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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Sheba Medical Center Identifier:
First received: March 1, 2010
Last updated: April 19, 2016
Last verified: April 2016
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 Intervention Phase
Non Hodgkin Lymphoma
Hodgkin Lymphoma
Drug: treosulfan
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • disease-free survival [ Time Frame: 2 years after transplantation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • treatment-related mortality [ Time Frame: 2 year after transplantation ] [ Designated as safety issue: Yes ]
  • GVHD [ Time Frame: 2 year after transplantation ] [ Designated as safety issue: Yes ]
  • relapse [ Time Frame: 2 year after transplantation ] [ Designated as safety issue: Yes ]
  • overall survival [ Time Frame: 2 year after transplantation ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: March 2010
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: treosulfan Drug: treosulfan
12 g/m2 x 3 days


Ages Eligible for Study:   18 Years to 68 Years
Genders Eligible for Study:   Both
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
  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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01079013

Chaim Sheba Medical Center
Tel-Hashomer, Israel, 52621
Sponsors and Collaborators
Sheba Medical Center
Principal Investigator: Arnon Nagler, MD Chaim Sheba Medical Center
  More Information

Responsible Party: Sheba Medical Center Identifier: NCT01079013     History of Changes
Other Study ID Numbers: SHEBA-09-7425-AN-CTIL 
Study First Received: March 1, 2010
Last Updated: April 19, 2016
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Additional relevant MeSH terms:
Hodgkin Disease
Lymphoma, Non-Hodgkin
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms by Histologic Type
Alkylating Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Molecular Mechanisms of Pharmacological Action processed this record on May 26, 2016