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An analysis of Leukapheresis as a prophylactic modality of therapy for ‘Tumor Lysis Syndrome’ compared to conventional management alone: A pilot open labelled Randomized control trial

Not Applicable
Conditions
Health Condition 1: C910- Acute lymphoblastic leukemia [ALL]Health Condition 2: C925- Acute myelomonocytic leukemiaHealth Condition 3: C92Z- Other myeloid leukemia
Registration Number
CTRI/2023/03/050636
Lead Sponsor
All India Institute of Medical Sciences Raipur
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Open to Recruitment
Sex
Not specified
Target Recruitment
0
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

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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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