Clinical study in which are enrolled patients with malignant hematologic diseases for which there is no indication for allogeneic bone marrow transplantation, and for whom a suitable donor has been identified (fully compatible or partially compatible).

Phase 1

• Conditions: Pediatric and adult patients (aged from 1 to 70 years) with hematologic malignancies (leukemia, myeloma, lymphoma), candidates for allogeneic transplantation from HLA-identical or HLA-mismatched family is from the register.; MedDRA version: 14.1Level: PTClassification code 10001756Term: Allogenic bone marrow transplantation therapySystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2011-001534-42-IT
• Lead Sponsor: FONDAZIONE CENTRO S. RAFFAELE DEL MONTE TABOR

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-05-28
• Study Completion: 2016-06-16
• Last Update Posted: 26 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 67

Inclusion Criteria

Patients with hematological malignancies such as
- acute myeloid leukaemia -AML- in CR1 except low-risk
cases” defined by: t(15;17); t(8;21); inv 16; normal cytogenetics
at diagnosis with FLT3-ITD negative and NPM-1 positive (with
any high-risk clinical criteria).
- any AML beyond CR1
- acute lymphoblast leukaemia -ALL- in CR1 only if at high
risk” defined by cytogenetics as t(9;22), t(4;11), or for
persistence of minimal residual disease (MRD) after
consolidation.
- any ALL beyond CR1
- chronic myeloid leukaemia -CML- in chronic phase (CP) or
accelerated phase (AP) intolerant/not responsive to TKinhibitors,
in blastic phase (BP)
- myeloproliferative neoplasia –MPD-
- myelodysplastic syndrome -MDS- with intermediate or high
risk International Prognostic Scoring System (IPSS)
- diffuse large cell lymphoma –DLCL- with a chemosensitive
relapse or beyond CR1
- lymphoblastic and Burkitt lymphoma with a chemosensitive
relapse or beyond CR1
- mantle cell lymphoma –MCL- with a chemosensitive relapse
or beyond CR1
- follicular lymphoma –FCL- with a chemosensitive relapse or
beyond CR2
- Hodgkin lymphoma -HD- with a chemosensitive relapse or
beyond CR1
- chronic lymphocytic leukaemia –CLL- at poor risk” in CR1 or
with a chemosensitive relapse
- T-cell non Hodgkin lymphoma –T-NHL- in CR1 or beyond
- multiple myeloma –MM- at high risk for cytogenetics or ISS
stage 3 in CR1 following high dose chemotherapy
- MM at any relapse/progression, except refractory disease
· ECOG > 2
· Age < 70 years
· Adequate contraception in female patients of child-bearing
potential.
· Written informed consent
· Availability of one of the following:
· A matched related or unrelated donor (MRD or MUD)
· A mismatched related donor (MMRD) sharing at least one full
haplotype (MMRD)
· An unrelated donor satisfying the minimum criteria of a 5/6
antigen match at HLA-A, -B and -DRB1 (MMUD)
· A single cord blood unit (CBU) with a cellularity as follows:
6/6 TNC > 3x10e7/kg*
5/6 TNC > 4x10e7/kg*
4/6 TNC > 5x10e7/kg*
· If a single CBU doesn’t reach the target dose, then two CBUs are
preferred.
* This values are intented at the moment of collection.
Are the trial subjects under 18? yes
Number of subjects for this age range: 34
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 110
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

1. A hematopoietic cell transplantation-specific comorbidity index
(Sorror et al Appendix B) > 4
2. Active non-controlled infectious disease at the moment of inclusion
3. Active HBV or HCV infection
4. Impaired liver function (Bilirubin > 2.0 x upper normal limit;
Transaminases > 3.0 x upper normal limit)
5. Impaired renal function (Creatinine-clearance < 60 ml/min; Serum
Creatinine > 1.5 x upper normal limit).
6. Pleural effusion or ascites > 1.0 L
7. Pregnancy or lactation
8. Known hypersensitivity to treosulfan and/or fludarabine and/or
rapamycin
9. Non-co-operative behaviour or non-compliance
10. Psychiatric diseases or conditions that might impair the ability to give
informed consent

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified