Health Condition 1: C910- Acute lymphoblastic leukemia [ALL]
Conditions
Interventions
Intervention1: Niclosamide: vdhjvbvjdfvdf
Intervention2: Niclosamide: Niclosamide, originally developed by Bayer as an anti-parasitic drug, is being tested in this study as a potential anti-cancer age
Sponsors
ICMR (INDIAN COUNCIL OF MEDICAL RESEARCH)
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion criteria for Phase I - 1. Patients with relapsed ALL to be started on salvage treatment 2. Patients planned for intensive salvage induction chemotherapy: a. Group 1: UKALL R3 or UKALL R3-like protocol b. Group 2: UKALL R3 or UKALL R3-like protocol 3. Age: Patients will be grouped according to age into: a. Group 1: 2-18 years b. Group 2: 19 - 40 years 4. Both genders 5. ECOG Performance Status 0 to 2, determined by the treating physician 6. Both with B-ALL and T-ALL patients 7. All timelines of relapse very early, early or late relapse 8. All types of relapse - medullary, extramedullary and combined relapse 9. Normal cardiac, renal, and liver function 10. All patients meeting the aforementioned criteria irrespective of duration of remission Inclusion criteria for Phase II - 1. Patients with relapsed ALL to be started on salvage treatment 2. Patients planned for intensive salvage induction chemotherapy: UKALL R3 or UKALL R3-Like protocol 3. Age: 2 to 40 years 4. Both genders 5. ECOG Performance Status 0 to 2, determined by the treating physician 6. Both with B-ALL and T-ALL patients 7. All timelines of relapse very early, early or late relapse 8. All types of relapse - medullary, extramedullary and combined relapse 9. Normal cardiac, renal, and liver function 10. All patients meeting the aforementioned criteria irrespective of duration of remission
Exclusion criteria
Exclusion criteria: Exclusion criteria for both Phase I and Phase II - 1. Ph-positive ALL 2. Active complicated infections, as per the discretion of the treating physician 3. HIV or Hepatitis B or C positive patients 4. Pregnant and lactating women 5. Patients on certain medications that have the potential to exhibit significant drug interactions with Niclosamide
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| In the Phase I study, the following outcomes will be measured from assessment of Toxicities throughout 28-day study period: 1. Maximum tolerated dose (MTD) 2. Optimal Phase 2 recommended dose (P2RD) of Niclosamide In the Phase II study the following will be assessed: 1. Response rates through assessment of Complete Remission and Minimal Residual Disease status Timepoint: PHASE I: 28 Days (daily) PHASE II: Baseline, 28 Days and 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| PHASE I: 1. Pharmacokinetic Parameters (Cmax, Tmax etc.) Phase II: 1. Biomarker levels (apoptosis, autophagy, immunomodulatory and gut microbiome) 2. Survival outcomes (Leukemia free survival and Overall survival)Timepoint: For Pharmacokinetic Analysis in Phase I: Day 1: Samples to be collected before dosing at baseline and then after Niclosamide dose at 0.5hr, 1hr, 1.5hr, 2hr, 3hr, 4hr, 6hr, 8hr, 10hr, 12hr, 24hr. Day 14 - sample will be collected before drug administration and 1hr and 2hr post dose. (To validate if a steady dose is being attained) Day 28 and 29 - pre-dose on day 28 and on the 30th hour after the last dose. Sparse sampling will be done to minimize burden on patients. For Phase II: Biomarker levels - Baseline, Day 8 and end of week 4. Survival Outcomes will be assessed over a period of 1 year for each patient. | — |
Countries
India
Contacts
Public ContactDr Smita Kayal
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER)
Outcome results
None listed