Phase 1 Leukaemia Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged 12 years or older
• People who are able to understand and sign a consent form that meets ethics committee requirements
• People whose leukaemia has been confirmed as pre B-cell ALL through laboratory testing of tissue or blood cells
• People whose leukaemia has come back after a second complete remission, or whose leukaemia did not respond to one cycle of re-induction treatment, or who still have detectable leukaemia cells after two or more cycles of initial treatment
• People who are willing to have a lumbar puncture (a procedure to collect fluid from around the spine) for testing and to receive chemotherapy this way
• People aged 12 to under 16 who meet a minimum physical functioning score (Lansky score above 60%), or people aged 16 and over who meet a low disability score (ECOG score of 0 or 1) (confirm with trial site if unsure which applies)
• People whose doctors expect them to survive for more than 16 weeks
• People who are willing and able to follow all study procedures and attend all required visits and follow-up appointments
• People who agree to use effective contraception during the study and for a set period after the last dose of study medication — this applies to females who could become pregnant and to males who have not been surgically sterilised

Who may not be able to join:

• People with T-cell leukaemia or Burkitt's leukaemia (a specific type called M3)
• People with a known allergy or sensitivity to any component of the study medication, including sulfa-containing substances such as DMSO
• People whose kidneys or liver are not functioning adequately, based on specific blood test results (confirm specific thresholds with trial site)
• People with a serious uncontrolled illness that would make the study treatment too risky
• People with a history of significant autoimmune disease, or an active autoimmune condition requiring high-dose steroid treatment (such as lupus or certain blood disorders)
• People who have had a bone marrow or stem cell transplant from a donor and still require ongoing treatment for graft versus host disease
• People who have received an organ transplant from a donor and still require immune-suppressing medication
• People who have had a solid organ transplant and later developed a high-grade blood cancer or leukaemia
• People with non-cancerous brain or nervous system conditions such as stroke, epilepsy, or neurodegenerative disease
• People with a current or past history of inflammatory bowel disease, such as Crohn's disease or ulcerative colitis
• People with uncontrolled high blood pressure, or significant heart or blood vessel problems including recent stroke, heart attack within the past 6 months, unstable chest pain, significant heart failure, or serious heart rhythm problems requiring medication
• People who have been taking high-dose steroid tablets or injections continuously for more than 3 months (inhaled steroids are not included in this restriction)
• People currently taking any medication — prescribed or herbal — known to interact badly with the study medications
• People with HIV whose immune cell counts are low and whose virus is still detectable in the blood
• People who are currently carriers of hepatitis B with an active infection confirmed by a positive surface antigen test
• People who have another active cancer, other than certain common skin cancers (basal or squamous cell carcinoma)
• People whom the study investigator considers unable or unwilling to follow the study requirements
• People who are pregnant or breastfeeding

Important: Always verify eligibility with the trial site directly before applying.