Two Step Haplo With Radiation Conditioning

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorThomas Jefferson University

About this trial

This phase II clinical trial evaluates whether a modified modality of conditioning reduces treatment-related mortality (TRM) in patients who undergo a hematopoietic stem cell transplant (HSCT) for a hematological malignancy. HSCT is a curative therapy for many hematopoietic malignancies, however this regimen results in higher rates of TRM than other forms of treatment. In recent years, less intense conditioning regimens with radiation and chemotherapy prior to HSCT have been developed. Radiation therapy uses high energy sources to kill cancer cells and shrink tumors while chemotherapy drugs like fludarabine and cyclophosphamide work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. This study evaluates whether a two-step approach with lower-intensity regimens of these treatments prior to HSCT reduces the rate of TRM.

Eligibility criteria

Qualifiers

Acute myeloid leukemia

Acute lymphoid leukemia in remission

Myelodysplasia (MDS)

Chronic lymphocytic leukemia (CLL) with no or minimal lymph node involvement

Disqualifiers

None

Trial design

Treatments tested in this trial

  • Fludarabine
  • Total-Body Irradiation
  • Donor Lymphocyte Infusion
  • Cyclophosphamide
  • Tacrolimus
  • Mycophenolate Mofetil
  • Hematopoietic Cell Transplantation
  • Melphalan
  • Bone Marrow Aspiration and Biopsy
  • Diagnostic Imaging
  • Biospecimen Collection

Treatment groups

63 Participants
are divided into 3 treatment groups

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Sidney Kimmel Cancer Center at Thomas Jefferson UniversityRecruiting19107, Philadephia, PennsylvaniaUnited StatesUnited States

Sponsors and collaborators