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

S

Sheba Medical Center

Status and phase

Unknown
Phase 2

Conditions

Hodgkin Lymphoma
Non Hodgkin Lymphoma

Treatments

Drug: treosulfan

Study type

Interventional

Funder types

Other

Identifiers

NCT01079013
SHEBA-09-7425-AN-CTIL

Details and patient eligibility

About

The study hypotheses is that the introduction of dose escalated treosulfan, 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.

Enrollment

40 estimated patients

Sex

All

Ages

18 to 68 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

40 participants in 1 patient group

treosulfan
Experimental group
Treatment:
Drug: treosulfan

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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