NCT03852407 Allogeneic Hematopoietic Cell Transplantation From HLA-matched Donor After Flu-Mel-PTCy Versus Flu-Mel-ATG Reduced-intensity Conditioning
| NCT ID | NCT03852407 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Liege |
| Condition | Acute Myeloid Leukemia in Remission |
| Study Type | INTERVENTIONAL |
| Enrollment | 114 participants |
| Start Date | 2019-02-04 |
| Primary Completion | 2033-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 114 participants in total. It began in 2019-02-04 with a primary completion date of 2033-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Frédéric Baron, MD,Ph
PRINCIPAL INVESTIGATOR
Centre Hospitalier Universitaire de Liege
Frequently Asked Questions
Who can join the NCT03852407 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Acute Myeloid Leukemia in Remission. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03852407 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT03852407 currently recruiting?
Yes, NCT03852407 is actively recruiting participants. Contact the research team at F.Baron@uliege.be for enrollment information.
Where is the NCT03852407 trial being conducted?
This trial is being conducted at Antwerp, Belgium, Bruges, Belgium, Brussels, Belgium, Brussels, Belgium and 6 additional locations.
Who is sponsoring the NCT03852407 clinical trial?
NCT03852407 is sponsored by University of Liege. The principal investigator is Frédéric Baron, MD,Ph at Centre Hospitalier Universitaire de Liege. The trial plans to enroll 114 participants.
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