Comparing two conditioning regimens for allogeneic hematopoietic cell transplantation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, randomized, open-label phase II study aims to compare two conditioning regimens, FM-PTCy and FM-ATG, in patients with hematological malignancies who have HLA-matched donors. A total of 114 eligible patients will be randomized in a 1:1 ratio between the two arms, with stratification based on donor type. The study will follow participants for 5 years, with an additional 10 years for long-term outcomes related to graft versus host disease, disease status, and quality of life. The goal is to improve the 2-year cumulative graft rejection-free survival rate from 30% to 45%.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Patients V.1.1. Diseases

Hematological malignancies confirmed histologically:

* AML in morphological CR or not in morphological CR but not rapidly progressing (i.e. no need to give treatments such as hydroxyurea to maintain WBC count \< 10 000 x109/mL);
* MDS;
* CML in CP or AP;
* MPD not in blast crisis,
* MDS/MPD overlap,
* ALL in CR;
* Multiple myeloma;
* CLL;
* Non-Hodgkin's lymphoma (aggressive NHL should have chemosensitive disease);
* Hodgkin's disease with chemosensitive disease or responding to checkpoint inhibitors.

  \* Clinical situations

  • Theoretical indication for a standard allo-transplant, but not feasible because:
* Age \> 50 yrs;
* Unacceptable end organ performance;
* The physician's decision;
* The patient's decision

  * Underlying 'lower risk' disease, for which Reduced Intensity Conditioning is preferred (eg CLL, MCL)

    \* Other inclusion criteria
  * Male or female; fertile patients must use a reliable contraception method;
  * Age 18-75 yrs (children of any age are not allowed in the protocol);
  * Informed consent given by patient or his/her guardian if indicated.

Donors

* Male or female;
* Any age;
* Human Leukocyte Antigen (HLA)-identical sibling donor or 10 of 10 (HLA-A, -B, -C, -DRB1, and -DQB1) HLA allele matched unrelated donor;
* Weight \> 15 Kg (because of leukapheresis);
* Fulfills criteria for allogeneic Peripheral Blood Stem Cell (PBSC) donation according to standard procedures;
* Informed consent given by donor or his/her guardian if indicated, as per donor center standard procedures.

Exclusion Criteria:

Patients

* Any condition not fulfilling inclusion criteria;
* Human Immunodeficiency Virus positive;
* Non-hematological malignancy(ies) (except non-melanoma skin cancer) active \< 3 years before Hematopoietic Cell Transplantation (HCT).
* Life expectancy severely limited by disease other than malignancy;
* Central Nervous System involvement with disease refractory to intrathecal chemotherapy.
* Terminal organ failure, except for renal failure (dialysis acceptable)

  1. Cardiac: Symptomatic coronary artery disease; ejection fraction \<40%; uncontrolled arrhythmia, uncontrolled hypertension;
  2. Pulmonary: Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)\< 40% and/or receiving supplementary continuous oxygen, Forced Expiratory Volume in 1 Second (FEV1)\< 40%;
  3. Hepatic: Fulminant liver failure, cirrhosis of the liver with evidence of portal hypertension, alcoholic hepatitis, esophageal varices, a history of bleeding esophageal varices, hepatic encephalopathy, uncorrectable hepatic synthetic dysfunction evinced by prolongation of the prothrombin time, ascites related to portal hypertension, bacterial or fungal liver abscess, biliary obstruction, chronic viral hepatitis with total serum bilirubin \>3 mg/dL, and symptomatic biliary disease;
* Uncontrolled infection;
* Karnofsky Performance Score \<70%;
* Patient is a fertile man or woman who is unwilling to use contraceptive techniques during and for 12 months following treatment;
* Patient is a female who is pregnant or breastfeeding;
* Any condition precluding the use of melphalan or Thymoglobulin;

Donors

* Any condition not fulfilling inclusion criteria;
* Unable to undergo leukapheresis because of poor vein access or other reasons.

Where it's running

• ZNA Stuivenberg
  Antwerp, Belgium Recruiting
• AZ Sint Jan Brugge
  Bruges, Belgium Recruiting
• IJ Bordet
  Brussels, Belgium Recruiting
• UZ Brussel
  Brussels, Belgium Recruiting
• UCL St Luc
  Brussels, Belgium Recruiting
• UZ Gent
  Ghent, Belgium Recruiting

Study contacts

• Principal investigator: Frédéric Baron, MD,Ph — Centre Hospitalier Universitaire de Liege
• Study coordinator: Frédéric Baron, MD,Ph
• Email: F.Baron@uliege.be
• Phone: +32 4 366 72 01

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.