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Reduced Intensity Fludarabine and TBI Prior to Haplo-Identical Transplantation

ConditionHematologic Malignancy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorNorthside Hospital, Inc.

About this trial

This trial will evaluate the safety and efficacy of RIC HIDT transplant protocol following fludarabine and intermediate-dose TBI 800 cGy utilizing PBSC as the stem cell source.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Availability of 3/6 - 5/6 matched related donor with a negative HLA-cross match in the host vs. graft direction willing to donate peripheral blood stem cells

KPS >/= 70%

Hematologic malignancy requiring allogeneic transplantation, with a predicted high risk of relapse following non-myeloablative, low intensity conditioning.

Disqualifiers

Poor cardiac function (LVEF <45%)

Poor pulmonary function (FEV, FVC, DLCO <60%)

Poor liver function (bilirubin >/= 2.5mg/dL; AST or ALT >3xULN)

Poor renal function (creatinine clearance <40mL/min)

Trial population

Male or female patients with any hematologic malignancy that requires an allogeneic transplant from a halpo-identical matched related donor

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Fludarabine

    Other intervention

    Reduced-intensity fludarabine with intermediate-dose TBI

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Compare the time to recovery of circulating neutrophils and platelets of all patients to determine incidence of graft rejection

Time frame
30 days after transplant

Secondary outcomes

1

Number of patients who are still alive as assessed by survival status at certain timepoints after transplant

Time frame
36 months after transplant
2

Number of patients with relapsed disease as assessed by labs, bone marrow biopsies and radiological scans at certain timepoints after transplant

Time frame
36 months after transplant
3

Number of patients with evidence of graft versus host disease as assessed by weekly progress notes after transplant

Time frame
36 months after transplant
4

Number of participants who died in the absence of relapse or progression as assessed by survival status at certain timepoints after transplant

Time frame
1 year after transplant

Other outcomes

Sponsors and contacts

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

Northside Hospital, Inc.

Lead sponsor

Source ClinicalTrials.gov
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