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evaluation of toxicity and efficacy of a transplantation program with high dose cyclophosphamide post transplant as GVHD prophylaxis in patients who underwent to allo transplant after RIC.

High-dose cyclophosphamide role in the prophylaxis of GVHD in elderly patients (66-70 years) with acute leukemia or myelodysplasia high-risk, submitted to allogenic transplant of peripheral hematopoietic progenitor cells after reduced-intensity conditioning. - transplant over66

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2012-004118-33-IT
Enrollment
Unknown
Registered
2012-12-19
Start date
2013-06-17
Completion date
Unknown
Last updated
2014-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Elderly patients (66-70 years) with acute leukemia or high-risk MDS who, underwent allogenic transplant of peripheral hematopoietic progenitors after reduced-intensity conditioning. MedDRA version: 15.1 Level: LLT Classification code 10018653 Term: Graft-versus-host disease System Organ Class: 100000004870

Interventions

Trade Name: ENDOXAN BAXTER*INIET 1FL 1G Pharmaceutical Form: Powder for solution for injection INN or Proposed INN: CYCLOPHOSPHAMIDE MONOHYDRATE CAS Number: 6055-19-2 Concentration unit: g gram(s) Con

Sponsors

AZIENDA OSPEDALIERA OSPEDALE NIGUARDA CA' GRANDA (A.O. DI RILIEVO NAZIONALE)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: LAM high risk [intermediate or poor risk cytogenetics - normal karyotype with unfavorable molecular alterations - failure of the 1st cycle of induction - secondary leukemia - second complete remission] in complete remission High-risk MDS (IPSS = intermediate II) ALL in complete remission Age> 66 years and =65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

Exclusion criteria: Age> 70 years Psychiatric disorders or other conditions that compromise adequate compliance to the therapeutic program Karnofsky score 2.5 vv normal value) or acute hepatitis Deficits in lung function (FEV1, FVC, DLCO <50% of the expected after correction for hemoglobin) HIV (Human Immunodeficiency Virus) HIV Obesity morbigena, or third-degree Infections in the active phase A history of cancer of other organs and tissues not in remission or at high risk of recurrence if prolonged immunosuppressive therapy.

Design outcomes

Primary

MeasureTime frame
Main Objective: The primary objective is the NRM to 90 days after allogenic transplant peripheral blood stem cells after reduced-intensity conditioning in a population of elderly patients (66-70 years) with LA / high-risk MDS.;Secondary Objective: Secondary objectives are evaluation engraftment, chimerism, incidence of acute and chronic GVHD, DFS, OS and NRM at one year post-transplant.;Primary end point(s): Mortality not related to recurrence disease in the first 90 days.;Timepoint(s) of evaluation of this end point: 90 days—

Secondary

MeasureTime frame
Secondary end point(s): Secondary objectives are evaluation rate of engraftment, full chimerism, incidence of acute and chronic GVHD, DFS, OS and NRM at one year post-transplant.;Timepoint(s) of evaluation of this end point: NA—

Countries

Italy

Contacts

Public ContactDr Giovanni Grillo

Ematologia

giovanni.grillo@ospedaleniguarda.it0264442668

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026