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)
EU CTIS ID: 2024-518568-11-00
What this study is testing
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).
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Disease: 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; BHS-TC 14- Protocol Version 3.0 of 13JUNE2022 Page 10 / 32 - 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 RIC is preferred (eg CLL, MCL) • Continuation of maintenance with TKI are allowed after allo-HCT in case of Ph+ leukemia or FLT-3 mutated AML. Administration of other maintenance (defined as administration without evidence of relapse/progression of the underlying disease) treatments are not allowed in the protocol.
- 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.
You likely can't join if
- Exclusion criteria: • Any condition not fulfilling inclusion criteria; • HIV positive; • Non-hematological malignancy(ies) (except non-melanoma skin cancer) active < 3 years before HCT. • Life expectancy severely limited by disease other than malignancy; • CNS involvement with disease refractory to intrathecal chemotherapy. • Terminal organ failure, except for renal failure (dialysis acceptable) a. Cardiac: Symptomatic coronary artery disease; ejection fraction <40%; uncontrolled arrhythmia, uncontrolled hypertension; b. Pulmonary: DLCO < 40% and/or receiving supplementary continuous oxygen, FEV1< 40%; c. 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 ATG
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.