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

Summary

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.

Conditions

• Adult Acute Lymphoblastic Leukemia in Remission
• Adult Acute Myeloid Leukemia in Remission
• Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
• Adult Acute Myeloid Leukemia With Del(5q)
• Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
• Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)
• Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
• Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
• de Novo Myelodysplastic Syndromes
• Previously Treated Myelodysplastic Syndromes
• Recurrent Adult Acute Lymphoblastic Leukemia
• Recurrent Adult Acute Myeloid Leukemia
• Secondary Myelodysplastic Syndromes
• Untreated Adult Acute Lymphoblastic Leukemia
• Untreated Adult Acute Myeloid Leukemia

Interventions

RADIATION

radiation therapy

Undergo organ-sparing marrow irradiation BID on days -6 to -4

DRUG

cyclophosphamide

Given IV over 1-2 hours every 24 hours on days -3 to -2.

BIOLOGICAL

anti-thymocyte globulin

DRUG

tacrolimus

Given IV or PO

DRUG

methotrexate

Given IV

PROCEDURE

allogeneic bone marrow transplantation

Undergo allogeneic peripheral blood progenitor cell or bone marrow transplant on day 0

PROCEDURE

allogeneic hematopoietic stem cell transplantation

Undergo allogeneic peripheral blood progenitor cell or bone marrow transplant

PROCEDURE

peripheral blood stem cell transplantation

Undergo allogeneic peripheral blood progenitor cell or bone marrow transplant

OTHER

laboratory biomarker analysis

Correlative studies

Sponsors & Collaborators

• Sumithira Vasu

  lead OTHER

Principal Investigators

• Sumithira Vasu, MD · Ohio State University Comprehensive Cancer Center

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-07-27

Primary Completion

2022-09-06

Completion

2022-09-06

FDA Device

Yes

Countries

• United States

Study Locations