Marrow and Lymph Node Radiation for Bone Marrow Transplant in Leukemia

Total Marrow And Lymphoid Irradiation (TMLI) as Conditioning Regimen for Peripheral Stem Cell Transplant in High Risk/ Relapsed /Refractory Leukemias - TMLI

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/11/022162

Enrollment

Registered

2019-11-27

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: C969- Malignant neoplasm of lymphoid, hematopoietic and related tissue, unspecified

Interventions

Intervention1: Radiation: TMLI dose 13.2Gy/8# at 1.65Gy per fraction Control Intervention1: Not Applicable: Not Applicable

Eligibility

Inclusion criteria

Inclusion criteria: 1.Acute Lymphoblastic leukemia(ALL) high risk patients in CR1. 2.Relapsed ALL pts in CR2 or above. 3.Patients with AML, in CR1 with intermediate- to poor-risk molecular and cytogenetic prognostic features. 4.Acute Myeloid Leukemia(AML) patients with disease that is refractory or does not respond to initial induction chemotherapy, being in remission after treatment for relapse. 5.AML patients having disease that remains refractory after relapse.

Exclusion criteria

Exclusion criteria: 1.Patients who cannot tolerate standard TBI and myeloablative conditioning regimens (eg, those who are older than 60 years, have comorbid conditions) 2.Have previously received myeloablative conditioning regimens. 3.Have been heavily pretreated for relapse or refractory disease. 4.Patients previously treated with TBI. 5.Unable to understand and sign the Informed consent

Design outcomes

Primary

Measure	Time frame
Incidence of Grade III and IV Oral mucositis in TMLI.Timepoint: 100 days	—

Secondary

Measure	Time frame
1. Dosimetric comparison of critical organ doses and target coverage between Tomotherapy and VMAT for TMLI technique. 2. Toxicity rates : Acute with CTCAE version 5.0 ( Common Terminology Criteria for Adverse Events) 3. Cumulative incidence of grade III and IV Acute GVHD graded using Glucksberg grading system at 100 days. 4. Cumulative incidence of Chronic GVHD (beyond 100 days) at 1year and 2 years Timepoint: 2 years;7. Event free survival at 1 and 2 years (Event for this definition would include graft rejection, relapse, or death of any cause whichever happens first). 8. 100 day Non-relapse mortality (NRM)- defined as death from any cause other than relapse or refractory disease Timepoint: 2 years ; 5. Overall survival at 1 and 2 years (Event for this definition would include or death of any cause) 6. Progression free survival at 1 and 2 years (Event for this definition would include disease progression, relapse, or death of any cause whichever happens first). Timepoint: 2 years	—

Measure

Time frame

1. Dosimetric comparison of critical organ doses and target coverage between Tomotherapy and VMAT for TMLI technique. 2. Toxicity rates : Acute with CTCAE version 5.0 ( Common Terminology Criteria for Adverse Events) 3. Cumulative incidence of grade III and IV Acute GVHD graded using Glucksberg grading system at 100 days. 4. Cumulative incidence of Chronic GVHD (beyond 100 days) at 1year and 2 years Timepoint: 2 years;7. Event free survival at 1 and 2 years (Event for this definition would include graft rejection, relapse, or death of any cause whichever happens first). 8. 100 day Non-relapse mortality (NRM)- defined as death from any cause other than relapse or refractory disease Timepoint: 2 years ; 5. Overall survival at 1 and 2 years (Event for this definition would include or death of any cause) 6. Progression free survival at 1 and 2 years (Event for this definition would include disease progression, relapse, or death of any cause whichever happens first). Timepoint: 2 years

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Countries

India

Contacts

Public ContactDr Jayant S Goda

Tata Memorial Centre

godajayantsastri@gmail.com9930004414

Outcome results

None listed

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