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

Lymphoma Clinical Trial

Official title:

Cellular Infusions in Patients With Recurrent or Persistent Hematologic Malignancies After Allogeneic Stem Cell Transplant

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00534118
• Other study ID #: CDR0000564827
• Secondary ID: RPCI-I-00703
• Status: Completed
• Phase: N/A
• Start date: October 1, 2003
• Est. completion date: July 26, 2018

Study information

• Verified date: August 2020
• Source: Roswell Park Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: July 26, 2018
• Est. primary completion date: July 26, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 76 Years

Eligibility

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

Related Conditions & MeSH terms

• Leukemia
• Lymphoma
• Multiple Myeloma
• Multiple Myeloma and Plasma Cell Neoplasm
• Myelodysplastic Syndromes
• Neoplasms, Plasma Cell
• Preleukemia
• Syndrome

Intervention

Biological:
• donor lymphocytes
Given IV

Locations

Country	Name	City	State
United States	Roswell Park Cancer Institute	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
Roswell Park Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete Remission Rate	continued or induced complete remission after DLI	100 days post DLI
Primary	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	Acute Graft-versus-host Disease	development of grade III-IV acute graft-versus-host disease (GVHD) per Glucksberg criteria	100 days post DLI