Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-25 @ 5:03 AM
NCT ID:
NCT00534118
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
76 Years
Study:
NCT00534118
Study Brief:
Protocol Section:
NCT00534118