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

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ClinicalTrials.gov Identifier: NCT02507479
Recruitment Status : Unknown
Verified April 2016 by Sheba Medical Center.
Recruitment status was:  Recruiting
First Posted : July 24, 2015
Last Update Posted : April 20, 2016
Sponsor:
Information provided by (Responsible Party):
Sheba Medical Center

Brief Summary:
The study hypotheses is that the introduction of dose escalated thiotepa, 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 Chronic Lymphocytic Leukemia Multiple Myeloma Drug: Thiotepa Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 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 Thiotepa and Allogeneic Hematopoietic Stem-cell Transplantation in Patients With Lymphatic Malignancies Including Multiple Myeloma, Non Hodgkin's, Hodgkin Lymphoma and CLL
Study Start Date : September 2015
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : July 2019


Arm Intervention/treatment
Experimental: thiotepa
Thiotepa 5-10 mg/kg/d x 2 days
Drug: Thiotepa
Chemotherapy given prior to allogeneic stem cell transplantation




Primary Outcome Measures :
  1. disease-free survival [ Time Frame: 2 years after transplantation ]
    The percentage of patients alive without disease recurrence 2 years after transplant


Secondary Outcome Measures :
  1. treatment-related mortality [ Time Frame: 2 years after transplantation ]
    The percentage of patients who die of complications related to the transplant

  2. graft versus host disease [ Time Frame: 1 year after transplantation ]
    The percentage of patients experiencing graft-versus-host disease after transplant

  3. relapse [ Time Frame: 2 years after transplantation ]
    The percentage of patients experiencing disease recurrence after transplant



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Ages Eligible for Study:   18 Years to 68 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age less than physiologic 68 years.
  2. Patients with MM, NHL, HL and CLL with an indication for allogeneic transplantation as follows:

    1. MM; patients relapsing after autologous transplant or with high-risk cytogenetic abnormalities
    2. Aggressive lymphoma and Hodgkin lymphoma; relapse after autologous transplants
    3. Follicular lymphoma; failure of at least one prior regimen
    4. CLL; failure of prior therapy which includes Fludarabine combinations or 17p- cytogenetic abnormality
  3. 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, -DQB) typing. The goal is to transplant > 3 x 106 CD34+ cells per kg body weight of the recipient
  4. Patients must sign written informed consent.
  5. Adequate birth control in fertile patients.

Exclusion Criteria:

  1. Bilirubin > 3.0 mg/dl, transaminases > 3 times upper normal limit
  2. Creatinine > 2.0 mg/dl
  3. ECOG-Performance status > 2
  4. Uncontrolled infection
  5. Pregnancy or lactation
  6. Abnormal lung diffusion capacity (DLCO < 40% predicted)
  7. Severe cardiovascular disease
  8. CNS disease involvement
  9. Pleural effusion or ascites > 1 liter
  10. Known hypersensitivity to Fludarabine or treosulfan
  11. Psychiatric conditions/disease that impair the ability to give informed consent or to adequately co-operate

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): NCT02507479


Contacts
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Contact: Avichai Shimoni, MD 972 3 530 5830 ashimoni@sheba.health.gov.il
Contact: Arnon Nagler, MD 9972 3 530 5830 a.nagler@sheba.health.gov.il

Locations
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Israel
Chaim Sheba Medical Center Recruiting
Tel-Hashomer, Israel, 52621
Contact: Arnon Nagler, MD    972 3 530 5830    a.nagler@sheba.health.gov.il   
Contact: Avichai Shimoni, MD    972 3 530 5303    ashimoni@sheba.health.gov.il   
Sub-Investigator: Avichai Shimoni, MD         
Chaim Sheba Medical Center Recruiting
Tel-Hashomer, Israel
Principal Investigator: Arnon Nagler, MD         
Sponsors and Collaborators
Sheba Medical Center
Investigators
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Principal Investigator: Arnon Nagler, MD Chaim Sheba Medical Center
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Responsible Party: Sheba Medical Center
ClinicalTrials.gov Identifier: NCT02507479    
Other Study ID Numbers: SHEBA-13-0874-AN-CTIL
First Posted: July 24, 2015    Key Record Dates
Last Update Posted: April 20, 2016
Last Verified: April 2016
Additional relevant MeSH terms:
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Lymphoma
Multiple Myeloma
Neoplasms, Plasma Cell
Leukemia, Lymphocytic, Chronic, B-Cell
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Leukemia, Lymphoid
Leukemia
Leukemia, B-Cell
Thiotepa
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs