- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01839916
Donor T Cells After Donor Stem Cell Transplant in Treating Patients With Hematologic Malignancies
Pilot Study of Prophylactic Dose-Escalation Donor Lymphocyte Infusion After T Cell Depleted Allogeneic Stem Cell Transplant in High Risk Patients With Hematologic Malignancies
Study Overview
Status
Conditions
- Recurrent Adult Acute Myeloid Leukemia
- Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
- Nodal Marginal Zone B-cell 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
- Splenic Marginal Zone Lymphoma
- Waldenström Macroglobulinemia
- Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
- Adult Acute Myeloid Leukemia With Del(5q)
- Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
- Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
- Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
- Peripheral T-cell Lymphoma
- Anaplastic Large Cell Lymphoma
- Angioimmunoblastic T-cell Lymphoma
- Accelerated Phase Chronic Myelogenous Leukemia
- Adult Nasal Type Extranodal NK/T-cell Lymphoma
- Childhood Chronic Myelogenous Leukemia
- Childhood Myelodysplastic Syndromes
- Chronic Phase Chronic Myelogenous Leukemia
- Cutaneous B-cell Non-Hodgkin Lymphoma
- Hepatosplenic T-cell Lymphoma
- Intraocular Lymphoma
- Post-transplant Lymphoproliferative Disorder
- Previously Treated Myelodysplastic Syndromes
- Recurrent Adult Acute Lymphoblastic Leukemia
- Recurrent Adult Grade III Lymphomatoid Granulomatosis
- Recurrent Adult Hodgkin Lymphoma
- Recurrent Adult T-cell Leukemia/Lymphoma
- Recurrent Childhood Acute Lymphoblastic Leukemia
- Recurrent Childhood Acute Myeloid Leukemia
- Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma
- Recurrent Mycosis Fungoides/Sezary Syndrome
- Recurrent Small Lymphocytic Lymphoma
- Relapsing Chronic Myelogenous Leukemia
- Secondary Myelodysplastic Syndromes
- Small Intestine Lymphoma
- Testicular Lymphoma
- Refractory Chronic Lymphocytic Leukemia
- Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)
- Refractory Hairy Cell Leukemia
- T-cell Large Granular Lymphocyte Leukemia
- Childhood Diffuse Large Cell Lymphoma
- Childhood Immunoblastic Large Cell Lymphoma
- Childhood Nasal Type Extranodal NK/T-cell Lymphoma
- Recurrent Childhood Anaplastic Large Cell Lymphoma
- Recurrent Childhood Grade III Lymphomatoid Granulomatosis
- Recurrent Childhood Large Cell Lymphoma
- Recurrent Childhood Lymphoblastic Lymphoma
- Recurrent Childhood Small Noncleaved Cell Lymphoma
- Recurrent/Refractory Childhood Hodgkin Lymphoma
- Childhood Burkitt Lymphoma
- de Novo Myelodysplastic Syndromes
- Blastic Phase Chronic Myelogenous Leukemia
- Noncutaneous Extranodal Lymphoma
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVES:
I. To determine the feasibility of escalating dose regimen (EDR) donor lymphocyte infusion (DLI) as measured by the proportion of patients who receive at least one DLI.
SECONDARY OBJECTIVES:
I. To assess progression free survival (PFS) at 2 years after stem cell transplant (SCT) for high-risk hematologic malignancies receiving T-cell depleted grafts followed by escalating dose regimen (EDR) prophylactic DLI compared to historical controls not receiving DLI.
II. To assess the safety of EDR DLI for high-risk hematologic malignancies as measured by cumulative incidence of severe grade III-IV acute graft-versus-host disease (GVHD).
III. To measure outcomes of grade II-IV acute GVHD, non-relapse mortality, overall survival and chronic GVHD of EDR DLI.
IV. To assess the full donor chimerism rate in the CD3 compartment and immune reconstitution after EDR DLI.
OUTLINE:
Patients receive DLI intravenously (IV). Treatment repeats every 4-8 weeks for 5 doses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up periodically for 2 years.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60637-1470
- University of Chicago Comprehensive Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- INCLUSION CRITERIA PRIOR TO TRANSPLANT:
- The clinical trial will be offered to all high risk (defined 3 below) patients with hematologic malignancies who require stem cell transplants as part of their standard of care using matched related or unrelated donors
Patients with high risk myeloid or lymphoid malignancies at stem cell transplant following American Society for Blood and Marrow Transplantation (ASBMT) criteria, including but not limited to conditions listed; these criteria apply BEFORE cyto-reductive therapy given within 28 days of planned conditioning:
- Refractory acute myelogenous or lymphoid leukemia
- Relapsed acute myelogenous or lymphoid leukemia
- Myelodysplastic syndromes with 5% or more blasts
- Chronic myelogenous leukemia in chronic phase 3 or more, blast phase presently, or second accelerated phase
- Recurrent or refractory malignant lymphoma or Hodgkin's disease with less than a partial response at transplant
- High risk chronic lymphocytic leukemia defined as no response or stable disease to the most recent treatment regimen
- DONORS: Matched related or unrelated donor stem cell transplant (SCT) matched at human leukocyte antigen (HLA) A- B, C, and DRB1 by molecular methods; 7 of 8 matched donor acceptable for related donors
- T-cell depletion with anti-thymocyte globulin (ATG) (rabbit or horse) or at least 30 mg of alemtuzumab total in the conditioning regimen
- Immune suppression; planned post-transplant immune suppression should include tacrolimus or cyclosporin monotherapy (i.e., calcineurin inhibitor or CN) for alemtuzumab regimens and a second immune suppressant for ATG treated patients; other agents may be used if CN intolerance or toxicity occurs post-transplant
- Zubrod performance status (PS) 0-2 or equivalent Karnofsky PS
- Eligible for allogeneic transplant in the treating physicians' judgment and by institutional standards
- ELIGIBILITY TO RECEIVE DLI POST-TRANSPLANT:
- Donor lymphocytes available or able to be collected
- No evidence of disease by standard morphology; minimal residual disease or molecular evidence of disease will not exclude
- Absolute neutrophil count >= 500/μl
- Platelet count >= 20,000/μl without transfusion for 7 days
- Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamate pyruvate transaminase (SGPT) =< 5 x upper limit of normal (ULN)
- Bilirubin =< 3 x ULN
- No evidence of grade II or higher acute GVHD or chronic GVHD at initiation of first DLI
- No systemic corticosteroids or immunosuppressive drugs (topical acceptable); replacement steroids for adrenal insufficiency are not excluded
Exclusion Criteria:
- EXCLUSION CRITERIA PRIOR TO TRANSPLANT:
- Pregnant or lactating females
- Hepatitis B with positive viral load prior to transplant conditioning or hepatitis C virus
- Human immune deficiency virus
- Psychiatric illness that may make compliance to the clinical protocol unmanageable or may compromise the ability of the patient to give informed consent
- Creatinine >= 2.0 mg/dL
- SGOT and SGPT >= 5 x ULN; liver biopsy preferred for such patients
- Bilirubin >= 3 x ULN (unless Gilbert's syndrome)
- Diffusing capacity of the lung for carbon monoxide (DLCO) < 50% corrected for hemoglobin
- Left ventricular ejection fraction or shortening fraction < 40%
- Unlikely to be able to procure additional donor lymphocytes
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment (DLI)
Patients receive DLI IV.
Treatment repeats every 4-8 weeks for 5 doses in the absence of disease progression or unacceptable toxicity.
|
Correlative studies
Given IV
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percentage of Patients Who Are Able to Receive at Least One DLI Treatment
Time Frame: Up to 2 years
|
Up to 2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression Free Survival (PFS)
Time Frame: 2 years
|
Time to relapse or death as a result of any cause was evaluated at 2 years and the progression free survival rate was reported.
|
2 years
|
Overall Survival (OS)
Time Frame: At 2 years
|
Computed using the Kaplan-Meier product-limit estimate and expressed as probabilities with a 95% CI.
|
At 2 years
|
Rate of Acute GVHD (aGVHD) With Any Grade
Time Frame: At 1 year and 2 year
|
Estimated by cumulative incidence method.
|
At 1 year and 2 year
|
Rate of Chronic GVHD (cGVHD)
Time Frame: At 1 year and 2 year
|
Estimated by cumulative incidence method.
|
At 1 year and 2 year
|
Treatment-related Mortality
Time Frame: At 2 year
|
Estimated by cumulative incidence method.
Cumulative incidence of treatment-related mortality with relapse of the original disease as the competing risk will be calculated.
|
At 2 year
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Virus Diseases
- Infections
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphatic Diseases
- Immunoproliferative Disorders
- Neoplasms by Site
- Disease Attributes
- Disease
- Bone Marrow Diseases
- Hematologic Diseases
- Hemorrhagic Disorders
- Myeloproliferative Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- DNA Virus Infections
- Bacterial Infections and Mycoses
- Neoplastic Processes
- Tumor Virus Infections
- Neoplasms, Plasma Cell
- Precancerous Conditions
- Epstein-Barr Virus Infections
- Herpesviridae Infections
- Leukemia, B-Cell
- Cell Transformation, Neoplastic
- Carcinogenesis
- Eye Neoplasms
- Lymphadenopathy
- Lymphoma
- Lymphoma, Follicular
- Lymphoma, B-Cell
- Lymphoma, Large B-Cell, Diffuse
- Syndrome
- Myelodysplastic Syndromes
- Hematologic Neoplasms
- Leukemia
- Leukemia, Myeloid
- Leukemia, Myeloid, Acute
- Hodgkin Disease
- Recurrence
- Lymphoma, Non-Hodgkin
- Preleukemia
- Mycoses
- Burkitt Lymphoma
- Lymphoma, Mantle-Cell
- Lymphoma, B-Cell, Marginal Zone
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Lymphoma, Large-Cell, Immunoblastic
- Plasmablastic Lymphoma
- Waldenstrom Macroglobulinemia
- Leukemia, Lymphocytic, Chronic, B-Cell
- Leukemia, Lymphoid
- Lymphoma, T-Cell
- Lymphoma, T-Cell, Peripheral
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
- Leukemia, Myeloid, Chronic-Phase
- Blast Crisis
- Lymphoma, T-Cell, Cutaneous
- Leukemia, T-Cell
- Leukemia-Lymphoma, Adult T-Cell
- Mycosis Fungoides
- Sezary Syndrome
- Lymphoma, Large-Cell, Anaplastic
- Lymphomatoid Granulomatosis
- Leukemia, Myeloid, Accelerated Phase
- Lymphoma, Extranodal NK-T-Cell
- Intraocular Lymphoma
- Lymphoproliferative Disorders
- Immunoblastic Lymphadenopathy
- Leukemia, Hairy Cell
- Leukemia, Large Granular Lymphocytic
Other Study ID Numbers
- 12-1191
- NCI-2013-00782 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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