Image Guided total marrow lymphoid irradiation (TMLI)for blood cancer

A phase I study of the safety and feasibility of using Image Guided total marrow lymphoid irradiation (TMLI) as conditioning regimen for patients undergoing hematopoietic stem celI transplantation (HSCT) for acute lymphoblastic leukaemia. - TMLI

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/02/017648

Enrollment

Registered

2019-02-13

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C910- Acute lymphoblastic leukemia [ALL]

Interventions

Intervention1: Total marrow lymphoid irradiation (TMLI): Total marrow lymphoid irradiation (TMLI) and Cyclosphosphamide. Patients will receive TMLI along with cyclophosphamide as part of their conditi

Eligibility

Inclusion criteria

Inclusion criteria: Patients with acute lymphoblastic leukemia requiring TBI based conditioning. Age between 12 - 60 years

Exclusion criteria

Exclusion criteria: Age Use of matched unrelated or haplo-identical donors Creatinineclearance Active infections at the time of transplant Cardiac ejection fraction Abnormal liver function (Total bilirubin, SGOT or SGPT) > 3 times ULN.

Design outcomes

Primary

Measure	Time frame
SafetyofadministeringescalateddosesofTMLIincombinationwith Cyclophosphamide based on grade 4 toxicity to major organsTimepoint: 28 days, 2 years, 3 years	—

Secondary

Measure	Time frame
Engraftmentratesandchimerismatday28 Overallincidenceofacuteandchronicgraftversushostdisease. Relapse rates within the first 3 years Three year overall and disease free survival Time taken for contouring of the target volumes and OARs. Time taken to deliver one fraction of radiation (machine in â?? machine out time) including the treatment positioning, position verification using Cone Beam CT(CBCT) on the treatment machine and treatment delivery.Timepoint: 3 Years	—

Measure

Time frame

Engraftmentratesandchimerismatday28 Overallincidenceofacuteandchronicgraftversushostdisease. Relapse rates within the first 3 years Three year overall and disease free survival Time taken for contouring of the target volumes and OARs. Time taken to deliver one fraction of radiation (machine in â?? machine out time) including the treatment positioning, position verification using Cone Beam CT(CBCT) on the treatment machine and treatment delivery.Timepoint: 3 Years

—

Countries

India

Contacts

Public ContactBiju George

Christian Medical College, Vellore

biju@cmcvellore.ac.in04162282352

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026