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| ID | Type | Description | Link |
|---|---|---|---|
| RPCI-I-00703 |
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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.
OBJECTIVES:
Primary
Secondary
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| donor lymphocytes | Biological | Given IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Acute Graft-versus-host Disease | development of grade III-IV acute graft-versus-host disease (GVHD) per Glucksberg criteria | 100 days post DLI |
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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)
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:
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
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
Multiple myeloma
Relapsed disease or recurrence of M-protein after thalidomide or other salvage treatment
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
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
EBV lymphoproliferative disorder
Not a candidate for repeat ASCT
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
Original hematopoietic progenitor stem cell donor must be available for cell donation
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Philip L. McCarthy, MD | Roswell Park Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Roswell Park Cancer Institute | Buffalo | New York | 14263-0001 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Multiple DLI | Accruals where the patient received 2-4 donor lymphocyte infusions Arm includes total number of infusions |
| FG001 | Single DLI | accruals where the patient received only one donor lymphocyte infusion |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 7, 2017 |
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| COMPLETED |
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| NOT COMPLETED |
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Participants can be accrued more than once; Accruals are based on the number of times the participant had a treatment (DLI) cycle that was evaluable (ie. >8 weeks between infusions per the protocol). DLIs which were given <8 weeks apart counted as one accrual.
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| ID | Title | Description |
|---|---|---|
| BG000 | Multiple DLI | Accruals where the patient received 2-4 donor lymphocyte infusions Arm includes total number of infusions |
| BG001 | Single DLI | Accruals where the patient received only one donor lymphocyte infusion |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Median | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| Disease | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Complete Remission Rate | continued or induced complete remission after DLI | Each accrual is evaluable independently, some patients in both the Multiple and Single DLI are accrued more than once; total unique patients in multiple DLI is 15 and in single DLI is 12 | Posted | Count of Participants | Participants | 100 days post DLI |
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| 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) | Accruals which achieved a continued or induced complete remission at Day +100 after DLI, patients are censored at death in remission or at time of subsequent DLI | Posted | Median | Full Range | months | 1 year post DLI |
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| Secondary | Acute Graft-versus-host Disease | development of grade III-IV acute graft-versus-host disease (GVHD) per Glucksberg criteria | Each accrual is evaluable for acute GVHD grade III-IV | Posted | Count of Participants | Participants | 100 days post DLI |
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All cause mortality includes individual participants who experienced death due to any cause before 3 years after first DLI and is the only SAE/AE captured per protocol
All cause mortality includes individual participants who experienced death due to any cause before 3 years after first DLI
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Multiple DLI | Accruals where the patient received 2-4 donor lymphocyte infusions Arm includes total number of infusions | 10 | 15 | 10 | 15 | 0 | 15 |
| EG001 | Single DLI | accruals where the patient received only one donor lymphocyte infusion | 7 | 12 | 7 | 12 | 0 | 12 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| All cause mortality by 3 years after first DLI | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Theresa Hahn | Roswell Park Cancer Institute | 716-845-2300 | theresa.hahn@roswellpark.org |
| Jul 29, 2020 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D007938 | Leukemia |
| D008223 | Lymphoma |
| D009101 | Multiple Myeloma |
| D054219 | Neoplasms, Plasma Cell |
| D009190 | Myelodysplastic Syndromes |
| D015465 | Leukemia, Myeloid, Accelerated Phase |
| D015466 | Leukemia, Myeloid, Chronic-Phase |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D000013 | Congenital Abnormalities |
| D015470 | Leukemia, Myeloid, Acute |
| D006689 | Hodgkin Disease |
| D012008 | Recurrence |
| D002051 | Burkitt Lymphoma |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D008228 | Lymphoma, Non-Hodgkin |
| D016400 | Lymphoma, Large-Cell, Immunoblastic |
| D008224 | Lymphoma, Follicular |
| D020522 | Lymphoma, Mantle-Cell |
| D018442 | Lymphoma, B-Cell, Marginal Zone |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D008258 | Waldenstrom Macroglobulinemia |
| D054739 | Dendritic Cell Sarcoma, Interdigitating |
| D016410 | Lymphoma, T-Cell, Cutaneous |
| D009182 | Mycosis Fungoides |
| D012751 | Sezary Syndrome |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D001855 | Bone Marrow Diseases |
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| D007951 | Leukemia, Myeloid |
| D009196 | Myeloproliferative Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007945 | Leukemia, Lymphoid |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D020031 | Epstein-Barr Virus Infections |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D014412 | Tumor Virus Infections |
| D016393 | Lymphoma, B-Cell |
| D015448 | Leukemia, B-Cell |
| D015620 | Histiocytic Disorders, Malignant |
| D015614 | Histiocytosis |
| D016399 | Lymphoma, T-Cell |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Myelodysplastic Syndrome |
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| Non Hodgkin Leukemia |
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| Acute Lymphoblastic Leukemia |
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| Chronic Myeloid Leukemia |
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| Hodgkin Lymphoma |
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| Prolymphocytic Leukemia |
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