Health Condition 1: C910- Acute lymphoblastic leukemia [ALL] Health Condition 2: C925- Acute myelomonocytic leukemia Health Condition 3: C92Z- Other myeloid leukemia
Conditions
Interventions
Intervention1: Leukapheresis: The patient allocated to the intervention arm (prophylactic Leukapheresis) with conventional management of Leukemia for TLS which includes increased hydration & Rasburica
Sponsors
All India Institute of Medical Sciences Raipur
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion criteria: Leukapheresis for Hyperleukocytosis defined as Acute Myeloid leukemia on peripheral smear (PS) with WBC >100X109/l or Acute Lymphoblastic leukemia on PS with WBC >100X109/l or transformation of Chronic leukaemia with Blast count >20% (WBC >100X109/l) TLS Prophylaxis of AML/ALL with WBC <100,000/cumm & ? 25,000/ µl with prechemotherapy LDH ?2 X (times) upper limit of normal value categorised as intermediate risk TLS.
Exclusion criteria
Exclusion criteria: Exclusion criteria: The Exclusion criteria for the Treatment are as follows: i. Patients with clinical and Blood smear diagnosis other than Acute myeloid leukemia; Acute lymphoblastic leukemia or chronic leukemia with blast transformation classified a high or moderate risk TLS as mentioned in the inclusion criteria ii. Patient with Acute myeloid Leukemia (Promyelocytic FAB M3) on peripheral smear. iii. Unconscious or delirious patients who cannot provide a videographic consent. iv. Ongoing tumor lysis syndrome for prophylactic Leukapheresis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected Outcomes: The prophylactic Leukapheresis is expected to improve the biochemical parameters and prevent the onset of TLS as compared to the control group at ‘day 7’ of chemotherapy. Leukapheresis is expected to have no difference to an improvement in 28d mortality within experimental subjects.Timepoint: (s)Timelines: Details of activities to be carried out along with the timelines of the activities planned are detailed as follows: (a)Standardised format, SOP, Coordination among departments staff recruitment: 01 month (b)Patient recruitment: 08 months, (interim analysis at 5 months) (c)Data compilation: 02 months (d)Submission of report, project expenditure and project closure: 1 month. | — |
Secondary
| Measure | Time frame |
|---|---|
| N/ATimepoint: N/A | — |
Countries
India
Contacts
Public ContactDr Sankalp Sharma
All India Institute of Medical Sciences Raipur
Outcome results
None listed