- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02988466
Reduced Intensity (RIC) Conditioning And Transplantation of HLA-Haplo-HCT
May 5, 2023 updated by: Masonic Cancer Center, University of Minnesota
Reduced Intensity (RIC) Conditioning And Transplantation of HLA-Haploidentical Related Hematopoietic Cells (Haplo-HCT) For Patients With Hematologic Malignancies
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
Study Overview
Status
Active, not recruiting
Conditions
Study Type
Interventional
Enrollment (Actual)
78
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Timothy Krepski
- Phone Number: 612-273-2800
- Email: tkrepsk1@fairview.org
Study Locations
-
-
Minnesota
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Minneapolis, Minnesota, United States, 55455
- Masonic Cancer Center at University of Minnesota
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 75 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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
|
Other Names:
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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.
|
Other Names:
|
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.
|
Other Names:
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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.
|
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Disease-free survival (DFS)
Time Frame: 1 year
|
estimate disease-free survival (DFS) at 1 year post-transplant
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of grade II-IV and grade III-IV acute graft versus-host-disease (GVHD)
Time Frame: day 100
|
day 100
|
|
Treatment related mortality (TRM)
Time Frame: 6 month, 1 and 2 year
|
6 month, 1 and 2 year
|
|
Relapse incidence
Time Frame: 1 and 2 year
|
1 and 2 year
|
|
Incidence of serious fungal and viral infection
Time Frame: at day 100 and 1 year
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post-HCT
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at day 100 and 1 year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Najla El Jurdi, MD, Masonic Cancer Center, University of Minnesota
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 24, 2017
Primary Completion (Actual)
May 2, 2023
Study Completion (Anticipated)
December 1, 2024
Study Registration Dates
First Submitted
December 7, 2016
First Submitted That Met QC Criteria
December 8, 2016
First Posted (Estimate)
December 9, 2016
Study Record Updates
Last Update Posted (Actual)
May 8, 2023
Last Update Submitted That Met QC Criteria
May 5, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Keywords
- Burkitt's lymphoma
- Chronic myelogenous leukemia
- Myelodysplastic syndrome
- Lymphoplasmacytic lymphoma
- Bone marrow failure syndromes
- Acute myeloid leukemia (AML)
- Relapsed multiple myeloma
- Acute Leukemias
- Acute lymphoblastic leukemia (ALL)/lymphoma
- Biphenotypic/Undifferentiated/Prolymphocytic Leukemias
- 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
- Relapsed T-cell lymphoma
- Natural Killer cell malignancies
- Relapsed chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), marginal zone B-cell lymphoma, follicular lymphoma
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016LS092
- MT2016-15 (Other Identifier: University of Minnesota Blood and Marrow Transplant Program)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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