Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Queen Mary University of London
With
Gilead Sciences
Age
16–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Aged 16 years or over
2. Confirmed diagnosis of recurrent or refractory B-precursor ALL \[according to the WHO classification\].
3. Greater than 5% blasts in the bone marrow
4. WHO/ECOG performance status of 0-2 and well enough to receive intensive combination chemotherapy.
5. Negative pregnancy test in women of childbearing potential. Women will not be considered of child bearing potential if they have undergone surgical removal of the uterus or are post menopausal and have been amenorrhoeic for at least 24 months.
6. Patients must have adequate organ function:
* Renal function - serum creatinine \<2.5 x ULN or eGFR\>50ml/min (measured EDTA or estimated creatinine clearance e.g Cockcroft \& Gault)
* Liver function (bilirubin/ALT \<2.5 x ULN)
7. Patients must be able to comply with the study schedule.
You may not be if
1. Patients should not have received chemotherapy for current episode of relapsed ALL (except corticosteroids for a maximum of 10 days, before joining the study).
2. Patients with co-morbidities: e.g. uncontrolled hypertension and or poorly controlled diabetes which in the PI's opinion makes them unsuitable for the study.
3. Patients with severe psychiatric disorders which in the PI's opinion makes them unsuitable for trial participation.
4. Females of childbearing potential and all males must be willing to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) for the duration of the study and for up to 3 months after the last dose of study medication. Note: Subjects are not considered of child bearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal.
5. Females of childbearing potential must have a negative pregnancy test within 7 days prior to starting the study.
6. Females must not be breastfeeding.
7. Patients may not receive any other investigational agent during the study.
8. Patients should not have received any antibody therapy within 3 months of joining this study.
Clareo Health | Monoclonal Antibodies in Recurrent or Refractory B Cell Acute Lymphoblastic Leukaemia (ALL) (MARALL)
