Reduced Intensity (RIC) Conditioning And Transplantation of HLA-Haplo-HCT
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| ClinicalTrials.gov Identifier: NCT02988466 |
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Recruitment Status :
Recruiting
First Posted : December 9, 2016
Last Update Posted : February 28, 2022
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Sponsor:
Masonic Cancer Center, University of Minnesota
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota
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Brief Summary:
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
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Hematologic Malignancies | Biological: Haplo HCT <55 years old Biological: Haplo HCT ≥55 years old Drug: GVHD Prophylaxis Biological: Haplo HCT ≥55 and < 65 years old Biological: Haplo HCT ≥65 and ≤75 years old | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 84 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Reduced Intensity (RIC) Conditioning And Transplantation of HLA-Haploidentical Related Hematopoietic Cells (Haplo-HCT) For Patients With Hematologic Malignancies |
| Actual Study Start Date : | January 24, 2017 |
| Estimated Primary Completion Date : | December 2022 |
| Estimated Study Completion Date : | December 2023 |
Resource links provided by the National Library of Medicine
Genetic and Rare Diseases Information Center resources:
Multiple Myeloma
Myeloid Leukemia
Acute Myeloid Leukemia
Acute Non Lymphoblastic Leukemia
Lymphosarcoma
Mantle Cell Lymphoma
B-cell Lymphoma
Acute Lymphoblastic Leukemia
Lymphoblastic Lymphoma
Myelodysplastic Syndromes
Chronic Lymphocytic Leukemia
Primary Myelofibrosis
Chronic Myeloid Leukemia
Chronic Myeloproliferative Disorders
Follicular Lymphoma
Hodgkin Lymphoma
Burkitt Lymphoma
Waldenstrom Macroglobulinemia
Marginal Zone Lymphoma
| Arm | Intervention/treatment |
|---|---|
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Experimental: Arm A: Haplo-HCT <55 years old
Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients <55 years old with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≤2
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Biological: Haplo HCT <55 years old
Other Name: HLA-haploidentical related hematopoietic cells transplant Drug: GVHD Prophylaxis
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Experimental: CLOSED Arm B: Haplo-HCT ≥55 years old
Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients ≥55 years old or younger with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≥3.
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Biological: Haplo HCT ≥55 years old
Other Name: HLA-haploidentical related hematopoietic cells transplant Drug: GVHD Prophylaxis
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Experimental: Arm C: Haplo-HCT HCT-CI ≤2 aged ≥55 and < 65yo
Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≤2 aged ≥55 and < 65 years old.
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Drug: GVHD Prophylaxis
Biological: Haplo HCT ≥55 and < 65 years old
Other Name: HLA-haploidentical related hematopoietic cells transplant |
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Experimental: Arm D: Haplo-HCT aged ≥65 and ≤75yo OR any age HCT-CI ≥3
Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients patients ≥65 and ≤75 years old OR any age group with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≥3.
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Drug: GVHD Prophylaxis
Biological: Haplo HCT ≥65 and ≤75 years old
Other Name: HLA-haploidentical related hematopoietic cells transplant |
Primary Outcome Measures :
- Disease-free survival (DFS) [ Time Frame: 1 year ]estimate disease-free survival (DFS) at 1 year post-transplant
Secondary Outcome Measures :
- Incidence of grade II-IV and grade III-IV acute graft versus-host-disease (GVHD) [ Time Frame: day 100 ]
- Treatment related mortality (TRM) [ Time Frame: 6 month, 1 and 2 year ]
- Relapse incidence [ Time Frame: 1 and 2 year ]
- Incidence of serious fungal and viral infection [ Time Frame: at day 100 and 1 year ]post-HCT
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| Ages Eligible for Study: | up to 75 Years (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- < 70 years with an available 5-6/6 HLA-A, B, DRB1 matched sibling donor
- Pregnancy or breastfeeding
- 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).
- CML in blast crisis
- 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:
- 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.
- 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02988466
Contacts
| Contact: Timothy Krepski | 612-273-2800 | tkrepsk1@fairview.org |
Locations
| United States, Minnesota | |
| Masonic Cancer Center at University of Minnesota | Recruiting |
| Minneapolis, Minnesota, United States, 55455 | |
| Contact: Tim Krepski 612-273-2800 tkrepsk1@fairview.org | |
Sponsors and Collaborators
Masonic Cancer Center, University of Minnesota
Investigators
| Principal Investigator: | Najla El Jurdi, MD | Masonic Cancer Center, University of Minnesota |
| Responsible Party: | Masonic Cancer Center, University of Minnesota |
| ClinicalTrials.gov Identifier: | NCT02988466 |
| Other Study ID Numbers: |
2016LS092 MT2016-15 ( Other Identifier: University of Minnesota Blood and Marrow Transplant Program ) |
| First Posted: | December 9, 2016 Key Record Dates |
| Last Update Posted: | February 28, 2022 |
| Last Verified: | February 2022 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Masonic Cancer Center, University of Minnesota:
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Acute Leukemias Acute myeloid leukemia (AML) Acute lymphoblastic leukemia (ALL)/lymphoma Biphenotypic/Undifferentiated/Prolymphocytic Leukemias Myelodysplastic syndrome Chronic myelogenous leukemia Minimal Residual Disease (MRD) positive leukemia Leukemia or Myelodysplastic Syndromes (MDS) in aplasia Myeloproliferative neoplasms/myelofibrosis |
Relapsed large-cell lymphoma, mantle-cell lymphoma and Hodgkin lymphoma Burkitt's lymphoma Relapsed T-cell lymphoma Natural Killer cell malignancies Relapsed chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), marginal zone B-cell lymphoma, follicular lymphoma Lymphoplasmacytic lymphoma Relapsed multiple myeloma Bone marrow failure syndromes |
Additional relevant MeSH terms:
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Neoplasms Hematologic Neoplasms Neoplasms by Site Hematologic Diseases |