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

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02507479

Enrollment

Registered

2015-07-24

Start date

2015-09-30

Completion date

2019-07-31

Last updated

2016-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DRUGThiotepa

Chemotherapy given prior to allogeneic stem cell transplantation

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 68 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
disease-free survival	2 years after transplantation	The percentage of patients alive without disease recurrence 2 years after transplant

Secondary

Measure	Time frame	Description
treatment-related mortality	2 years after transplantation	The percentage of patients who die of complications related to the transplant
graft versus host disease	1 year after transplantation	The percentage of patients experiencing graft-versus-host disease after transplant
relapse	2 years after transplantation	The percentage of patients experiencing disease recurrence after transplant

Countries

Israel

Contacts

Primary ContactAvichai Shimoni, MD

ashimoni@sheba.health.gov.il972 3 530 5830

Backup ContactArnon Nagler, MD

a.nagler@sheba.health.gov.il9972 3 530 5830

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026