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Trial record 1 of 1 for:    00534118
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Donor Lymphocyte Infusion in Treating Patients With Recurrent or Persistent Hematologic Cancer After Donor Stem Cell Transplant

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ClinicalTrials.gov Identifier: NCT00534118
Recruitment Status : Completed
First Posted : September 24, 2007
Results First Posted : August 26, 2020
Last Update Posted : August 26, 2020
Sponsor:
Information provided by (Responsible Party):
Roswell Park Cancer Institute

Tracking Information
First Submitted Date  ICMJE September 20, 2007
First Posted Date  ICMJE September 24, 2007
Results First Submitted Date  ICMJE July 29, 2020
Results First Posted Date  ICMJE August 26, 2020
Last Update Posted Date August 26, 2020
Actual Study Start Date  ICMJE October 1, 2003
Actual Primary Completion Date July 26, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 21, 2020)
  • Complete Remission Rate [ Time Frame: 100 days post DLI ]
    continued or induced complete remission after DLI
  • Duration of Complete Response in Months (Maximum 12) [ Time Frame: 1 year post DLI ]
    For participants who achieve a complete remission after DLI, the duration of time until 1) relapse or 2) death in remission or 3) subsequent DLI or 4) last followup (at 1 year after DLI)
Original Primary Outcome Measures  ICMJE
 (submitted: September 20, 2007)
  • Response rate
  • Percent of complete responses
  • Duration of response
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 21, 2020)
Acute Graft-versus-host Disease [ Time Frame: 100 days post DLI ]
development of grade III-IV acute graft-versus-host disease (GVHD) per Glucksberg criteria
Original Secondary Outcome Measures  ICMJE
 (submitted: September 20, 2007)
Toxicity
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Donor Lymphocyte Infusion in Treating Patients With Recurrent or Persistent Hematologic Cancer After Donor Stem Cell Transplant
Official Title  ICMJE Cellular Infusions in Patients With Recurrent or Persistent Hematologic Malignancies After Allogeneic Stem Cell Transplant
Brief Summary

RATIONALE: Giving an infusion of donor lymphocytes may be able to kill cancer cells in patients with hematologic cancer that has come back after a donor stem cell transplant.

PURPOSE: This clinical trial is studying how well donor lymphocyte infusion works in treating patients with recurrent or persistent hematologic cancer after donor stem cell transplant.

Detailed Description

OBJECTIVES:

Primary

  • Determine if the complete response rate exceeds 10% in patients with recurrent or persistent hematologic malignancies treated with donor lymphocyte infusion.

Secondary

  • Estimate the complete response rate in these patients.
  • Assess the toxicity of donor lymphocyte infusion in these patients.

OUTLINE: Patients receive up to four donor lymphocyte infusions at least 1 month apart in the absence of disease progression, unacceptable toxicity, or uncontrolled graft-versus-host disease.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Leukemia
  • Lymphoma
  • Multiple Myeloma and Plasma Cell Neoplasm
  • Myelodysplastic Syndromes
Intervention  ICMJE Biological: donor lymphocytes
Given IV
Study Arms  ICMJE Experimental: Infusion
Patients receive up to four donor lymphocyte infusions at least 1 month apart in the absence of disease progression, unacceptable toxicity, or uncontrolled graft-versus-host disease
Intervention: Biological: donor lymphocytes
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 27, 2013)
39
Original Enrollment  ICMJE
 (submitted: September 20, 2007)
50
Actual Study Completion Date  ICMJE July 26, 2018
Actual Primary Completion Date July 26, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

DISEASE CHARACTERISTICS:

  • Has undergone allogeneic stem cell transplantation (ASCT) for hematologic malignancy at least 30 days ago

    • No failure to engraft following transplant
    • No active acute or chronic graft-versus-host disease (GVHD)

      • Minimal GVHD allowed
  • Persistent or relapsed disease after ASCT, including 1 of the following:

    • Chronic myelogenous leukemia (CML), meeting any of the following criteria:

      • Molecular relapse (may be treated with imatinib mesylate after transplant), as defined by any of the following:

        • ASCT was non-T-cell depleted, a negative bcr/abl was documented by PCR post-transplant, and bcr/abl is now detectable by 2 consecutive PCR determinations > 30 days apart
        • ASCT was non-T-cell depleted and bcr/abl is detectable by PCR at any time after day 180 post-transplant
      • Cytogenetic relapse after 3-6 months of imatinib mesylate
      • Relapsed chronic phase, accelerated phase, or blastic phase CML after 3-6 months of imatinib mesylate

        • Must currently be in chronic phase or accelerated phase CML only
        • Patients with blastic phase CML must attain a second chronic phase
    • Acute myeloid leukemia, acute lymphoblastic leukemia, or myelodysplastic syndromes, meeting any of the following criteria:

      • Molecular relapse, as evidenced by < 5% blasts in the bone marrow and the patient's leukemia-specific molecular abnormality detectable by PCR
      • Cytogenetic relapse, as evidenced by < 5% blasts in the bone marrow and the patient's leukemia-specific chromosome abnormality detectable by standard cytogenetics at any time after day 60 post-transplant
      • Hematologic relapse, as evidenced by > 20% blasts in bone marrow or soft tissue recurrence

        • Must be treated with chemotherapy after transplant, but before study donor lymphocyte infusion (DLI)
    • Multiple myeloma

      • Relapsed disease or recurrence of M-protein after thalidomide or other salvage treatment

        • Prior post-transplant documentation of disappearance of M-protein by immunofixation
      • Residual or progressive disease
      • Rising M-protein level at any time post-transplant (measured at 3-month intervals)
      • Original M-protein detectable at 6 months post-transplant
      • Immune protein electrophoresis (IPEP) is required to show that M-component is the same on day 60 post-transplant as pre-transplant
      • Residual (> 5%) plasma cells in bone marrow
    • Relapsed non-Hodgkin lymphoma or Hodgkin lymphoma

      • Relapse or progression of disease must be evidenced within 3 months prior to donor lymphocyte infusion by physical exam, radiographic studies, or molecular studies

        • Tumor should be re-biopsied to determine histology
      • If Epstein-Barr virus (EBV) lymphoma is suspected, peripheral blood must be assayed for EBV genome (i.e., EBV DNA testing by PCR) within the past 30 days
    • EBV infection with associated pancytopenia

      • Persistent or refractory pancytopenia with EBV genome detected by PCR in the peripheral blood

        • Refractory pancytopenia is defined as pancytopenia that is poorly responsive to growth factors and/or transfusions
    • EBV lymphoproliferative disorder

      • Clonal lymphadenopathy that is refractory to standard therapy with acyclovir and immunoglobulin (DLI may be given with rituximab)
  • Not a candidate for repeat ASCT

    • Chimerism status is not required for determining eligibility for DLI
  • Patients eligible for allogeneic ASCT, but for whom DLI is offered as the first option, should have full donor chimerism at relapse or after therapy for relapsed disease
  • Patients with relapsed underlying disease after transplant who achieved remission after chemotherapy are allowed
  • No CNS recurrence that is not cleared by standard chemotherapy

    • CNS remission status must be maintained for 2 weeks
  • Original hematopoietic progenitor stem cell donor must be available for cell donation

    • No syngeneic donors

PATIENT CHARACTERISTICS:

  • Karnofsky performance status 60-100%
  • Life expectancy ≥ 8 weeks
  • Creatinine < 3 mg/dL
  • ABO/Rh and CMV IgG/IgM status known
  • No HIV1 and HIV2 antibody
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3 months (males) or 6 months (females) after completion of study treatment

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 76 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00534118
Other Study ID Numbers  ICMJE CDR0000564827
RPCI-I-00703
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Roswell Park Cancer Institute
Study Sponsor  ICMJE Roswell Park Cancer Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Philip L. McCarthy, MD Roswell Park Cancer Institute
PRS Account Roswell Park Cancer Institute
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP