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

Hodgkin Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01079013
• Other study ID #: SHEBA-09-7425-AN-CTIL
• Status: Active, not recruiting
• Phase: Phase 2
• First received: March 1, 2010
• Last updated: April 19, 2016
• Start date: March 2010
• Est. completion date: April 2018

Study information

• Verified date: April 2016
• Source: Sheba Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: April 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 68 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hodgkin Disease
• Hodgkin Lymphoma
• Lymphoma
• Lymphoma, Non-Hodgkin
• Non Hodgkin Lymphoma

Intervention

Drug:
• treosulfan
12 g/m2 x 3 days

Locations

Country	Name	City	State
Israel	Chaim Sheba Medical Center	Tel-Hashomer

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	disease-free survival		2 years after transplantation	Yes
Secondary	treatment-related mortality		2 year after transplantation	Yes
Secondary	GVHD		2 year after transplantation	Yes
Secondary	relapse		2 year after transplantation	Yes
Secondary	overall survival		2 year after transplantation	Yes