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NCT02581007 · REGISTRY CONDITION SEARCH

Reduced Intensity Conditioning Transplant Using Haploidentical Donors

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE2
Status at capture
COMPLETED
Registry last update
2023-04-27

This trial will evaluate the safety and efficacy of a reduced intensity allogeneic HSCT from partially HLA-mismatched first-degree relatives utilizing PBSC as the stem cell source. The primary objective of the study is to estimate the incidence of graft rejection and acute GVHD. A secondary objective will be to estimate the incidence of the relapse, NRM, OS, chronic GVHD and EFS.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Graft Rejection

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outcome · POSTED

Overall Survival

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outcome · POSTED

Relapse Incidence

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outcome · POSTED

GVHD Incidence

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
Inclusion Criteria: * No available matched related or unrelated donor, OR a matched related or unrelated donor will not be available in time frame necessary to perform potentially curative transplant * Availability of 3/6 - 5/6 matched (HLA-A, B, DR) related donor (donor must have negative HLA cross-match in host vs. graft direction) * Karnofsky status ≥70% * One of the following high-risk malignancies: 1. Chronic Myelogenous Leukemia: Chronic myelogenous leukemia in chronic phase, resistant or intolerant to available tyrosine kinase inhibitors; Chronic myelogenous leukemia in accelerated phase; Chronic myelogenous leukemia with blast crisis that has entered into a second chronic phase following induction chemotherapy 2. Acute Myelogenous Leukemia in first or greater remission 3. Myelodysplastic Syndrome at least one of the following: treatment-related; monosmy 7, complex cytogenetics or other high risk karyotype; IPSS score of 1.0 or greater; neutropenia or cytopenia requiring transfusion not responding to therapy; peripheral or BM blast count of \<10%; CMML 4. Acute lymphocytic leukemia/lymphoblastic lymphoma: 2nd or subsequent complete remission; first complete remission; marrow blasts \<5%, but persistence of minimal residual disease by flow cytometry, cytogenetics, or FISH 5. Chronic Lymphocytic Leukemia/Prolymphocytic Leukemia: previously treated disease that has either relapsed or failed to respond adequately to conventional-dose therapy including purine analogs 6. Hodgkin's or Non-Hodgkin's Lymphoma (including low-grade, mantle cell, and intermediate-grade/diffuse): previously treated disease that has either relapsed or failed to respond adequately to conventional-dose therapy or autologous transplantation 7. Myeloproliferative diseases (myelofibrosis, CMML) 8. Multiple Myeloma with relapse after a prior autologous transplant or eligible for allogeneic HSCT based on other risk factors Exclusion Criteria: * not be excluded on basis of sex, racial, or ethnic backgrounds * poor cardiac function: left ventricular ejection fraction \<40% * poor pulmonary function: FEV1 and FVC \<50% predicted * poor liver function: bilirubin \>2 mg/dl (not due to hemolysis, Gilbert's or primary malignancy) * poor renal function: Creatinine \>2.0mg/dl or creatinine clearance (calculated creatinine clearance is permitted) \< 40 mL/min based on Traditional Cockcroft-Gault formula: 140 - age (yrs) x Smaller of Actual Weight vs. Ideal Body Weight (kg) / 72 x Serum creatinine (mg/dl) * HIV-positive * prior allogeneic transplant * women of childbearing potential who currently are pregnant or who are not practicing adequate contraception * any debilitating medical or psychiatric illness which would preclude their giving informed consent or their receiving optimal treatment and follow-up
healthy Volunteers
false
maximum Age
75 Years
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Fludarabine, Melphalan \& Post-transplant cyclophosphamide
    intervention Names
    1. Drug: Fludarabine
    2. Drug: Melphalan
    3. Drug: Cyclophosphamide
    4. Procedure: peripheral blood stem cell transplant
    label
    Reduced-Intensity Mismatched Transplant
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Reduced-Intensity Mismatched Transplant
    description
    fludarabine (30mg/m2) given every day starting on Day -6 through Day -2;
    name
    Fludarabine
    other Names
    1. Fludara
    type
    DRUG
  2. arm Group Labels
    1. Reduced-Intensity Mismatched Transplant
    name
    Melphalan
    other Names
    1. melphalan (140mg/m2) given one time on Day -1.
    type
    DRUG
  3. arm Group Labels
    1. Reduced-Intensity Mismatched Transplant
    description
    cyclophosphamide (50mg/kg) given every day starting on Day 3 through Day 4.
    name
    Cyclophosphamide
    other Names
    1. Cytoxan
    type
    DRUG
  4. arm Group Labels
    1. Reduced-Intensity Mismatched Transplant
    name
    peripheral blood stem cell transplant
    other Names
    1. HSCT
    type
    PROCEDURE
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
25
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Measurement of donor cells vs. recipient cells
    measure
    Graft Rejection
    time Frame
    100 days
secondary Outcomes
  1. description
    Number of participants still alive 2 years after transplant
    measure
    Overall Survival
    time Frame
    2 years
  2. description
    Number of patients with disease reoccurrence at 1 and 2 years post-transplant
    measure
    Relapse Incidence
    time Frame
    2 years
  3. description
    The number of participants that developed graft-versus-host-disease before or at 100 days after transplant
    measure
    GVHD Incidence
    time Frame
    100 days
Full study description
brief Summary
This trial will evaluate the safety and efficacy of a reduced intensity allogeneic HSCT from partially HLA-mismatched first-degree relatives utilizing PBSC as the stem cell source. The primary objective of the study is to estimate the incidence of graft rejection and acute GVHD. A secondary objective will be to estimate the incidence of the relapse, NRM, OS, chronic GVHD and EFS.
detailed Description
Patients will receive a haploidentical transpalnt using a fludarabine melphalan prepartive regimen. Patients will get cyclophosphamide on days 3 \& 4 post-transplant.
Source references
references
  1. citation
    Szydlo R, Goldman JM, Klein JP, Gale RP, Ash RC, Bach FH, Bradley BA, Casper JT, Flomenberg N, Gajewski JL, Gluckman E, Henslee-Downey PJ, Hows JM, Jacobsen N, Kolb HJ, Lowenberg B, Masaoka T, Rowlings PA, Sondel PM, van Bekkum DW, van Rood JJ, Vowels MR, Zhang MJ, Horowitz MM. Results of allogeneic bone marrow transplants for leukemia using donors other than HLA-identical siblings. J Clin Oncol. 1997 May;15(5):1767-77. doi: 10.1200/JCO.1997.15.5.1767.
    pmid
    9164184
    type
    BACKGROUND
  2. citation
    Anasetti C, Amos D, Beatty PG, Appelbaum FR, Bensinger W, Buckner CD, Clift R, Doney K, Martin PJ, Mickelson E, et al. Effect of HLA compatibility on engraftment of bone marrow transplants in patients with leukemia or lymphoma. N Engl J Med. 1989 Jan 26;320(4):197-204. doi: 10.1056/NEJM198901263200401.
    pmid
    2643045
    type
    BACKGROUND
  3. citation
    Kernan NA, Flomenberg N, Dupont B, O'Reilly RJ. Graft rejection in recipients of T-cell-depleted HLA-nonidentical marrow transplants for leukemia. Identification of host-derived antidonor allocytotoxic T lymphocytes. Transplantation. 1987 Jun;43(6):842-7.
    pmid
    3296349
    type
    BACKGROUND
  4. citation
    Aversa F, Terenzi A, Tabilio A, Falzetti F, Carotti A, Ballanti S, Felicini R, Falcinelli F, Velardi A, Ruggeri L, Aloisi T, Saab JP, Santucci A, Perruccio K, Martelli MP, Mecucci C, Reisner Y, Martelli MF. Full haplotype-mismatched hematopoietic stem-cell transplantation: a phase II study in patients with acute leukemia at high risk of relapse. J Clin Oncol. 2005 May 20;23(15):3447-54. doi: 10.1200/JCO.2005.09.117. Epub 2005 Mar 7.
    pmid
    15753458
    type
    BACKGROUND
  5. citation
    Bashey A, Solomon SR. T-cell replete haploidentical donor transplantation using post-transplant CY: an emerging standard-of-care option for patients who lack an HLA-identical sibling donor. Bone Marrow Transplant. 2014 Aug;49(8):999-1008. doi: 10.1038/bmt.2014.62. Epub 2014 May 19.
    pmid
    24842530
    type
    BACKGROUND
  6. citation
    O'Donnell PV, Luznik L, Jones RJ, Vogelsang GB, Leffell MS, Phelps M, Rhubart P, Cowan K, Piantados S, Fuchs EJ. Nonmyeloablative bone marrow transplantation from partially HLA-mismatched related donors using posttransplantation cyclophosphamide. Biol Blood Marrow Transplant. 2002;8(7):377-86. doi: 10.1053/bbmt.2002.v8.pm12171484.
    pmid
    12171484
    type
    BACKGROUND
  7. citation
    Solomon SR, Sizemore CA, Sanacore M, Zhang X, Brown S, Holland HK, Morris LE, Bashey A. Haploidentical transplantation using T cell replete peripheral blood stem cells and myeloablative conditioning in patients with high-risk hematologic malignancies who lack conventional donors is well tolerated and produces excellent relapse-free survival: results of a prospective phase II trial. Biol Blood Marrow Transplant. 2012 Dec;18(12):1859-66. doi: 10.1016/j.bbmt.2012.06.019. Epub 2012 Aug 1.
    pmid
    22863841
    type
    BACKGROUND
  8. citation
    Solomon SR, Sizemore CA, Sanacore M, Zhang X, Brown S, Holland HK, Morris LE, Bashey A. Total Body Irradiation-Based Myeloablative Haploidentical Stem Cell Transplantation Is a Safe and Effective Alternative to Unrelated Donor Transplantation in Patients Without Matched Sibling Donors. Biol Blood Marrow Transplant. 2015 Jul;21(7):1299-307. doi: 10.1016/j.bbmt.2015.03.003. Epub 2015 Mar 19.
    pmid
    25797174
    type
    BACKGROUND
Source notices and limitations
    Discovery and provenance
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    Preserved source evidence · Not medical advice