Graft-versus-host response after reduced-intensity conditioning allogeneic peripheral blood stem cell transplantatio

Phase 1

• Conditions: Women and men with a hematologic malignancy for which a reduced-intensity conditioning allo-SCT is indicated; MedDRA version: 19.0Level: PTClassification code 10053239Term: Prophylaxis against graft versus host diseaseSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2016-002129-12-FR
• Lead Sponsor: ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-11-23
• Last Update Posted: 16 November 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

- Patients aged between 18 and 65 years
- Presence of a hematologic malignancy for which a reduced-intensity conditioning allo-SCT is indicated (eligibility criteria for RIC allo-SCT include at least one of the following parameters: (i) patient age older than 50 years; (ii) heavily pre-treated patients who received an autologous hematopoietic SCT (auto-SCT) or with more than 2 lines of chemotherapy before allo-SCT ; and (iii) patients with poor performance status because of significant medical comorbidities as described by Sorror et al.
- Karnofsky index ? 70%
- Availability of a sibling or unrelated stem-cell donor (10/10-HLA matched unrelated donor)
- Efficient contraceptive method within 1 month for women and 3 months for men after the last dose of treatment
- Written informed consent.
- Affiliation to a social security system (recipient or assign)

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 88
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Creatinine clearance less than 30 mL/min
- Bilirubin or amino-transferases above 3X upper normal limit
- Cardiac ejection fraction less than 40%
- Pulmonary impairment with <50% lung carbon monoxide diffusing capacity (DLCO)
- Known hypersensitivity or contraindication to the use of post-transplant Cy and ATG
- Any circumstance that precludes the use of the drugs involved in the protocol
- Pregnancy or breast-feeding women

Study & Design

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