Health Condition 1: C910- Acute lymphoblastic leukemia [ALL]
Conditions
Interventions
Intervention1: Bortezomib: Bortezomib 1.3mg/m2 once a week x 4 doses
Control Intervention1: Not applicable: Not applicable
Sponsors
Christian Medical College Vellore Investigator initiated Academic study
Eligibility
Inclusion criteria
Inclusion criteria: 1. Signed and dated written informed consent by start date of Screening visit in accordance with GCP and local legislation 2. Patients 40-60yrs of age with newly diagnosed B â??cell Acute lymphoblastic leukemia
Exclusion criteria
Exclusion criteria: i. Pre-existing neuropathy â?? as detected by either NCV or clinical examination ii. Philadelphia Positive acute lymphoblastic leukemia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of peripheral neuropathy post-induction (defined according to NIH criteria)21 Grade 2 by clinical assessment by NCIC-CTC grading Timepoint: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Incidence of morphological remission (assessment by bone marrow morphological examination as part of standard therapy) 2. Incidence of Minimal residual disease positivity (assessment by flow cytometry as part of standard therapy) 3. Incidence of subclinical peripheral neuropathy (detected by NCV)Timepoint: 6 months | — |
Countries
India
Contacts
Public ContactAnu Korula
Christian Medical College, Vellore
Outcome results
None listed