Image Guided total marrow lymphoid irradiation (TMLI)for blood cancer
Phase 1
- Conditions
- Health Condition 1: C910- Acute lymphoblastic leukemia [ALL]
- Registration Number
- CTRI/2019/02/017648
- Lead Sponsor
- Christian Medical College Vellore Investigator initiated Academic study
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Patients with acute lymphoblastic leukemia requiring TBI based conditioning.
Age between 12 - 60 years
Exclusion Criteria
Age < 12 years
Use of matched unrelated or haplo-identical donors Creatinineclearance <30ml/min
Active infections at the time of transplant
Cardiac ejection fraction < 50%
Abnormal liver function (Total bilirubin, SGOT or SGPT) > 3 times ULN.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method SafetyofadministeringescalateddosesofTMLIincombinationwith Cyclophosphamide based on grade 4 toxicity to major organsTimepoint: 28 days, 2 years, 3 years
- Secondary Outcome Measures
Name Time Method Engraftmentratesandchimerismatday28 <br/ ><br>Overallincidenceofacuteandchronicgraftversushostdisease. <br/ ><br>Relapse rates within the first 3 years <br/ ><br>Three year overall and disease free survival <br/ ><br>Time taken for contouring of the target volumes and OARs. <br/ ><br>Time taken to deliver one fraction of radiation (machine in â?? machine out time) <br/ ><br>including the treatment positioning, position verification using Cone Beam CT(CBCT) on the treatment machine and treatment delivery.Timepoint: 3 Years