Health Condition 1: C910- Acute lymphoblastic leukemia [ALL]
Conditions
Interventions
Intervention1: Inotuzumab plus SOC: Inotuzumab will be administered at a dose of 0.3mg per m2 on days 22 and 29 of phase 1 induction.
Intervention2: Bortezomib plus SOC: Bortezomib will be administere
Sponsors
Dr Hasmukh Jain
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients aged 15 to 39 years old with newly diagnosed acute lymphoblastic leukemia as per the World Health Organization definition will be included in the study. 2. Treatment-naive patients will be included, except for those who have received up to 7 days of steroids or hydroxyurea or 1 dose of L-asparaginase. 3. Both B-lineage and T-lineage acute lymphoblastic leukemia, including T lymphoblastic lymphoma, will be considered for the study. 4. Eastern Cooperative Oncology Group performance status of 3 or lower. 5. Patients will be considered irrespective of the involvement of the central nervous system, testis, or other extramedullary sites. 6. Written informed consent or assent.
Exclusion criteria
Exclusion criteria: 1. Burkitts leukemia early T cell precursor acute lymphoblastic leukemia and lymphoid blast crisis in a case of myeloproliferative neoplasm 2. Contraindication to anthracyclines or any other intensive chemotherapy except if the abnormality is considered related to acute lymphoblastic leukemia itself a. Aspartate transaminase and or alanine transaminase greater than 5 times the upper limit of normal b. Total bilirubin greater than 2 point 5 times the upper limit of normal unless due to predominant indirect hyperbilirubinemia c. Serum creatinine greater than 2 times the upper limit of normal or creatinine clearance less than 50 milliliters per minute estimated by the Cockcroft Gault equation d. Myocardial infarction in the 6 months prior to enrollment or cardiomyopathy classified as New York Heart Association grade 3 or 4 left ventricular ejection fraction less than 50 percent ejection fraction assessment to be performed only if clinically indicated 3. Seropositive illness human immunodeficiency virus positive or active hepatitis B 4. Pregnant or nursing woman 5. Not willing to follow up as per the protocol 6. Intolerance to treatment with a monoclonal antibody 7. History of hypersensitivity to boron compounds 8. History of malignancy within 3 years before the date of enrollment except for squamous and basal cell carcinomas of the skin carcinoma in situ of the cervix or malignancies that in the opinion of the investigator are considered cured or do not warrant treatment during the intensive phase with minimal risk of recurrence within 3 years 9. Active or uncontrolled infections that make the patient unfit to receive therapy as per the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Event-free survival is defined as the time calculated from the date of randomization in the study to any event or last follow-up.Timepoint: At the end of 3 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Response RateTimepoint: At the end of induction Phase 1b day 64;BM or CNS Relapse from CR or CRiTimepoint: At the end of 3 years;MRD clearanceTimepoint: At the end of Day 35 or 64;Acute and long-term toxicitiesTimepoint: At the end of 3 years;Overall SurvivalTimepoint: At the end of 3 years | — |
Countries
India
Contacts
Public ContactHasmukh Jain
Tata Memorial Hospital
Outcome results
None listed