Two Step Haplo With Radiation Conditioning

Part of paid clinical trials in Philadephia, Pennsylvania.

Sponsor
Thomas Jefferson University
Study ID
NCT05031897
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Fludarabine — DRUG
    Given IV
  • Total-Body Irradiation — RADIATION
    Undergo TBI
  • Donor Lymphocyte Infusion — PROCEDURE
    Undergo DLI
  • Cyclophosphamide — DRUG
    Given IV
  • Tacrolimus — DRUG
    Given IV
  • Mycophenolate Mofetil — DRUG
    Given IV
  • Hematopoietic Cell Transplantation — PROCEDURE
    Undergo HSCT
  • Melphalan — DRUG
    Given IV
  • Bone Marrow Aspiration and Biopsy — PROCEDURE
    Undergo bone marrow aspiration/ biopsy
  • Diagnostic Imaging — PROCEDURE
    Undergo diagnostic imaging
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection

Study Details

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.

Key Dates

Start date
Oct 25, 2021
Status verified
Oct 2025
Primary completion
Apr 30, 2032
Completion
Apr 30, 2032

Study Design

Enrollment
63 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1: Radiation-Based Cohort (fludarabine, TBI, infusion)
    Patients receive fludarabine IV on days -11, -10, -9, and -8, undergo TBI BID on days -10 and -9, undergo DLI on day -6, and receive cyclophosphamide IV on days -3 and -2. Patients begin tacrolimus and mycophenolate mofetil IV on day -1. Patients then undergo HSCT on day 0. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients undergo bone marrow biopsy/aspiration, imaging and blood sample collection throughout the study.
  • Experimental: Arm 2: Chemotherapy-Based Cohort (fludarabine, melphalan, TBI)
    Patients receive fludarabine IV on days -11, -10, -9, and -8 and melphalan IV on days -10 and -9. Patients undergo TBI and DLI once on day -6. Patients receive cyclophosphamide IV on days -3 and -2 and begin tacrolimus and mycophenolate mofetil on day -1. Patients undergo hematopoietic stem cell transplant on day 0. Patients undergo bone marrow biopsy/aspiration, imaging and blood sample collection throughout the study.
  • Experimental: Arm 3: HLA- Identical cohort (radiation-based or chemotherapy-based conditioning)
    This group (HLA- Identical cohort), which is expected to be small, can undergo HSCT with radiation-based or chemotherapy-based conditioning. Due to small numbers of patients with available HLA identical related donors, this third, descriptive arm is included so that this group, too small in number for a free-standing study, are treated on clinical trial. This is also a separate arm of the study and the outcome of patients treated on this arm will be analyzed descriptively without statistical comparison or power analysis.

Primary Outcome Measure

Number of Participants Who Experience Treatment-Related Mortality (TRM) [ Time Frame: At 2 years post hematopoietic stem cell transplant (HSCT) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Sidney Kimmel Cancer Center at Thomas Jefferson UniversityPhiladephiaPennsylvania19107
Usama Gergis, MD
[email protected]
215-503-2455

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