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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Non Hodgkin Lymphoma Hodgkin Lymphoma Chronic Lymphocytic Leukemia Multiple Myeloma | Drug: Thiotepa | Phase 2 |
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
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Drug: Thiotepa
Chemotherapy given prior to allogeneic stem cell transplantation |
- disease-free survival [ Time Frame: 2 years after transplantation ]The percentage of patients alive without disease recurrence 2 years after transplant
- treatment-related mortality [ Time Frame: 2 years after transplantation ]The percentage of patients who die of complications related to the transplant
- graft versus host disease [ Time Frame: 1 year after transplantation ]The percentage of patients experiencing graft-versus-host disease after transplant
- 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 |
Inclusion Criteria:
- Age less than physiologic 68 years.
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Patients with MM, NHL, HL and CLL with an indication for allogeneic transplantation as follows:
- MM; patients relapsing after autologous transplant or with high-risk cytogenetic abnormalities
- Aggressive lymphoma and Hodgkin lymphoma; relapse after autologous transplants
- Follicular lymphoma; failure of at least one prior regimen
- CLL; failure of prior therapy which includes Fludarabine combinations or 17p- cytogenetic abnormality
- 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
- Patients must sign written informed consent.
- Adequate birth control in fertile patients.
Exclusion Criteria:
- Bilirubin > 3.0 mg/dl, transaminases > 3 times upper normal limit
- Creatinine > 2.0 mg/dl
- ECOG-Performance status > 2
- Uncontrolled infection
- Pregnancy or lactation
- Abnormal lung diffusion capacity (DLCO < 40% predicted)
- Severe cardiovascular disease
- CNS disease involvement
- Pleural effusion or ascites > 1 liter
- Known hypersensitivity to Fludarabine or treosulfan
- Psychiatric conditions/disease that impair the ability to give informed consent or to adequately co-operate

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
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 |
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 |
Principal Investigator: | Arnon Nagler, MD | Chaim Sheba Medical Center |
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 |
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 |