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

• Sponsor: Sheba Medical Center (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01079013
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arm: 1
• Duration (Months): 97
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Non Hodgkin Lymphoma; Hodgkin Lymphoma	Drug: treosulfan	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase II Trial of Fludarabine Combined With Intravenous Treosulfan and Allogeneic Hematopoietic Stem-cell Transplantation in Patients With Lymphatic Malignancies
• Study Start Date: Mar 1, 2010
• Anticipated Primary Completion Date: Apr 1, 2018
• Anticipated Study Completion Date: Apr 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: treosulfan	Drug: treosulfan; 12 g/m2 x 3 days

Outcome Measures

Primary Outcome Measures

1. disease-free survival [2 years after transplantation]

Secondary Outcome Measures

1. treatment-related mortality [2 year after transplantation]

2. GVHD [2 year after transplantation]

3. relapse [2 year after transplantation]

4. overall survival [2 year after transplantation]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 68 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

1. Disease must be at chemo-sensitive or stable status to prior therapy before transplant.

2. 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

3. Patients must sign written informed consent

4. 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chaim Sheba Medical Center	Tel-Hashomer		Israel	52621

Sponsors and Collaborators

• Sheba Medical Center

Investigators

• Principal Investigator: Arnon Nagler, MD, Chaim Sheba Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sheba Medical Center
• ClinicalTrials.gov Identifier: NCT01079013
• Other Study ID Numbers: SHEBA-09-7425-AN-CTIL
• First Posted: Mar 2, 2010
• Last Update Posted: Apr 20, 2016
• Last Verified: Apr 1, 2016

• Additional relevant MeSH terms: Lymphoma; Treosulfan

Study Results

No Results Posted as of Apr 20, 2016