Efficacy of the antiCD38 Monoclonal Antibody Isatuximab i... | NCT05559827

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Isatuximab arm	Experimental	Isatuximab treatment at a dose of 10 mg/kg by intravenous route. The first injection of isatuximab will be performed at randomization (month 6 +/- 2 days). A second injection may be performed at day 15 if the reticulocytes <10 G / L, and a third at day 29 if reticulocytes <10 G / L. Patients will be assessed on day 1, day 15, day 29, day 45, 2 months, 3 months, 6 months and 9 months after randomization.	Drug: Isatuximab
comparator arm	No Intervention	No treatment, supportive care will be allowed.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Isatuximab	Drug	Isatuximab treatment at a dose of 10 mg/kg by intravenous route. The first injection of isatuximab will be performed at randomization (month 6 +/- 2 days). A second injection may be performed at day 15 if the reticulocytes <10 G / L, and a third at day 29 if reticulocytes <10 G / L. Patients will be assessed on day 1, day 15, day 29, day 45, 2 months, 3 months, 6 months and 9 months after randomization.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
time interval between randomization (corresponding to the M6 post-transplant) and resolution of PRCA (date of resolution of reticulocytopenia) treated or not by the anti-CD 38 monoclonal antibody isatuximab		9 months post randomization

Secondary Outcomes

Measure	Description	Time Frame
Number of red blood cell transfusions after randomization		from randomization through study completion, an average of 9 months after randomization
Ferritin levels		at month 6 post-transplant

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Aged 15 years or older
Having receiving an allogeneic hematopoietic stem cell transplantation in condition of major ABO mismatch
PCRA defined by persistent red blood cell transfusion dependence at day 60 post-transplant with reticulocytes count under 10 G/L despite full donor chimerism and a good leucocytes (>1 G/L) and platelet (>50G/L) recovery
No relapse or progression of underlying disease
Contraception methods must be prescribed during all the duration of the research and using effective contraceptive methods during treatment for women of childbearing age (continue abstinence from heterosexual intercourse is accepted) and for man during the study treatment period and for at least 5 months after the last dose of study treatment and refrain from donating sperm during this period
With health insurance coverage
Having signed a written informed consent (2 parents for patients aged less than 18)

Exclusion Criteria:

Aged < 15 years
Relapse of underlying disease
Leucocyte chimerism < 95%
PRCA related to Parvovirus B19 infection (positive blood PCR)
Known to be HIV+ or to have hepatitis A, B, or C active infection
Active tuberculosis
Pregnancy (βHCG positive) or breast-feeding.
Patient receiving recombinant human erythropoietin.
Patient receiving proteasome inhibitor (Bortezomib for example).
Patient receiving thrombopoietin receptor agonists (ARTPO).
Patient receiving plasma or plasmapheresis exchanges after transplant.
Planned to receive any investigational drug within 14 days or 5 half-lives of the investigational drug, whichever is longer.
Any clinically significant, uncontrolled medical conditions that, in the Investigator's opinion, would expose excessive risk to the patient or may interfere with compliance or interpretation of the study results.
Hypersensitivity to the active substance or history of intolerance to steroids, mannitol, pregelatinized starch, sodium stearyl fumarate, histidine (as base and hydrochloride salt), arginine, hydrochloride, poloxamer 188, sucrose or any of the other components of study therapy that are not amenable to premedication with steroids and H2 blockers or would prohibit further treatment with these agents.
Who have any debilitating medical or psychiatric illness
Under tutorship or curatorship
Who not understand informed consent for an optimal treatment and follow-up

Name	Role	Phone	Extension	Email
Aliénor XHAARD	Contact	+33142385073		alienor.xhaard@aphp.fr
Matthieu Resche-Rigon	Contact	+33142499742		matthieu.resche-rigon@u-paris.fr