- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01063647
Dose-range Finding Treosulfan-based Conditioning
Allogeneic Hematopoietic Stem Cell Transplantation in Patients With Advanced Hematological Malignancies After Treosulfan-based Conditioning Therapy - A Clinical Phase II Study
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
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-
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Helsinki, Finland, FIN-00290
- Helsinki University Central Hospital
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-
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Berlin, Germany, 12203
- Charité University Hospital Berlin
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Hamburg, Germany, 20246
- University Hospital Hamburg Eppendorf
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Nuremberg, Germany, 90340
- 5th Medical Clinic, Clinic North
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Rostock, Germany, 18057
- University Hospital Rostock
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Katowice, Poland, 40-029
- Silesian Medical University
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Stockholm, Sweden, 141 86
- Karolinska University Hospital & Karolinska Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Patients with a haematological chemosensitive malignancy indicated for an allogeneic transplantation, but presenting an increased toxicity risk for classical (high-dose busulfan or standard-dose total body irradiation) conditioning therapies (remission criteria ref. to Appendix L):
- CML in first or subsequent chronic phase
- NHL in 2nd CR/PR, chemosensitive PR after autologous transplantation ; CLL in 2nd or subsequent CR/PR
- Relapsed Morbus Hodgkin (MH) after autologous transplantation
- Multiple Myeloma (MM) stage II and III according to Durie and Salmon
- AML in 2nd CR/PR or high-risk AML in 1st CR/PR
High-risk defined for example by the following:
- Cytogenetics: -5/5q, -7/7q, del(5q), abnormalities of 3q, complex karyotype (> 3 abnormalities), or
- PR after 1 cycle of induction therapy
- ALL in 2nd CR/PR or high-risk ALL in 1st CR/PR
High-risk defined as follows:
- Leukocytes > 3000/µl (B-Linage) or > 100000/µl (T-Linage);
- Pro-B-ALL, pre-T-ALL
- Cytogenetics: t(9;22)/BCR-ABL; t(4;11)/ALL1-AF
- MDS (patients without prior chemotherapy may be included)
Availability of an HLA-identical sibling donor (MRD) or HLA-identical unrelated donor (MUD) or one mismatch (out of the 6 standard markers) sibling donor (1 misMRD):
• HLA-identity defined by the following markers: A, B, DRB1. DQB1 must be recorded.
- Age > 18 years
- Karnofsky Index > 80 %
- Adequate contraception in female patients of child-bearing potential
- Co-operative behavior of individual patients
- Written informed consent
Exclusion Criteria:
- Completely chemotherapy-resistant disease
- Severe cardiac insufficiency, severe cardio-vascular or other severe concomitant diseases
- Symptomatic malignant involvement of the CNS
- Active infectious disease
- HIV-positive or active hepatitis infection
- Impaired liver function (Bilirubin > 1.5 x upper normal limit; Transaminases > 3.0 x upper normal limit)
- Impaired renal function (Creatinine-clearance < 60 ml/min; Serum Creatinine > 1.5 x upper normal limit).
- Pleural effusion or ascites > 1.0 L
- Pregnancy or lactation
- Known hypersensitivity to fludarabine and/or treosulfan
- Parallel participation in another experimental drug trial
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Treosulfan: 10 g/m² i.v. on 3 consecutive days (day -6 to -4)
|
10 g/m² i.v.
infusion, day -6, -5, -4
Other Names:
12 g/m² i.v.
infusion, day -6, -5, -4
Other Names:
14 g/m² i.v.
infusion, day -6, -5, -4
Other Names:
|
Experimental: 2
Treosulfan:12 g/m² i.v. on 3 consecutive days (day -6 to -4)
|
10 g/m² i.v.
infusion, day -6, -5, -4
Other Names:
12 g/m² i.v.
infusion, day -6, -5, -4
Other Names:
14 g/m² i.v.
infusion, day -6, -5, -4
Other Names:
|
Experimental: 3
Treosulfan: 14 g/m² i.v. on 3 consecutive days (day -6 to -4)
|
10 g/m² i.v.
infusion, day -6, -5, -4
Other Names:
12 g/m² i.v.
infusion, day -6, -5, -4
Other Names:
14 g/m² i.v.
infusion, day -6, -5, -4
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety - Evaluation of feasibility and tolerability of 3 x 10, 12 or 14 g/m² Treosulfan combined with 5 x 30 mg/m² fludarabine prior to allogeneic stem cell transplantation • frequency and severity of TRM until 6 months after transplantation
Time Frame: 6 months
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6 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Efficacy - Evaluation of the proportion of relapse- and/or progression free patients six months after transplantation (using standard remission criteria)
Time Frame: 6 months
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6 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mathias Freund, MD, University Hospital Rostock
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 (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Site
- Hematologic Diseases
- Neoplasms
- Hematologic Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Busulfan
- Treosulfan
Other Study ID Numbers
- MC-FludT.6/L
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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