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Two Step Haplo With Radiation Conditioning

ConditionsAcute Lymphoblastic LeukemiaAcute Myeloid LeukemiaAdult T-Cell Leukemia/LymphomaAplastic AnemiaChronic Lymphocytic LeukemiaChronic Myeloid Leukemia, BCR-ABL1 PositiveChronic Myelomonocytic LeukemiaEssential ThrombocythemiaHematopoietic and Lymphatic System NeoplasmHodgkin LymphomaMultiple MyelomaMyelodysplastic SyndromeMyelofibrosisMyeloid NeoplasmNon-Hodgkin LymphomaPolycythemia VeraSmall Lymphocytic Lymphoma
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Fludarabine

    Drug

    Given IV

  • Total-Body Irradiation

    Radiation

    Undergo TBI

  • Donor Lymphocyte Infusion

    Procedure/Surgery

    Undergo DLI

  • Cyclophosphamide

    Drug

    Given IV

  • Tacrolimus

    Drug

    Given IV

  • Mycophenolate Mofetil

    Drug

    Given IV

  • Hematopoietic Cell Transplantation

    Procedure/Surgery

    Undergo HSCT

  • Melphalan

    Drug

    Given IV

  • Bone Marrow Aspiration and Biopsy

    Procedure/Surgery

    Undergo bone marrow aspiration/ biopsy

  • Diagnostic Imaging

    Procedure/Surgery

    Undergo diagnostic imaging

  • Biospecimen Collection

    Procedure/Surgery

    Undergo blood sample collection

Treatment groups

63 Participants
are divided into 3 treatment groups
Group A: Arm 1: Radiation-Based Cohort (fludarabine, TBI, infusion)Experimental treatment 10 interventions
Group B: Arm 2: Chemotherapy-Based Cohort (fludarabine, melphalan, TBI)Experimental treatment 11 interventions
Group C: Arm 3: HLA- Identical cohort (radiation-based or chemotherapy-based conditioning)Experimental treatment 11 interventions

Trial outcomes

Primary outcomes

1

Number of Participants Who Experience Treatment-Related Mortality (TRM)

TRM is defined as death without evidence of recurrent disease in the 2 year period post HSCT. Summarized using Kaplan-Meier curves and the respective Kaplan-Meier estimates of the 2-year event rate are reported as well as their 95% confidence intervals.

Time frame
At 2 years post hematopoietic stem cell transplant (HSCT)

Secondary outcomes

1

Development of relapsed disease

Relapse is measured by evidence of recurrent disease in the blood, marrow, or lymph nodes. Summarized using Kaplan-Meier curves and the respective Kaplan-Meier estimates of the 2-year event rate are reported as well as their 95% confidence intervals.

Time frame
Up to 2 years
2

Engraftment

Measure by chimerism studies of the blood and marrow at multiple time points after the HSCT. Chimerism refers to the percentage of donor cells in the hematopoietic system of the patient post HSCT. Reported using mean and standard deviations.

Time frame
Up to 2 years
3

Immune reconstitution

Evaluated by T-cell recovery and B-cell recovery. Assessed by the quantitative measurement of CD3/4 and CD3/8 cells and immunoglobulin levels in the blood at multiple time points post HSCT. CD3/4 and CD3/8 counts are measured by an immune reconstitution panel and immunoglobulin levels are measured by a quantitative immunoglobulin assay. Reported using mean and standard deviations

Time frame
Up to 2 years
4

Incidence and degree of graft versus host disease (GVHD) after HSCT

Assessment includes presence and degree of skin rash, presence and amount of diarrhea, and/or abnormal liver function test. Summarized using Kaplan-Meier curves and the respective Kaplan-Meier estimates of the 2-year event rate are reported as well as their 95% confidence intervals.

Time frame
Up to 2 years

Other outcomes

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 contacts

Click on the lead sponsor to view all of their trials.

Thomas Jefferson University

Lead sponsor

Source ClinicalTrials.gov
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