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Status:

COMPLETED

Laboratory-Treated Lymphocyte Infusion After Haploidentical Donor Stem Cell Transplant

Lead Sponsor:

Dana-Farber Cancer Institute

Collaborating Sponsors:

National Cancer Institute (NCI)

National Institute of Allergy and Infectious Diseases (NIAID)

Conditions:

Leukemia

Myelodysplastic Syndromes

Eligibility:

All Genders

Up to 50 years

Phase:

PHASE1

Brief Summary

RATIONALE: Giving total-body irradiation and chemotherapy, such as thiotepa and fludarabine, before a donor stem cell transplant helps stop the growth of cancer or abnormal cells. It also helps stop t...

Detailed Description

OBJECTIVES: Primary * Establish the feasibility of delayed infusion of ex vivo anergized donor peripheral blood mononuclear cells (PBMC) after CD34 (cluster designation 34)-selected megadose haploid...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Diagnosis of 1 of the following:
  • Acute lymphocytic leukemia
  • In ≥ second complete remission (CR), defined as \< 5% blasts in bone marrow (BM) and no active extramedullary disease OR in first CR with any of the following high risk features:
  • History of induction failure
  • Philadelphia chromosome positive
  • t(4;11) by cytogenetic analysis
  • Any infant with MLL rearrangements on cytogenetic analysis
  • No relapse with isolated extramedullary disease after completion of prior treatment
  • Acute myeloid leukemia
  • Failed induction therapy after \< 3 courses
  • In ≥ second CR, defined as \< 5% blasts in BM and no active extramedullary disease OR in first CR with any of the following high-risk features:
  • History of induction failure = 5q- or monosomy 7 cytogenetic findings
  • Any of the following myelodysplastic syndromes:
  • Refractory anemia (RA) with excess blasts (RAEB) with a high International Prognostic Scoring System (IPSS) score or score of intermediate-1(INT-1) or intermediate-2 (INT-2)
  • RAEB in transformation with INT-1, INT-2, or high IPSS score
  • RA with INT-2 score
  • Patients must have a healthy, related donor who is at least genotypically HLA-A, B, C, and DR haploidentical to the patient
  • No suitably matched family donor defined by genotypic or phenotypic identity for ≥ 5/6 A, B, or DR loci
  • No immediately available genotypically matched (6/6) unrelated marrow donor
  • No immediately available umbilical cord blood donor with suitable cell dose after a search ≥ 2 months
  • Patients whose medical condition is at high risk of deteriorating or whose disease is at high risk of progression during a donor search are eligible
  • Has a parent with a haplotype that is disparate from that of the donor for the haplotype shared by the patient and parent, but not shared by the patient and donor OR patient is able to donate sufficient autologous cells by peripheral blood draw or unstimulated leukapheresis
  • No active CNS disease
  • PATIENT CHARACTERISTICS:
  • Room air O\_2 saturation \> 95% unless the lungs are involved with disease
  • No clinical evidence of pulmonary insufficiency unless the lungs are involved with disease
  • AST and ALT \< 3 times upper limit of normal (ULN)\*
  • Bilirubin \< 2.0 mg/dL\*
  • Creatinine \< 2 times ULN OR creatinine clearance or glomerular filtration rate \> 50% of the lower limit of normal
  • LVEF \> 45% OR shortening fraction \> 20%
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No active infection, defined as absence of an infectious diagnosis or (in patients who have had a recent positive infectious diagnosis) the resolution of fever, documentation of negative cultures or antigen testing, continuation or completion of a course of appropriate therapy, and presence of stable to resolving clinical symptoms
  • No evidence of HIV infection OR known HIV positivity NOTE: \*Does not apply if liver is involved with disease
  • PRIOR CONCURRENT THERAPY:
  • See Disease Characteristics
  • No prior stem cell transplantation
  • No other concurrent immunosuppressive therapy

Exclusion

    Key Trial Info

    Start Date :

    June 1 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    May 16 2018

    Estimated Enrollment :

    19 Patients enrolled

    Trial Details

    Trial ID

    NCT00376480

    Start Date

    June 1 2005

    End Date

    May 16 2018

    Last Update

    July 5 2019

    Active Locations (6)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 2 (6 locations)

    1

    Childrens Hospital Los Angeles

    Los Angeles, California, United States, 90027-0700

    2

    University of Florida Health Science Center - Gainesville

    Gainesville, Florida, United States, 32610

    3

    Massachusetts General Hospital

    Boston, Massachusetts, United States, 02114

    4

    Children's Hospital Boston

    Boston, Massachusetts, United States, 02115