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

Phase 2

• Conditions: Hodgkin Lymphoma; Non Hodgkin Lymphoma
• Interventions: Drug: treosulfan

• Registration Number: NCT01079013
• Lead Sponsor: Sheba Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-03-01
• Study First Submitted QC: 2010-03-01
• Study First Posted: 2010-03-02
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-19
• Last Update Posted: 2016-04-20
• Primary Completion: 2018-04
• Study Completion: 2018-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
treosulfan	treosulfan	-

Primary Outcome Measures

Name	Time	Method
disease-free survival	2 years after transplantation

Secondary Outcome Measures

Name	Time	Method
relapse	2 year after transplantation
overall survival	2 year after transplantation
treatment-related mortality	2 year after transplantation
GVHD	2 year after transplantation

Trial Locations

Locations (1)

Chaim Sheba Medical Center; 🇮🇱 Tel-Hashomer, Israel