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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02507479
Other study ID # SHEBA-13-0874-AN-CTIL
Secondary ID
Status Recruiting
Phase Phase 2
First received June 14, 2015
Last updated April 19, 2016
Start date September 2015
Est. completion date July 2019

Study information

Verified date April 2016
Source Sheba Medical Center
Contact Avichai Shimoni, MD
Phone 972 3 530 5830
Email ashimoni@sheba.health.gov.il
Is FDA regulated No
Health authority Israel: Israeli Health Ministry Pharmaceutical Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 24
Est. completion date July 2019
Est. primary completion date July 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 68 Years
Eligibility 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
Thiotepa
Chemotherapy given prior to allogeneic stem cell transplantation

Locations

Country Name City State
Israel Chaim Sheba Medical Center Tel-Hashomer
Israel Chaim Sheba Medical Center Tel-Hashomer

Sponsors (1)

Lead Sponsor Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary disease-free survival The percentage of patients alive without disease recurrence 2 years after transplant 2 years after transplantation Yes
Secondary treatment-related mortality The percentage of patients who die of complications related to the transplant 2 years after transplantation Yes
Secondary graft versus host disease The percentage of patients experiencing graft-versus-host disease after transplant 1 year after transplantation Yes
Secondary relapse The percentage of patients experiencing disease recurrence after transplant 2 years after transplantation Yes
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