Dose-range Finding Treosulfan-based Conditioning

NCT ID: NCT01063647

Last Updated: 2023-11-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-11-30
• Study Completion Date: 2006-06-30

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

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

Group Type: EXPERIMENTAL

Treosulfan

Intervention Type: DRUG

10 g/m² i.v. infusion, day -6, -5, -4

2

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

Group Type: EXPERIMENTAL

Treosulfan

Intervention Type: DRUG

12 g/m² i.v. infusion, day -6, -5, -4

3

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

Group Type: EXPERIMENTAL

Treosulfan

Intervention Type: DRUG

14 g/m² i.v. infusion, day -6, -5, -4

Interventions

Treosulfan

10 g/m² i.v. infusion, day -6, -5, -4

Intervention Type: DRUG

Treosulfan

12 g/m² i.v. infusion, day -6, -5, -4

Intervention Type: DRUG

Treosulfan

14 g/m² i.v. infusion, day -6, -5, -4

Intervention Type: DRUG

Other Intervention Names

Ovastat; Ovastat; Ovastat

Eligibility Criteria

Inclusion Criteria

1. 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)

2. 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.

3. Age > 18 years

4. Karnofsky Index > 80 %

5. Adequate contraception in female patients of child-bearing potential

6. Co-operative behavior of individual patients

7. Written informed consent

Exclusion Criteria

1. Completely chemotherapy-resistant disease

2. Severe cardiac insufficiency, severe cardio-vascular or other severe concomitant diseases

3. Symptomatic malignant involvement of the CNS

4. Active infectious disease

5. HIV-positive or active hepatitis infection

6. Impaired liver function (Bilirubin > 1.5 x upper normal limit; Transaminases > 3.0 x upper normal limit)

7. Impaired renal function (Creatinine-clearance < 60 ml/min; Serum Creatinine > 1.5 x upper normal limit).

8. Pleural effusion or ascites > 1.0 L

9. Pregnancy or lactation

10. Known hypersensitivity to fludarabine and/or treosulfan

11. Parallel participation in another experimental drug trial

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

medac GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

medac GmbH

Principal Investigators

Mathias Freund, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Rostock

Locations

Helsinki University Central Hospital

Helsinki, , Finland

Charité University Hospital Berlin

Berlin, , Germany

University Hospital Hamburg Eppendorf

Hamburg, , Germany

5th Medical Clinic, Clinic North

Nuremberg, , Germany

University Hospital Rostock

Rostock, , Germany

Silesian Medical University

Katowice, , Poland

Karolinska University Hospital & Karolinska Institute

Stockholm, , Sweden

Countries

Finland; Germany; Poland; Sweden

Other Identifiers

MC-FludT.6/L

Identifier Type: -

Identifier Source: org_study_id