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Clinical Trials/CTRI/2024/06/068451
CTRI/2024/06/068451
Not yet recruiting
Phase 2

A Phase II open-label, randomized controlled trial evaluating the effect of early versus conventional calcineurin inhibitor and mycophenolate mofetil initiation in graft-versus-host disease (GVHD) prophylaxis on the incidence of acute grade 2-4 GVHD in patients undergoing T cell replete haploidentical stem cell transplantation using post-transplant cyclophosphamide - Nil

Indian Council of Medical Research0 sites0 target enrollmentTBD
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ConditionsHealth Condition 1: C920- Acute myeloblastic leukemia

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Health Condition 1: C920- Acute myeloblastic leukemia
Sponsor
Indian Council of Medical Research
Status
Not yet recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Interventional

Investigators

Eligibility Criteria

Inclusion Criteria

  • •Patients planned for haploidentical stem cell transplantation using post\-transplant cyclophosphamide

Exclusion Criteria

  • •1\. Patients planned for T cell depleted haplodentical stem cell transplantation
  • •2\. Patients with significant organ dysfunction (creatinine above 2mg%, liver enzymes above 5 times the upper limit of normal, LV ejection fraction less than 40%)
  • •3\. Patients with active infection at the time of transplant
  • •4\. Patients undergoing a second transplant

Outcomes

Primary Outcomes

Not specified

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