An analysis of Leukapheresis as a prophylactic modality of therapy for â??Tumor Lysis Syndromeâ?? compared to conventional management alone: a pilot open labelled Randomized control trial

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2023
INTERVENTION: Intervention1: Leukapheresis: The patient allocated to the intervention arm (prophylactic Leukapheresis) with conventional management of Leukemia for TLS which includes increased hydration & Rasburicase, according to patient condition.Baseline investigations before Leukapheresis & chemotherapy will be compared with day 7 of chemotherapy and day 28 for mortality. Control Intervention1: Conventional management of Tumour Lysis Syndrome: Conventional management of Tumour lysis syndrome is with increased intravenous hydration at the rate of upto 3L/msq/day & Rasburicase with patient monitoring CONDITION: Health Condition 1: C910‐ Acute lymphoblastic leukemia [ALL] Health Condition 2: C925‐ Acute myelomonocytic leukemia Health Condition 3: C92Z‐ Other myeloid leukemia PRIMARY OUTCOME: 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 â??day 7â?? 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 OUTCOME: N/ATimepoint: N/A 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 & â?§ 25,000/ µl with prechemotherapy LDH â?§2 X(times) upper limit of normal value categorised as intermediate risk TLS.
Epistemonikos ID: 03fc45b7b8e3c49a011aa10cec12afc7c2c71dde
First added on: Feb 20, 2024