High doses of cyclophosphamide for prophylaxis of GVHD in patients undergoing allogeneic transplantatio

Phase 1

• Conditions: Acute myeloid leukemia or myelodysplastic syndrome undergoing 1 antigen/allele mismatched (7/8 HLA matched) unrelated HCT; MedDRA version: 21.1Level: LLTClassification code 10068372Term: Prophylaxis against stem cell transplant rejectionSystem Organ Class: 100000004865; MedDRA version: 21.1Level: PTClassification code 10000880Term: Acute myeloid leukaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.1Level: PTClassification code 10028533Term: Myelodysplastic syndromeSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2017-003530-85-IT
• Lead Sponsor: GITMO GRUPPO ITALIANO PER IL TRAPIANTO DI MIDOLLO OSSEO, CELLULE STAMINALI EMOPOIETICHE E TERAPIA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-14
• Last Update Posted: 30 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 78

Inclusion Criteria

Patients >18 <65 years of age
Diagnosis of acute myeloid leukemia in complete remission (CR1, CR2) or myelodysplastic syndrome with indication for allo-HCT
No available HLA identical sibling donor or HLA matched (8/8) unrelated donor
Activation of an alternative donor search through IBMDR
Presence of a 1 antigen/allele mismatched (7/8 HLA matched) unrelated donor (loci: HLA-A, -B, -C, - DRB1)
ECOG Performance Status < 2
Written and signed informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 78
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Previous allogeneic HCT (autologous HCT is accepted)
Absence of informed consent
Serious organ dysfunction: left ventricular ejection fraction < 40%, FEV1, FVC, DLCO (diffusion capacity) <40% of predicted, LFT > 5 times the upper limit of normal, or creatinine clearance < 40 ml/min.

Study & Design

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