- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01111448
Temsirolimus in Myelodysplastic Syndrome (MDS) (TEMDS)
Treatment of MDS Patients With Single Agent Temsirolimus - a Pilot Study
Study Overview
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Chemnitz, Germany, 09113
- Klinikum Chemnitz Klinik für Innere Medizin III
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Dresden, Germany, 01307
- Universitätsklinikum C. G. Carus der TU Dresden
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Düsseldorf, Germany, 40225
- Universitätsklinikum Düsseldorf Klinik für Hämatologie, Onkologie und Klin. Immunologie
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Goettingen, Germany, 37075
- Universitätsmedizin Göttingen Georg-August-Universität Abteilung Hämatologie und Onkologie
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Leipzig, Germany, 04103
- Universitätsklinikum Leipzig AöR
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Leipzig, Germany, 04289
- Forschungsgesellschaft mbH
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Mannheim, Germany, 68167
- Klinikum Mannheim GmbH III. Medizinische Universitätsklinik -SP Hämatologie/Onkologie
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age >18 years at the time of signing the informed consent form;
- Patients able to understand the consequences of participating in this trial and not having any disorders or other circumstances (i.e. being in ward or imprisoned) which keeps them from giving written informed consent;
cytologically or histologically established diagnosis of de novo or therapy-related MDS according to the FAB-classification, either previously treated or untreated, presenting with:
- Group I (low-risk): Low- or INT-1 risk features according to IPSS and requiring at least 4 units of red blood cells within the last 8 weeks prior to screening visit or presenting with neutropenia (<1 Gpt/l neutrophils) or
- Group II (high-risk): INT-2 or HIGH-risk IPSS refractory or intolerant to 5-Azacytidine.
CMML patients of dysplastic phenotype (WBC < 13 Gpt/l) may be included in both arms according to IPSS. CMML patients showing proliferative phenotype (WBC >=13 Gpt/l) will be included in the high risk arm;
- not eligible for an immediate allogeneic HSCT or conventional chemotherapy;
- all previous MDS specific therapies (except supportive approaches like transfusions or antibiotics) must have been discontinued at least 4 weeks prior to study enrollment;
- ECOG performance status of <= 3 at study entry;
laboratory test results within these ranges:
- Serum creatinine <= 177 µmo/l (<= 2.0 mg/dL);
- total bilirubin <= 3 x ULN;
- AST (SGOT) and ALT (SGPT) <= 3 x ULN;
- total fasting cholesterol <= 9.1 mmol/l (350 mg/dl);
- fasting triglyceride level <= 4.5 mmol/l (400 mg/dl);
- platelets > 25 Gpt/l without transfusion support in patients with LOW- and INT-1 Risk according to IPSS;
- signed informed consent.
Exclusion Criteria:
- For Patients with LOW- or INT1-Risk according to IPSS: Thrombocytopenia below 25 Gpt/l (INT2- and HIGH-IPSS patients may be included irrespective of platelet count);
- known hypersensitivity to temsirolimus, sirolimus or any components of the infusion solution (dl-alpha-tocopherol, propylene glycol, anhydrous citric acid, polysorbate 80, polyethylene glycol 400, dehydrated alcohol);
- known hypersensitivity to macrolid antibiotics (because of structural similarities between this class of antibiotics and study medication);
- any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study;
- known positive for HIV or any other uncontrolled infection;
- presence of any other malignancy being not in complete remission for at least 3 years (previous chemotherapy for other malignancies is not an exclusion criteria);
- necessity of therapeutic anticoagulation (excluding low dose ASS);
- participation in an other clinical trial within the last 4 weeks;
- pregnant or breast feeding females (lactating females must agree not to breast feed while on study);
females of childbearing potential (FCBP) except those fulfilling at least one of the following criteria:
- post-menopausal (12 months of natural amenorrhea or 6 months of amenorrhea with serum FSH > 40 U/ml);
- post-surgery (6 weeks after bilateral ovarectomy with or without hysterectomy);regular and correct use of contraceptives with a PEARL Index of < 1% (e.g. implants, depot formulations of hormones, oral contraceptives, intra uterine device - IUD);
- sexual abstinence;
- partner, who had vasectomy (confirmed by two negative analyses of semen);
- male patients, who do not agree to use a latex condom during sexual contact with females of childbearing potential while participating in the study and for at least 3 months following discontinuation from the study even if he has undergone a successful vasectomy;
- patients with a history of chronic drug abuse or another illness which does not allow the patient to assess the nature and/or possible consequences of the study;
- patients who are not likely to follow the trial protocol (lack of willingness to cooperate).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: Temsirolimus
25 mg/day 1; 8; 15; 22 of each 28-day cycle
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25 mg/day 1; 8; 15; 22 of each 28-day cycle as intravenous infusion over 30 min
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall hematological response rate using modified IWG criteria (combination of CR, PR, marrow-CR and SD with HI).
Time Frame: at 4 months
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at 4 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall survival
Time Frame: 1 year
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1 year
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Progression-free-survival
Time Frame: 1 year
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1 year
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Toxicity as measured by NCI CTCAE v3.0
Time Frame: 4 and 12 months
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4 and 12 months
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Rate of leukemic progression
Time Frame: 1 year
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1 year
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Overall hematological response rate using modified IWG-criteria
Time Frame: 1 year
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1 year
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Quality of life as measured by EORTC-QLQ30
Time Frame: 4 months, 12 months
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4 months, 12 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Uwe Platzbecker, MD, PhD, Medizinische Klinik I, Universitätsklinikum Carl-Gustav-Carus, Dresden, Germany
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms
- Disease
- Bone Marrow Diseases
- Hematologic Diseases
- Precancerous Conditions
- Syndrome
- Myelodysplastic Syndromes
- Preleukemia
- Physiological Effects of Drugs
- Anti-Infective Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Anti-Bacterial Agents
- Antibiotics, Antineoplastic
- Antifungal Agents
- Sirolimus
Other Study ID Numbers
- TUD-TEMDS1-042
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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