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

ConditionsAcute Myeloid Leukemia in RemissionMyelodysplastic SyndromesChronic Myeloid Leukemia in RemissionMyeloproliferative SyndromeMyeloproliferative DisorderAcute Lymphoid Leukemia in RemissionMultiple MyelomaChronic Lymphoid LeukemiaNon Hodgkin LymphomaHodgkin Lymphoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversity of Liege

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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,

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Thymoglobulin

    Drug

    ATG: 2.5 mg /kg/day on day -2 and -1 (day 0 is allogenic transplantation)

  • Melphalan

    Drug

    100mg/m² on day -2

  • Fludarabine

    Drug

    30mg/m² on days -6, -5, -4, -3, and -2

  • Cyclophosphamid

    Drug

    50 mg/kg on days +3 and +4.

Treatment groups

114 Participants
are divided into 2 treatment groups
Group A: Fludarabine-Melphalan-CyclophosphamideExperimental treatment 3 interventions
Group B: Fludarabine-Melphalan-thymoglobulinExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Current GVHD-free, relapse-free survival (cGRFS)

To assess the current GVHD-free, relapse-free survival (cGRFS) for patients in the 2 arms

Time frame
15 years (the primary endpoint will be first assessed after 191 events have been reached)

Secondary outcomes

1

cGRFS according donor

To assess cGRFS for patients conditioned with FM-PTCy or FM-ATG separately in those transplanted with a related or an unrelated donor

Time frame
15 years
2

Relapse/progression rate

To assess the relapse/progression rate for patients conditioned with FM-PTCy or FM-ATG

Time frame
15 years
3

Rate aGVHD

To assess rate of grade II-IV and III-IV acute GVHD (Graft-versus-host disease) in patients conditioned with FM or FM-ATG.

Time frame
6 months
4

Rate cGVHD

To assess rate of grade of moderate-severe chronic GVHD in patients conditioned with FM or FM-ATG.

Time frame
24 months

Other outcomes

1

Hematopoietic engraftment

To assess hematopoietic (whole blood and T cell chimerism) engraftment in the 2 arms.

Time frame
2 years
2

Quality of immunologic reconstitution

To assess the quality of immunologic reconstitution in the 2 arms

Time frame
5 years
3

Timing of immunologic reconstitution

To assess the timing (days) of immunologic reconstitution in the 2 arms

Time frame
5 years
4

Incidences of bacterial infections

To assess the incidences of bacterial infections (number of episode, site, grade) in the 2 arms, in the whole group of patients

Time frame
1 year

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Liege

Lead sponsor

Belgian Hematological Society

Collaborator

Source ClinicalTrials.gov
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