Allogeneic Hematopoietic Cell Transplantation From HLA-matched Donor After Flu-Mel-PTCy Versus Flu-Mel-ATG Reduced-intensity Conditioning: a Phase II Randomized Study From the Belgian Hematology Society (BHS)

Who is this study for? Adult patients with Acute Myelogenous Leukemia, Acute Lymphocytic Leukemia, Myelodysplastic Syndrome, Non-Hodgkin's Lymphoma, Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, or Hodgkin's Lymphoma
Status: Recruiting
Location: See all (10) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

The present project aims at comparing two conditioning regimens (FM-PTCy vs FM-ATG). The hypothesis is that one or the two regimens will lead to a 2-year cGRFS rate improvement from 30% (the cGRFS rate with FM without ATG/PTCy) to 45% (Pick-a-winner phase 2 randomized study).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

∙ 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.

Locations
Other Locations
Belgium
ZNA Stuivenberg
RECRUITING
Antwerp
AZ Sint Jan Brugge
RECRUITING
Bruges
IJ Bordet
RECRUITING
Brussels
UCL St Luc
RECRUITING
Brussels
UZ Brussel
RECRUITING
Brussels
UZ Gent
RECRUITING
Ghent
UZ Leuven
RECRUITING
Leuven
CHU de Liège
RECRUITING
Liège
AZ Delta Roeselare
RECRUITING
Roeselare
CHU UCL Namur Godinne
RECRUITING
Yvoir
Contact Information
Primary
Frédéric Baron, MD,Ph
F.Baron@uliege.be
+32 4 366 72 01
Time Frame
Start Date: 2019-02-04
Estimated Completion Date: 2038-11-01
Participants
Target number of participants: 114
Treatments
Experimental: Fludarabine-Melphalan-Cyclophosphamide
FM-PTCy conditioning will consist in IV fludarabine 30 mg/m2 on days -6, -5, -4, -3, and -2 (total dose 150 mg/m2), melphalan given at the dose of 100 mg/m2 on day -2, and cyclophosphamide 50 mg/kg on days +3 and +4.
Experimental: Fludarabine-Melphalan-thymoglobulin
FM-ATG conditioning will consist in IV fludarabine 30 mg/m2 on days -6, -5, -4, -3, and -2 (total dose 150 mg/m2), melphalan given at the dose of 100 mg/m2 on day -2, and ATG (Thymoglobulin®, Genzyme), at a dose of 2.5 mg/kg/d on days -2 and -1.
Sponsors
Leads: University of Liege
Collaborators: Belgian Hematological Society

This content was sourced from clinicaltrials.gov

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