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

NCT ID: NCT02507479

Last Updated: 2016-04-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2019-07-31

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.

Conditions

Non Hodgkin Lymphoma; Hodgkin Lymphoma; Chronic Lymphocytic Leukemia; Multiple Myeloma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

thiotepa

Thiotepa 5-10 mg/kg/d x 2 days

Group Type: EXPERIMENTAL

Thiotepa

Intervention Type: DRUG

Chemotherapy given prior to allogeneic stem cell transplantation

Interventions

Thiotepa

Chemotherapy given prior to allogeneic stem cell transplantation

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 68 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sheba Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Arnon Nagler, MD

Role: PRINCIPAL_INVESTIGATOR

Chaim Sheba Medical Center

Locations

Chaim Sheba Medical Center

Tel Litwinsky, , Israel

Site Status: RECRUITING

Chaim Sheba Medical Center

Tel Litwinsky, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Avichai Shimoni, MD

Role: CONTACT

ashimoni@sheba.health.gov.il

972 3 530 5830

Arnon Nagler, MD

Role: CONTACT

a.nagler@sheba.health.gov.il

9972 3 530 5830

Facility Contacts

Arnon Nagler, MD

Role: primary

a.nagler@sheba.health.gov.il

972 3 530 5830

Avichai Shimoni, MD

Role: backup

ashimoni@sheba.health.gov.il

972 3 530 5303

Other Identifiers

SHEBA-13-0874-AN-CTIL

Identifier Type: -

Identifier Source: org_study_id