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

April 19, 2016 updated by: Sheba Medical Center

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Tel-Hashomer, Israel, 52621
        • Chaim Sheba Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
disease-free survival
Time Frame: 2 years after transplantation
2 years after transplantation

Secondary Outcome Measures

Outcome Measure
Time Frame
treatment-related mortality
Time Frame: 2 year after transplantation
2 year after transplantation
GVHD
Time Frame: 2 year after transplantation
2 year after transplantation
relapse
Time Frame: 2 year after transplantation
2 year after transplantation
overall survival
Time Frame: 2 year after transplantation
2 year after transplantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheba Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Anticipated)

April 1, 2018

Study Completion (Anticipated)

April 1, 2018

Study Registration Dates

First Submitted

March 1, 2010

First Submitted That Met QC Criteria

March 1, 2010

First Posted (Estimate)

March 2, 2010

Study Record Updates

Last Update Posted (Estimate)

April 20, 2016

Last Update Submitted That Met QC Criteria

April 19, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHEBA-09-7425-AN-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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