Treosulfan-based Conditioning for Allogeneic Stem-cell Transplantation (SCT) in Lymphoid Malignancies

Phase II Trial of Fludarabine Combined With Intravenous Treosulfan and Allogeneic Hematopoietic Stem-cell Transplantation in Patients With Lymphatic Malignancies

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01079013

Enrollment

Registered

2010-03-02

Start date

2010-03-31

Completion date

2018-04-30

Last updated

2016-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hodgkin Lymphoma, Non Hodgkin Lymphoma

Brief summary

The study hypotheses is that the introduction of dose escalated treosulfan, in substitution to busulfan or melphalan, will reduce toxicity after allogeneic transplantation while improving disease eradication in patients with lymphoid malignancies not eligible for standard transplantation.

Interventions

DRUGtreosulfan

12 g/m2 x 3 days

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 68 Years

Healthy volunteers

Inclusion criteria

1. Age less than physiologic 68 years. 2. Patients with NHL and HL with an indication for allogeneic transplantation as follows: * Aggressive lymphoma and Hodgkin lymphoma; relapse after autologous transplants * Follicular lymphoma; failure of at least one prior regimen 3. Disease must be at chemo-sensitive or stable status to prior therapy before transplant. 4. Patients must have an HLA matched related or unrelated donor willing to donate either peripheral blood stem cells or bone marrow. Matching is based on high-resolution class I (HLA-A, -B, -C) and class II (HLA-DRB1, -DQB1) typing. The goal is to transplant \> 3 x 106 CD34+ cells per kg body weight of the recipient 5. Patients must sign written informed consent 6. Adequate birth control in fertile patients

Exclusion criteria

1. Overt progressive disease prior to transplantation. 2. Bilirubin \> 3.0 mg/dl, transaminases \> 3 times upper normal limit 3. Creatinine \> 2.0 mg/dl 4. ECOG-Performance status \> 2 5. Uncontrolled infection 6. Pregnancy or lactation 7. Abnormal lung diffusion capacity (DLCO \< 40% predicted) 8. Severe cardiovascular disease 9. CNS disease involvement 10. Pleural effusion or ascites \> 1 liter 11. Known hypersensitivity to fludarabine or treosulfan 12. Psychiatric conditions/disease that impair the ability to give informed consent or to adequately co-operate

Design outcomes

Primary

Measure	Time frame
disease-free survival	2 years after transplantation

Secondary

Measure	Time frame
treatment-related mortality	2 year after transplantation
GVHD	2 year after transplantation
relapse	2 year after transplantation
overall survival	2 year after transplantation

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026