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

NCT00534118 | Completed Results DMC

• 2 other identifiers: CDR0000564827RPCI-I-00703
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Leukemia; Lymphoma; Multiple Myeloma and Plasma Cell Neoplasm; Myelodysplastic Syndromes

Keywords

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; recurrent marginal zone lymphoma; recurrent small lymphocytic lymphoma; recurrent adult grade III lymphomatoid granulomatosis; Waldenstrom macroglobulinemia; recurrent childhood grade III lymphomatoid granulomatosis; recurrent childhood large cell lymphoma; recurrent childhood lymphoblastic lymphoma; childhood diffuse large cell lymphoma; childhood immunoblastic large cell lymphoma; recurrent childhood small noncleaved cell lymphoma; de novo myelodysplastic syndromes; secondary acute myeloid leukemia; secondary myelodysplastic syndromes; splenic marginal zone lymphoma; extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue; nodal marginal zone B-cell lymphoma; recurrent cutaneous T-cell non-Hodgkin lymphoma; recurrent mycosis fungoides/Sezary syndrome; cutaneous B-cell non-Hodgkin lymphoma

Outcome Measures

Primary Outcomes (2)

• Complete Remission Rate

  continued or induced complete remission after DLI

  100 days post DLI

• Duration of Complete Response in Months (Maximum 12)

  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)

  1 year post DLI

Secondary Outcomes (1)

• Acute Graft-versus-host Disease

  100 days post DLI

Study Arms (1)

Infusion

EXPERIMENTAL

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

Interventions

donor lymphocytes BIOLOGICAL

Given IV

Infusion

Eligibility Criteria

• Age: Up to 76 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

MeSH Terms

Conditions

Leukemia; Lymphoma; Multiple Myeloma; Neoplasms, Plasma Cell; Myelodysplastic Syndromes; Leukemia, Myeloid, Accelerated Phase; Leukemia, Myeloid, Chronic-Phase; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Congenital Abnormalities; Leukemia, Myeloid, Acute; Hodgkin Disease; Recurrence; Burkitt Lymphoma; Lymphoma, Large B-Cell, Diffuse; Lymphoma, Non-Hodgkin; Lymphoma, Large-Cell, Immunoblastic; Lymphoma, Follicular; Lymphoma, Mantle-Cell; Lymphoma, B-Cell, Marginal Zone; Leukemia, Lymphocytic, Chronic, B-Cell; Waldenstrom Macroglobulinemia; Dendritic Cell Sarcoma, Interdigitating; Lymphoma, T-Cell, Cutaneous; Mycosis Fungoides; Sezary Syndrome

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Bone Marrow Diseases; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myeloid; Myeloproliferative Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Leukemia, Lymphoid; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Epstein-Barr Virus Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Lymphoma, B-Cell; Leukemia, B-Cell; Histiocytic Disorders, Malignant; Histiocytosis; Lymphoma, T-Cell

Results Point of Contact

• Title: Theresa Hahn
• Organization: Roswell Park Cancer Institute

theresa.hahn@roswellpark.org

716-845-2300

Study Officials

• Philip L. McCarthy, MD

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2007
• First Posted: September 24, 2007
• Study Start: October 1, 2003
• Primary Completion: July 26, 2018
• Study Completion: July 26, 2018
• Last Updated: August 26, 2020
• Results First Posted: August 26, 2020

Record last verified: 2020-08

Locations

US (1)