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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01079013
First Posted: March 2, 2010
Last Update Posted: April 20, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sheba Medical Center
  Purpose
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: 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

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 ]

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

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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 68 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01079013


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

Responsible Party: Sheba Medical Center
ClinicalTrials.gov Identifier: NCT01079013     History of Changes
Other Study ID Numbers: SHEBA-09-7425-AN-CTIL
First Submitted: March 1, 2010
First Posted: March 2, 2010
Last Update Posted: April 20, 2016
Last Verified: April 2016

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Treosulfan
Busulfan
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Myeloablative Agonists