- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04191187
Reduced Intensity Flu/Mel/TBI Conditioning for HAPLO HCT Patients With Hematologic Malignancies
March 18, 2024 updated by: H. Lee Moffitt Cancer Center and Research Institute
Reduced-Intensity Fludarabine, Melphalan, and Total Body Irradiation Conditioning for Transplantation of HLA-Haploidentical Related Hematopoietic Cells (Haplo-HCT) For Patients With Hematologic Malignancies
This is a single arm, phase II trial of HLA-haploidentical related hematopoietic cells transplant (Haplo-HCT) using reduced intensity conditioning (fludarabine and melphalan and total body irradiation).
Peripheral blood is the donor graft source.
This study is designed to estimate disease-free survival (DFS) at 18 months post-transplant.
Study Overview
Status
Active, not recruiting
Conditions
- Acute Myeloid Leukemia
- Myelodysplastic Syndromes
- Hodgkin Lymphoma
- Burkitt Lymphoma
- Acute Lymphoblastic Leukemia
- Mantle Cell Lymphoma
- Lymphoplasmacytic Lymphoma
- Chronic Myelogenous Leukemia
- Prolymphocytic Leukemia
- Myeloproliferative Neoplasm
- Relapsed Follicular Lymphoma
- Relapsed T-Cell Lymphoma
- Relapsed Chronic Lymphocytic Leukemia
- Relapsed Small Lymphocytic Lymphoma
- Biphenotypic Acute Leukemia
- Undifferentiated Leukemia
- Relapsed Large Cell Lymphoma
- Relapsed Marginal B-cell Lymphoma
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
37
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 Locations
-
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Florida
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Tampa, Florida, United States, 33612
- H. Lee Moffitt Cancer Center & Research Institute
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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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Age ≥ 55 years or HCT Co-Morbidity score (HCT-CI) >/=3
- Lack of a suitable 8/8 HLA-matched sibling donor
- Adequate performance status is defined as Karnofsky score ≥ 70%
- Patients and selected donor must be HLA typed at high resolution using DNA based typing at the following HLA-loci: HLA-A, -B, -C and DRB1. Donors must be HLA-haploidentical relatives including, but not limited to, children, siblings, or parents, defined as having a shared HLA haplotype between donor and patient at HLA-A, -B, -C, and -DRB1.
- Acute Myeloid Leukemia (AML): Must be in remission with morphology (<5% blasts)
- Acute Lymphoblastic Leukemia (ALL)/lymphoma second or greater complete remission (CR) first CR unable to tolerate consolidation chemotherapy due to chemotherapy-related toxicities, first CR high-risk ALL
- Biphenotypic/Undifferentiated/Prolymphocytic Leukemias in first or subsequent CR
- Myelodysplastic syndrome: any subtype including refractory anemia (RA) if severe pancytopenia or complex cytogenetics. Blasts must be less than 5%. If 5% of more requires chemotherapy for cytoreduction to </=5% prior to transplantation.
- Chronic Myelogenous leukemia in accelerated phase: patient must have failed at least two different Tyrosine Kinase Inhibitor (TKI)s, been intolerant to all TKIs, or have T315l mutation
- Myeloproliferative neoplasms/myelofibrosis: Blasts must be less than 5%. If 5% or more requires chemotherapy for cytoreduction to </=5% prior to transplantation
- Relapsed large-cell lymphoma, mantle-cell lymphoma or Hodgkin lymphoma that is chemotherapy sensitive and has failed or ineligible for an autologous transplant
- Burkitt's lymphoma in second CR or subsequent CR
- Relapsed T-cell lymphoma that is chemotherapy sensitive in CR/Partial Response (PR) that has failed or ineligible for an autologous transplant
- Natural killer cell malignancies
- Relapsed chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), marginal zone B-cell lymphoma, follicular lymphoma with any of the following:
- Progressed within 12 months of achieving a partial or complete remission Patients who had remissions lasting up
- Patients who had remission lasting > 12 months are eligible after at least two prior therapies
- Patients with primary, refractory disease. Bulky disease and an estimated tumor doubling time of less than one month require debulking therapy prior to transplant.
- Lymphoplasmacytic lymphoma is eligible after initial therapy if chemotherapy sensitive
- Adequate organ function as defined per protocol
- Sexually active females of child bearing potential and males with partners of child bearing potential must agree to use adequate birth control during study treatment
Exclusion Criteria:
- Pregnant or breastfeeding
- Untreated active infection
- Active HIV infection
- Prior allogenic transplant at any time prior or less than 6 months since prior autologous transplant (if applicable)
- Active central nervous system malignancy
- Favorable risk AML defined as per protocol
- Active central nervous system malignancy
- Favorable risk AML defined as having one of the following:
- t(8,21) without cKIT mutation or evidence of immunophenotypic, cytogenetic or molecular minimal residual disease (MRD)
- inv(16) or t(16;16) without cKIT mutation or evidence of MRD
- Normal karyotype with mutated NPM1 but FLT3-ITD wild type without evidence of MRD
- Normal karyatype with double mutated CEBPA without evidence of MRD
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Conditioning Regimen + Transplant
All participants will receive a conditioning regimen of Fludarabine, Melphalan and Total Body Irradiation prior to transplantation of HLA-Haploidentical Related Hematopoietic Cells (Haplo-HCT)
|
Fludarabine 30mg/m^2/day will be administered over 30-60 minutes intravenous infusion on Days -6 through -2 for a total dose of 150 mg/m^2
Other Names:
Melphalan 70 mg/m^2 over 45 minutes will be administered Day -6.
Melphalan dose will be calculated based on Actual Body Weight.
Other Names:
Total Body Irradiation (TBI) will be delivered at a dose of 200 centigray units (cGy)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Disease Free Survival
Time Frame: Up to 18 months post-transplant
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Disease Free Survival (DFS) is defined as the time from the date of Peripheral Blood Stem Cell Transplant (PBSCT) to first documentation of relapse or death due to any cause, whichever comes first.
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Up to 18 months post-transplant
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Graft vs Host Disease (GVHD) free survival
Time Frame: At 180 days post-transplant
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GVHD-free survival is defined as the time from the date of PBSCT to date of events which include grade III-IV acute GVHD and systemic therapy-requiring chronic GVHD.
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At 180 days post-transplant
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Overall Survival (OS)
Time Frame: Up to 18 months
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OS is defined as the time from the date of PBSCT to the date of death due to any cause.
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Up to 18 months
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Treatment Related Mortality (TRM) at 6 months
Time Frame: at 6 months post-transplant
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TRM is defined as death not directly due to disease
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at 6 months post-transplant
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Treatment Related Mortality (TRM) at 18 months
Time Frame: at 18 months post-transplant
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TRM is defined as death not directly due to disease
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at 18 months post-transplant
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Relapse Free Survival (RFS)
Time Frame: Up to 18 months post-transplant
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RFS is defined as the time from the date of PBSCT to relapse or death.
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Up to 18 months post-transplant
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Nelli Bejanyan, MD, Moffitt Cancer Center
- Principal Investigator: Hany Elmariah, MD, MS, Moffitt Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
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)
December 6, 2019
Primary Completion (Actual)
February 11, 2024
Study Completion (Estimated)
February 1, 2025
Study Registration Dates
First Submitted
December 6, 2019
First Submitted That Met QC Criteria
December 6, 2019
First Posted (Actual)
December 9, 2019
Study Record Updates
Last Update Posted (Actual)
March 19, 2024
Last Update Submitted That Met QC Criteria
March 18, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Virus Diseases
- Infections
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma, Non-Hodgkin
- Neoplasms by Site
- Disease Attributes
- Bone Marrow Diseases
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- DNA Virus Infections
- Tumor Virus Infections
- Neoplasms, Plasma Cell
- Leukemia, Lymphoid
- Epstein-Barr Virus Infections
- Herpesviridae Infections
- Leukemia, B-Cell
- Lymphoma, B-Cell
- Chronic Disease
- Lymphoma
- Myelodysplastic Syndromes
- Hematologic Neoplasms
- Leukemia
- Leukemia, Myeloid
- Burkitt Lymphoma
- Lymphoma, Mantle-Cell
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Waldenstrom Macroglobulinemia
- Leukemia, Lymphocytic, Chronic, B-Cell
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
- Myeloproliferative Disorders
- Leukemia, Prolymphocytic
- Leukemia, Biphenotypic, Acute
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Melphalan
- Fludarabine
Other Study ID Numbers
- MCC-20131
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
Yes
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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