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

Multiple Myeloma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02507479
• Other study ID #: SHEBA-13-0874-AN-CTIL
• 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

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukemia
• Hodgkin Disease
• Hodgkin Lymphoma
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid
• Lymphoma
• Lymphoma, Non-Hodgkin
• Multiple Myeloma
• Neoplasms, Plasma Cell
• Non Hodgkin Lymphoma

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