Dose-range Finding Treosulfan-based Conditioning

NCT01063647 | Completed Phase 1 DMC

• 1 other identifier: MC-FludT.6/L
• Study Type: interventional
• Target: 56
• Locations: 4 countries
• Sites: 7

Brief Summary

Evaluation of the safety and efficacy of 3 x 10, 3 x 12 or 3 x 14 g/m² Treosulfan resp., combined with 5 x 30 mg/m² fludarabine prior to allogeneic, hematopoietic stem cell transplantation of patients with hematological malignancies, but non-eligible to standard conditioning treatment.

Conditions

Hematological Malignancies

Keywords

Treosulfan; Allogeneic stem cell transplantation; Conditioning therapy

Outcome Measures

Primary Outcomes (1)

• 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

  6 months

Secondary Outcomes (1)

• Efficacy - Evaluation of the proportion of relapse- and/or progression free patients six months after transplantation (using standard remission criteria)

  6 months

Study Arms (3)

1

EXPERIMENTAL

Treosulfan: 10 g/m² i.v. on 3 consecutive days (day -6 to -4)

Drug: Treosulfan

2

EXPERIMENTAL

Treosulfan:12 g/m² i.v. on 3 consecutive days (day -6 to -4)

Drug: Treosulfan

3

EXPERIMENTAL

Treosulfan: 14 g/m² i.v. on 3 consecutive days (day -6 to -4)

Drug: Treosulfan

Interventions

Treosulfan DRUG

10 g/m² i.v. infusion, day -6, -5, -4

Also known as: Ovastat

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• medac GmbH: lead

Study Sites (7)

Helsinki University Central Hospital

Helsinki, FIN-00290, Finland

Location

Charité University Hospital Berlin

Berlin, 12203, Germany

Location

University Hospital Hamburg Eppendorf

Hamburg, 20246, Germany

Location

5th Medical Clinic, Clinic North

Nuremberg, 90340, Germany

Location

University Hospital Rostock

Rostock, 18057, Germany

Location

Silesian Medical University

Katowice, 40-029, Poland

Location

Karolinska University Hospital & Karolinska Institute

Stockholm, 141 86, Sweden

Location

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

treosulfan

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Mathias Freund, MD

  University Hospital Rostock

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 3, 2010
• First Posted: February 5, 2010
• Study Start: November 1, 2001
• Primary Completion: June 1, 2005
• Study Completion: June 1, 2006
• Last Updated: November 3, 2023

Record last verified: 2023-11

Locations

PL (1); FI (1); DE (4); SE (1)