Randomized comparison of Cyclophosphamide and ATG for prophylaxis of GvHD after unrelated donor transplantatio

Phase 1

Active, not recruiting

• Conditions: AML, t-MN, MDS, MDS/MPN, CMML-1/CMML-2; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2021-000853-17-DE
• Lead Sponsor: DKMS gemeinnuetzige GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-08
• Last Update Posted: 6 December 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 540

Inclusion Criteria

- Signed written Informed Consent and able to understand the nature of the trial and the trial related procedures and to comply with them (see Section 24.3).
- Age = 18 years.
- One of the following eligible diagnoses:
- AML in CR1 with intermediate or adverse risk genetic abnormalities (according to the ELN 2017 guidelines), or undefined risk.
- AML of any ELN risk category after hematological or molecular relapse, or with primary refractory disease.
- AML arising from myelodysplastic syndrome (MDS) or a myeloproliferative neoplasia, except if favourable genetic abnormalities (according to ELN 2017 guidelines) are present.
- Therapy-related myeloid neoplasia (t-MN), except if favourable genetic abnormalities (according to ELN 2017 guidelines) are present.
- MDS with intermediate risk, high risk or very high risk disease (according to the IPSS-R Score) regardless of treatment status.
- MDS/MPN and CMML-1/CMML-2 regardless of treatment status.
- Transplantation with Peripheral Blood Stem Cells (PBSC) scheduled to be performed 4 to 14 days after date of randomization.
- The left ventricular ejection fraction (LVEF) was assessed =40% at last echocardiography.
- The scheduled donor is unrelated to the patient, and matched or partially matched (with not more than one allele or antigen mismatch) at HLA-A, -B, -C, or -DRB1.
- Absence of pregnancy confirmed by highly sensitive pregnancy test for WOCBP (see Section 17.6). Test must not date back
- more than 3 days prior to randomization, or
- more than 3 days prior to start of conditioning, if it started before randomization.
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 540
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 540

Exclusion Criteria

- Anamnestic intravenous or subcutaneous exposure to rabbit immunoglobin-preparations (e.g. Grafalon? or Thymoglobulin?)
- Known hypersensitivity to ATG-Grafalon or its excipients.
- Known hypersensitivity to cyclophosphamide, its metabolites or excipients.
- Prior allogeneic hematopoietic transplantation.
- Patients who receive supplementary continuous oxygen at the time of randomization.
- Symptomatic heart failure (NYHA =2) at the time of randomization.
- Uncontrolled viral, bacterial or fungal infection with progression or no clinical improvement at the time of randomization.
- Symptomatic cystitis or known obstruction of urine flow at the time of randomization.
- Breast-feeding women.
- WOCBP and fertile male patients unable or unwilling to follow highly effective contraception methods from enrollment to minimum six months after the last dose of the IMP (see Section 17.6).
- Simultaneous participation in another interventional clinical trial with an investigational medicinal product.

Study & Design

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