Allogeneic Hematopoietic Cell Transplantation From HLA-matched Donor After Flu-Mel-PTCy Versus Flu-Mel-ATG Reduced-intensity Conditioning

  • STATUS
    Recruiting
  • End date
    Nov 1, 2038
  • participants needed
    114
  • sponsor
    University of Liege
Updated on 25 January 2021
cancer
remission
chronic myeloid leukemia
stem cell transplantation
myeloid leukemia
lymphoid leukemia
fludarabine
hematologic malignancy
blast crisis
chronic lymphocytic leukemia
hla-a
lymphoma
myelodysplastic syndromes
multiple myeloma
hodgkin's disease
hydroxyurea
melphalan
cell transplantation
leukemia
transplant conditioning
antithymocyte globulin
myeloproliferative syndromes
thymoglobulin
leukapheresis
white blood cells

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).

Description

This study is a multicenter, randomized, open-label, phase II study pick-a-winner study, comparing 2 conditioning regimens. A total of 114 eligible patients with HLA-matched donors will be randomized 1:1 between the FM-PTCy arm and the FM-ATG arm, with stratification for donor type (related or unrelated). The recruitment period is 3 years with a 5-year follow-up plus a 10-year additional long-term follow-up (for GVHD status, disease status, second malignancy and QOL). The whole study will be completed within 18 years.

Details
Condition Bone marrow disorder, Hodgkin's Disease, Multiple Myeloma, Lymphoma, Preleukemia, Lymphoproliferative Disorder, Lymphoma, Chronic Lymphocytic Leukemia, MYELOPROLIFERATIVE DISORDER, MYELODYSPLASTIC SYNDROME, Lymphocytic Leukemia, Chronic, Non-Hodgkin's Lymphoma, Myelodysplastic Syndromes (MDS), Acute Myeloid Leukemia in Remission, Myeloproliferative Syndromes, Myeloproliferative Neoplasms, Myeloproliferative Syndrome, Chronic Myeloid Leukemia in Remission, Lymphoproliferative disorders, Acute Lymphoid Leukemia in Remission, myelodysplastic syndromes, myeloproliferative neoplasm, myeloproliferative disorders, non-hodgkin's lymphoma (nhl), leukemia chronic lymphocytic, chronic lymphocytic leukemia (cll), small lymphocytic lymphoma, multiple myeloma (mm), myelodysplastic syndrome (mds), hodgkin, hodgkin's lymphomas, hodgkin lymphomas, hodgkins lymphoma, hodgkin's lymphoma
Treatment melphalan, Fludarabine, Thymoglobulin, Cyclophosphamid
Clinical Study IdentifierNCT03852407
SponsorUniversity of Liege
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 75 yrs?
Gender: Male or Female
Do you have any of these conditions: Chronic Lymphocytic Leukemia or Bone marrow disorder or MYELODYSPLASTIC SYNDROME or Lymphocytic Leukemia, Chronic or Preleukemia or Lymphoproliferativ...?
Do you have any of these conditions: Myelodysplastic Syndromes (MDS) or hodgkin's lymphomas or Lymphoma or MYELODYSPLASTIC SYNDROME or Myeloproliferative Syndromes or Hodgkin's Disease or...?
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)
Cardiac: Symptomatic coronary artery disease; ejection fraction <40%; uncontrolled arrhythmia, uncontrolled hypertension
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%
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
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