Hematological malignancy MedDRA version: 14.0 Level: LLT Classification code 10066481 Term: Hematological malignancy System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
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Pharmaceutical Form: Solution for injection
Trade Name: Thymoglobuline
Pharmaceutical Form: Powder for solution for infusion
Trade Name: Fludara
Pharmaceutical Form: Powder for
Sponsors
CHU Nantes
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Children and adolescents under the age of 18 years - Availability of an HLA identical family donor or an HLA-matched unrelated donor (10/10 or 9/10 if the mismatch level is at HLACw for an unrelated donor) - Informed consent signed by patient’s legal representative, parent(s) or guardian. - Diagnosis of a hematologic malignancy which is a candidate for allo-HSCT, but not eligible for standard or conventional myeloablative conditioning regimens because of high risk for toxicity. - Are considered as criteria of eligibility for non-standard or conventional myeloablative conditioning: * a history of autologous or allogeneic stem cell transplantation * comorbidities or medical history predictive of a prohibitive rate of TRM and toxicity with the use of standard high dose chemotherapy and / or radiotherapy. - Eligible hematologic malignancies treatable with allogeneic hematopoietic cell transplantation include: acute and chronic leukemias, myelodysplasia [MDS], or lymphomas. ? Patients with ALL are required to be in morphologic remission (=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Patient has been administered any other systemic chemotherapeutic drug (including Gemtuzumab) within 21 days prior to trial enrollment and start of the conditioning regimen. Hydroxyurea is permitted if indicated to control induction refractory disease, and IT chemotherapy is allowed if indicated as maintenance treatment for previously diagnosed leptomeningeal disease, that has been in remission for at least 3 months prior to enrollment on this study. - Active infection. Protocol PI will be final arbiter if there is uncertainty regarding whether a previous infection is resolved. - Age =18 years - A donor who is HLA mismatched at the level of more than one locus. - Poor performance status - Life expectancy is severely limited by concomitant illness and expected to be 1L prior to drainage. - HIV-positive. - Female pregnancy (all females of child-bearing-potential). - Patient’s legal representative, parent(s) or guardian not able to sign informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess transplant-related mortality (TRM) at one year after allogeneic hematopoietic stem cell transplantation prepared by a "reduced toxicity myeloablative" conditioning regimen;Secondary Objective: - Incidence of engraftment (neutrophils and platelets recovery after transplantation) - Incidence and severity of acute GVHD - Incidence and severity of chronic GVHD - Rate of disease relapse at one year after transplantation - Disease-free survival at one year after transplantation - Overall Survival at one year after transplantation - Immune Recovery (to be determined in a subgroup of patients) ;Primary end point(s): Evaluation of the cumulative incidence of TRM at 12 months after transplantation | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Incidence of engraftment defined as the first day of neutrophil (>500/µl for 3 consecutive days). Engraftment failure is defined as neutrophil <500/µl at day+42 after allo-SCT. - Evaluation of overall (OS) and disease-free survival (DFS) at 1 year after transplantation - Cumulative incidence of relapse, death from disease, and non-relapse mortality (NRM) - Cumulative incidences and severity of acute and chronic Graft-versus-Host disease - Immune Recovery parameters | — |
Countries
France
Contacts
Public ContactDirection de la Recherche
CHU Nantes
Outcome results
None listed