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Unrelated Reduced Intensity Conditioning With Treosulfan® for Allogeneic Stem Cell Transplantation in Patients With Hematological Malignancies


Phase 2
18 Years
65 Years
Open (Enrolling)
Both
Hematological Malignancies, Allogeneic Transplantation

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Trial Information

Unrelated Reduced Intensity Conditioning With Treosulfan® for Allogeneic Stem Cell Transplantation in Patients With Hematological Malignancies


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Overall survival at 1 year

Principal Investigator

Mauricette MICHALLET, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hospices Civils de Lyon

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

2003.332

NCT ID:

NCT00129155

Start Date:

February 2005

Completion Date:

Related Keywords:

  • Hematological Malignancies
  • Allogeneic Transplantation
  • Allogenic stem cell transplantation
  • Treosulfan
  • Haematological malignancies
  • allogeneic stem cell transplantation in patients with hematological malignancies
  • Neoplasms
  • Hematologic Neoplasms

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