NCT02988466CompletedPhase 2
Reduced Intensity (RIC) Conditioning And Transplantation of HLA-Haplo-HCT
Reduced Intensity (RIC) Conditioning And Transplantation of HLA-Haploidentical Related Hematopoietic Cells (Haplo-HCT) For Patients With Hematologic Malignancies
Source: ClinicalTrials.gov · Last updated 28 May 2025
Brief summary (registry, in English)
This is a single institution phase II study of a reduced intensity conditioning (RIC) followed by a haploidentical hematopoietic cell transplant (haplo-HCT) in persons with diagnosis of hematologic malignancy. Conditioning will consists of fludarabine, cyclophosphamide, melphalan and total body irradiation (TBI) preparative regimen with a melphalan dose reduction for patients ≥55 years old and those with HCT Comorbidity Index (CI) \>3. This study uses a two-stage phase II design with accrual goal of 84 patients, using 28 patients separately for arms A, C and D
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 78 (actual)
- First submitted
- 7 Dec 2016
- Start date
- 24 Jan 2017
- Primary completion date
- 2 May 2023
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Diseases
- Acute lymphoblastic leukaemia, Myeloproliferative neoplasms, Follicular lymphoma, Hodgkin lymphoma, Chronic myeloid leukaemia, Myelodysplastic syndromes, Mantle cell lymphoma, Chronic lymphocytic leukaemia, Multiple myeloma, Acute myeloid leukemia, Childhood cancers
- NCT number
- NCT02988466
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 78
- From 24 Jan 2017 to the primary completion date, 2 May 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Current active and uncontrolled serious infection
- Acute leukemia in morphologic relapse/persistent disease defined as \> 5% blasts in normocellular bone marrow OR any % blasts if blasts have unique morphologic markers (e.g. Auer rods).
- Large cell lymphoma, mantle cell lymphoma and Hodgkin disease that is progressive on salvage therapy.
- stable non-bulky disease is acceptable.
- Active central nervous system malignancy
- Criteria For Donor Selection:
Age
- \< 70 years with an available 5-6/6 HLA-A, B, DRB1 matched sibling donor
- Eligible donors (14-70 years old) include biological children, siblings or half siblings, or parents, able and willing to undergo bone marrow harvesting.
- For donors \<18 years, the maximum recipient weight (actual body weight) should not exceed 1.25 times the donor weight (actual body weight)1 In addition, bone marrow product volume should be limited to 20 ml/kg donor weight for donors \<18 years.
Other
- Pregnancy or breastfeeding
- CML in blast crisis
- Donors must be HLA-haploidentical relatives of the patient, defined as having a shared HLA haplotype between donor and patient at HLA-A, -B, -C, and -DRB1.
Who the study is looking for
- Karnofsky performance status of ≥70% or Lansky play score ≥ 70%
- A related haploidentical bone marrow donor with up to 2 or 3 HLA locus-mismatches
- The donor and recipient must be HLA identical for at least one haplotype (using high resolution DNA based typing) at the following genetic loci: HLA-A, HLA-B, HLA-C, and HLA-DRB1.
- Adequate liver and renal function
- Absence of decompensated congestive heart failure, or uncontrolled arrhythmia and left ventricular ejection fraction ≥ 40%
- Diffusion capacity corrected (DLCOcorr) \> 40% predicted, and absence of O2 requirements
- \> 6 months after prior autologous transplant (if applicable)
- Agrees to use contraception during study treatment
- Voluntary written consent (adult or parent/guardian with presentation of the minor information sheet, if appropriate)
- Patients who are HIV+ must have undetectable viral load. All HIV+ patients must be evaluated by Infectious Disease (ID) and a HIV management plan establish prior to transplantation
Age in the registry: - to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Masonic Cancer Center at University of Minnesota Coordinator of this site? Confirm its status | Minneapolis | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.