Clinical Trials Directory

Trials / Completed

CompletedNCT02626715

Reduced-Intensity Conditioning (RIC) and Myeloablative Conditioning (MAC) for HSCT in AML/MDS

A Phase II Study of Myeloablative and Reduced-Intensity Conditioning Regimens for Children and Young Adults With Acute Myeloid Leukemia or Myelodysplastic Syndrome Undergoing Allogeneic Hematopoietic Stem Cell Transplantation

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
21 (actual)
Sponsor
Randy Windreich · Academic / Other
Sex
All
Age
0 Months – 26 Years
Healthy volunteers
Not accepted

Summary

The purpose of this study is to compare safety and efficacy of reduced-intensity conditioning and myeloablative conditioning regimens prior to HSCT in high-risk AML/MDS pediatric and young adult patients. This study investigates the use of two novel conditioning therapies for hematopoietic stem cell transplant (HSCT). The primary focus of both the investigators' myeloablative and reduced-intensity conditioning regimens is to reduce overall toxicity so that pediatric and young adult patients with high-risk AML/MDS with significant pretransplant comorbidities who would have been ineligible to proceed to HSCT previously can now receive potentially life-saving treatment.

Conditions

Interventions

TypeNameDescription
DRUGReduced-Intensity Conditioning RegimenCampath (alemtuzumab) - drug class: monoclonal antibody Droxia (hydroxyurea) - drug class: antimetabolite Fludara (fludarabine) - drug class: antimetabolite Alkeran (melphalan) - drug class: alkylating agent Thiotepa (triethylenethiophosphoramide) - drug class: cytotoxic agent
DRUGMyeloablative Conditioning RegimenCampath (alemtuzumab) - drug class: monoclonal antibody Thiotepa (triethylenethiophosphoramide) - drug class: cytotoxic agent Fludara (fludarabine) - drug class: antimetabolite Busulfex (busulfan) - drug class: alkylating agent

Timeline

Start date
2015-09-04
Primary completion
2023-04-12
Completion
2023-04-12
First posted
2015-12-10
Last updated
2024-07-16
Results posted
2024-07-16

Locations

1 site across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT02626715. Inclusion in this directory is not an endorsement.