Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Donor Lymphocyte Infusion in Treating Patients With Recurrent or Persistent Hematologic Cancer After Donor Stem Cell Transplant

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Roswell Park Cancer Institute Identifier:
First received: September 20, 2007
Last updated: January 5, 2015
Last verified: January 2015

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.

Condition Intervention
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Biological: donor lymphocytes

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Cellular Infusions in Patients With Recurrent or Persistent Hematologic Malignancies After Allogeneic Stem Cell Transplant

Resource links provided by NLM:

Further study details as provided by Roswell Park Cancer Institute:

Primary Outcome Measures:
  • Determine if response rate exceeds 10% [ Time Frame: Every 2 weeks ] [ Designated as safety issue: No ]
  • Estimate the complete Response rate [ Time Frame: Every 2 weeks ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: Every 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assess toxicity of cellular therapy [ Time Frame: Every 2 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 39
Study Start Date: October 2003
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Biological: donor lymphocytes
Given IV

Detailed Description:



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


  • 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.


Ages Eligible for Study:   up to 76 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No


  • 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


  • 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


  • See Disease Characteristics
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00534118

United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Sponsors and Collaborators
Roswell Park Cancer Institute
Principal Investigator: Philip L. McCarthy, MD Roswell Park Cancer Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Roswell Park Cancer Institute Identifier: NCT00534118     History of Changes
Other Study ID Numbers: CDR0000564827, RPCI-I-00703
Study First Received: September 20, 2007
Last Updated: January 5, 2015
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Roswell Park Cancer Institute:
accelerated phase chronic myelogenous leukemia
chronic phase chronic myelogenous leukemia
relapsing chronic myelogenous leukemia
childhood chronic myelogenous leukemia
previously treated myelodysplastic syndromes
recurrent adult acute lymphoblastic leukemia
recurrent childhood acute lymphoblastic leukemia
adult acute myeloid leukemia with 11q23 (MLL) abnormalities
adult acute myeloid leukemia with inv(16)(p13;q22)
adult acute myeloid leukemia with t(15;17)(q22;q12)
adult acute myeloid leukemia with t(16;16)(p13;q22)
adult acute myeloid leukemia with t(8;21)(q22;q22)
recurrent adult acute myeloid leukemia
recurrent childhood acute myeloid leukemia
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma
refractory multiple myeloma
recurrent adult Hodgkin lymphoma
recurrent/refractory childhood Hodgkin lymphoma
recurrent adult Burkitt lymphoma
recurrent adult diffuse large cell lymphoma
recurrent adult diffuse mixed cell lymphoma
recurrent adult diffuse small cleaved cell lymphoma
recurrent adult immunoblastic large cell lymphoma
recurrent adult lymphoblastic lymphoma
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
recurrent grade 3 follicular lymphoma
recurrent mantle cell lymphoma

Additional relevant MeSH terms:
Multiple Myeloma
Myelodysplastic Syndromes
Neoplasms, Plasma Cell
Blood Protein Disorders
Bone Marrow Diseases
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms by Histologic Type
Pathologic Processes
Precancerous Conditions
Vascular Diseases processed this record on February 25, 2015