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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00129155
Other study ID # 2003.332
Secondary ID
Status Recruiting
Phase Phase 2
First received August 9, 2005
Last updated October 3, 2007
Start date February 2005

Study information

Verified date October 2007
Source Hospices Civils de Lyon
Contact Mauricette MICHALLET, MD
Phone 33 472 117 329
Email mauricette.michallet@chu-lyon.fr
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial Summary

In this study, treosulfan is evaluated for conditioning in allogenic stem cell transplantation. The procedure and the follow-up are the same as in standard allogenic transplant.

The donor is unrelated (identical HLA). The graft is haematological peripheral blood stem cell.

The conditioning with reduced intensity is: fludarabine (from day -6 to day -2), treosulfan (from day -6 to day -4) and thymoglobuline (from day -2 to day -1).


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- AGE: >= 18 years and <= 65 years

- Patients with a too high transplant-related mortality (TRM) after standard transplantation (multiple myeloma, chronic lymphoid leukemia, non Hodgkin's lymphoma, myelodysplasia)

- Patients with visceral contra-indication for standard transplantation:

- cardiac: myocardiopathy; forced expiratory volume (FEV) < 50%;

- respiratory: abnormal carbon monoxide diffusing capacity (DLCO);

- renal: creatinine clearance < 50ml/min;

- hepatic: transaminases and bilirubin > 2 upper normal limit;

- infectious: controlled fungal infection.

- Karnofsky score >= 70%

- Unrelated donor HLA identical (ABC, DRB1; DQB1)

- Signed informed consent

Diagnosis :

Chronic myelogenous leukemia (CML):

- In first chronic phase, resistant to interferon with or without aracytine or refractory or resistant to Glivec

- In complete response (CR) or in 2nd partial response (PR) after being in blastic phase

Multiple myeloma (MM):

- Relapse after autograft if the therapeutic response was evaluated to 50%

Non-Hodgkin's lymphoma (NHL):

- Mantle cell lymphoma after first relapse but in case of chemosensitivity = 50% except for high grade lymphoma

- In 2nd CR or PR chemosensitive in response = 50% after autograft

Chronic lymphocytic leukemia (CLL):

- In 2nd CR or PR or in response = 50% after autograft or in 2nd relapse after 2 lines of treatment but in case of chemosensitivity = 50%

Acute myeloid leukemia (AML):

- In 2nd CR or in 1st CR for high risk criteria [high risk criteria defined by: LAM 7; leukocytes > 30,000/mm3; chromosomal abnormalities: t(6,9); abnormalities of 11q23, 17p, 11q, 20q, 21q, -5, del(5q), -7/del7q, del 9q et inv 3q]

Acute lymphoblastic leukemia (ALL):

- In 2nd CR or in 1st CR if high risk criteria patients who are defined by chromosomal abnormalities t(9,22); t(1,19); t(4,11); abnormalities of 11q23

Myelodysplastic syndromes (MDS):

- Patients without prior chemotherapy, with intermediate or high International Prognostic Scoring System (IPSS) score and blast cells < 1% in bone marrow (BM)

- CR or PR after chemotherapy for patients with 20 to 30% of blast cells in BM

- Secondary AML patients with a response to chemotherapy (< 30% blasts in BM and < 5% of blast cells in blood)

For all:

- Adequate contraception in female patients of child bearing potential

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
treosulfan


Locations

Country Name City State
France Hôpital Edouard Herriot Lyon

Sponsors (1)

Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Overall survival at 1 year
Secondary Engraftment evaluation
Secondary Acute and chronic graft-versus-host disease incidence and severity
Secondary Response rate and survival without progression
Secondary Evaluation of conditioning and transplant toxicity
Secondary Chimerism evaluation
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