Dose-range Finding Treosulfan-based Conditioning

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.

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Key information

Conditions

Hematological Malignancies Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Helsinki University Central Hospital, Helsinki, Finland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Treosulfan

Drug

10 g/m² i.v. infusion, day -6, -5, -4

Other names: Ovastat

Primary outcomes

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

Secondary outcomes

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

Time frame: 6 months

Sponsors and collaborators

Lead sponsor

medac GmbH

Industry

Registry information

Official study title

Allogeneic Hematopoietic Stem Cell Transplantation in Patients With Advanced Hematological Malignancies After Treosulfan-based Conditioning Therapy - A Clinical Phase II Study

Important dates

Study start: 2001
Primary completion: 2005
Study completion: 2006
First posted: Feb 5, 2010
Registry last updated: Nov 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed