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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Sheba Medical Center
Sponsor:
Information provided by (Responsible Party):
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT01079013
First received: March 1, 2010
Last updated: November 22, 2013
Last verified: November 2013
  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: Allocation: Non-Randomized
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: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: treosulfan Drug: treosulfan
12 g/m2 x 3 days

  Eligibility

Ages Eligible for Study:   18 Years to 68 Years
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: NCT01079013

Contacts
Contact: Avichai Shimoni, MD 972 3 530 5303 ashimoni@sheba.health.gov.il
Contact: Arnon Nagler, MD 972 3 530 5830 a.nagler@sheba.health.gov.il

Locations
Israel
Chaim Sheba Medical Center Recruiting
Tel-Hashomer, Israel, 52621
Contact: Avichai Shimoni, MD    972 3 530 5303    ashimoni@sheba.health.gov.il   
Principal Investigator: Arnon Nagler, MD         
Sponsors and Collaborators
Sheba Medical Center
Investigators
Principal Investigator: Arnon Nagler, MD Chaim Sheba Medical Center
  More Information

No publications provided

Responsible Party: Sheba Medical Center
ClinicalTrials.gov Identifier: NCT01079013     History of Changes
Other Study ID Numbers: SHEBA-09-7425-AN-CTIL
Study First Received: March 1, 2010
Last Updated: November 22, 2013
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Additional relevant MeSH terms:
Hodgkin Disease
Lymphoma
Lymphoma, Non-Hodgkin
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Treosulfan
Alkylating Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014