nolte, MD · Universitaetsmedizin Mannheim, III. Medizinische Klinik, Hämatologie und Onkologie, Theodor-Kutzer-Ufer 1-3, 68167 Mannheim, Germany

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01736436 on ClinicalTrials.gov