NCT02122081

Organ-Sparing Marrow-Targeted Irradiation Before Stem Cell Transplant in Treating Patients With High-Risk Hematologic Malignancies

Completed Phase 1 Last updated 21 September 2023

What this trial tests

Phase 1 trial testing radiation therapy in Adult Acute Lymphoblastic Leukemia in Remission in 33 participants. Completed in 6 September 2022.

Timeline

27 July 2015

Primary endpoint
6 September 2022

6 September 2022

Quick facts

Lead sponsor	Sumithira Vasu
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	33
Start date	27 July 2015
Primary completion	6 September 2022
Estimated completion	6 September 2022
Sites	1 location across United States

Drugs / interventions tested

• radiation therapy
• cyclophosphamide (cyclophosphamide) — full drug profile →
• anti-thymocyte globulin
• tacrolimus (TACROLIMUS) — full drug profile →
• methotrexate — full drug profile →
• allogeneic bone marrow transplantation
• allogeneic hematopoietic stem cell transplantation — full drug profile →
• peripheral blood stem cell transplantation
• laboratory biomarker analysis

Conditions studied

• Adult Acute Lymphoblastic Leukemia in Remission — all drugs for Adult Acute Lymphoblastic Leukemia in Remission →
• Adult Acute Myeloid Leukemia in Remission — all drugs for Adult Acute Myeloid Leukemia in Remission →
• Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities — all drugs for Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities →
• Adult Acute Myeloid Leukemia With Del(5q) — all drugs for Adult Acute Myeloid Leukemia With Del(5q) →

Sponsor

Sumithira Vasu — full company profile →

Who can join

Adults 18 to 75, any sex, with Adult Acute Lymphoblastic Leukemia in Remission or Adult Acute Myeloid Leukemia in Remission. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This pilot clinical trial aims to assess feasibility and tolerability of using an LINAC based "organ-sparing marrow-targeted irradiation" to condition patients with high-risk hematological malignancies who are otherwise ineligible to undergo myeloablative Total body irradiation (TBI)-based conditioning prior to allogeneic stem cell transplant. The target patient populations are those with ALL, AML, MDS who are either elderly (\>50 years of age) but healthy, or younger patients with worse medical comorbidities (HCT-Specific Comorbidity Index Score (HCT-CI) \> 4). The goal is to have the patients benefit from potentially more efficacious myeloablative radiation based conditioning approach without the side effects associated with TBI.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Two-miRNA-based finger-stick assay for estimation of absorbed ionizing radiation dose.
   Yadav M, Bhayana S, Liu J, Lu L, et al · · 2020 · cited 35× · PMID 32669422 · DOI 10.1126/scitranslmed.aaw5831
2. Total Body Irradiation in Haematopoietic Stem Cell Transplantation for Paediatric Acute Lymphoblastic Leukaemia: Review of the Literature and Future Directions.
   Hoeben BAW, Wong JYC, Fog LS, Losert C, et al · · 2021 · cited 33× · PMID 34926349 · DOI 10.3389/fped.2021.774348
3. Maintain Efficacy and Spare Toxicity: Traditional and New Radiation-Based Conditioning Regimens in Hematopoietic Stem Cell Transplantation.
   Dogliotti I, Levis M, Martin A, Bartoncini S, et al · · 2024 · cited 6× · PMID 38473227 · DOI 10.3390/cancers16050865