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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2018-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Non Hodgkin Lymphoma Hodgkin Lymphoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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treosulfan

Group Type EXPERIMENTAL

treosulfan

Intervention Type DRUG

12 g/m2 x 3 days

Interventions

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treosulfan

12 g/m2 x 3 days

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

68 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No