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Phase II Trial of Fludarabine Combined With Intravenous Treosulfan and Allogeneic Hematopoietic Stem-cell Transplantation in Patients With Lymphatic Malignancies


Phase 2
18 Years
68 Years
Open (Enrolling)
Both
Non Hodgkin Lymphoma, Hodgkin Lymphoma

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Trial Information

Phase II Trial of Fludarabine Combined With Intravenous Treosulfan and Allogeneic Hematopoietic Stem-cell Transplantation in Patients With Lymphatic Malignancies


Inclusion Criteria:



1. Age less than physiologic 68 years.

2. Patients with NHL and HL with an indication for allogeneic transplantation as
follows:

- Aggressive lymphoma and Hodgkin lymphoma; relapse after autologous transplants

- Follicular lymphoma; failure of at least one prior regimen

3. Disease must be at chemo-sensitive or stable status to prior therapy before
transplant.

4. 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, -DQB1) typing. The goal is to
transplant > 3 x 106 CD34+ cells per kg body weight of the recipient

5. Patients must sign written informed consent

6. Adequate birth control in fertile patients

Exclusion Criteria:

1. Overt progressive disease prior to transplantation.

2. Bilirubin > 3.0 mg/dl, transaminases > 3 times upper normal limit

3. Creatinine > 2.0 mg/dl

4. ECOG-Performance status > 2

5. Uncontrolled infection

6. Pregnancy or lactation

7. Abnormal lung diffusion capacity (DLCO < 40% predicted)

8. Severe cardiovascular disease

9. CNS disease involvement

10. Pleural effusion or ascites > 1 liter

11. Known hypersensitivity to fludarabine or treosulfan

12. Psychiatric conditions/disease that impair the ability to give informed consent or to
adequately co-operate

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

disease-free survival

Outcome Time Frame:

2 years after transplantation

Safety Issue:

Yes

Principal Investigator

Arnon Nagler, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Chaim Sheba Medical Center

Authority:

Israel: Israeli Health Ministry Pharmaceutical Administration

Study ID:

SHEBA-09-7425-AN-CTIL

NCT ID:

NCT01079013

Start Date:

March 2010

Completion Date:

March 2014

Related Keywords:

  • Non Hodgkin Lymphoma
  • Hodgkin Lymphoma
  • Hodgkin Disease
  • Lymphoma
  • Lymphoma, Non-Hodgkin

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