- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02220985
Selective Depletion of CD45RA+ T Cells From Allogeneic Peripheral Blood Stem Cell Grafts From HLA-Matched Related and Unrelated Donors in Preventing GVHD
A Phase II Study Evaluating Selective Depletion of CD45RA+ T Cells From Allogeneic Peripheral Blood Stem Cell Grafts From HLA-Matched Related and Unrelated Donors for Prevention of GVHD
Study Overview
Status
Conditions
- Lymphoblastic Lymphoma
- Childhood Acute Myeloid Leukemia in Remission
- Recurrent Acute Myeloid Leukemia
- Refractory Acute Myeloid Leukemia
- Myelodysplastic Syndrome With Excess Blasts
- Childhood Acute Lymphoblastic Leukemia in Remission
- Recurrent Childhood Acute Lymphoblastic Leukemia
- Recurrent Childhood Acute Myeloid Leukemia
- Blastic Plasmacytoid Dendritic Cell Neoplasm
- Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
- Recurrent Acute Lymphoblastic Leukemia
- Recurrent Chronic Myelogenous Leukemia, BCR-ABL1 Positive
- Refractory Acute Lymphoblastic Leukemia
- Myelodysplastic Syndrome With Excess Blasts-2
- Acute Leukemia of Ambiguous Lineage
- Acute Undifferentiated Leukemia
- Acute Biphenotypic Leukemia
- Allogeneic Hematopoietic Stem Cell Transplant Recipient
- Acute Myeloid Leukemia in Remission
- Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
- Acute Lymphoblastic Leukemia in Remission
- Donor
- Myelodysplastic Syndrome With Excess Blasts-1
Intervention / Treatment
- Other: Laboratory Biomarker Analysis
- Drug: Cyclophosphamide
- Procedure: Allogeneic Hematopoietic Stem Cell Transplantation
- Drug: Methotrexate
- Radiation: Total-Body Irradiation
- Drug: Fludarabine Phosphate
- Drug: Tacrolimus
- Drug: Thiotepa
- Drug: Mycophenolate Mofetil
- Procedure: Peripheral Blood Stem Cell Transplantation
- Procedure: Peripheral Blood Stem Cell Transplantation
Detailed Description
OUTLINE: Patients are assigned to 1 of 4 treatment arms.
CONDITIONING:
ARMS A AND C (high-intensity myeloablative conditioning): Patients undergo total body irradiation twice daily (BID) on days -10 to -7. Patients also receive thiotepa intravenously (IV) over 4 hours on days -6 and -5 and fludarabine phosphate IV over 30 minutes on days -6 to -2.
ARMS B AND D (lower-intensity myeloablative conditioning): Patients receive cyclophosphamide IV over 1 hour on day -6, fludarabine phosphate IV over 30 minutes on days -6 to -2, and thiotepa IV over 4 hours on days -5 and -4. Patients also undergo total body irradiation once daily (QD) on days -2 and -1.
TRANSPLANT: In all arms, patients undergo allogeneic HSCT with granulocyte colony-stimulating factor (GCSF)-mobilized CD34-enriched PBSC and CD45RA-depleted cells on day 0.
GVHD PROPHYLAXIS:
ARMS A AND C: Beginning day -1, patients receive tacrolimus IV over 22-24 hours or orally (PO) (BID if given PO) for 50 days with taper in the absence of GVHD. Patients also receive methotrexate IV on days 1, 3, 6, and 11.
ARMS B AND D: Beginning day -1, patients receive tacrolimus IV over 22-24 hours or PO (BID if given PO) for 50 days and mycophenolate mofetil IV and PO every 8 hours on days -3 to approximately day 30, with or without taper at the discretion of the treating physician. Mycophenolate mofetil should be continued or resumed after day 30 if donor chimerism is low, after discussion with the principal investigator.
After completion of study treatment, patients are followed up at 80-100 days, 360 days, and then yearly for up to 5 years.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, United States, 15232
- University of Pittsburgh Cancer Institute (UPCI)
-
-
Washington
-
Seattle, Washington, United States, 98109
- Fred Hutch/University of Washington Cancer Consortium
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Patients who are considered appropriate candidates for allogeneic hematopoietic stem cell transplantation and have one of the following diagnoses:
- Acute lymphocytic leukemia in first or subsequent remission
- Acute myeloid leukemia in first or subsequent remission
- Acute lymphocytic leukemia in relapse or primary refractory disease with a circulating blast count of no more than 10,000/mm^3 (Arms A or C only)
- Acute myeloid leukemia in relapse or primary refractory disease with a circulating blast count of no more than 10,000/mm^3 (Arms A or C only)
- Refractory anemia with excess blasts (RAEB-1 and RAEB-2) (if the patient has received previous induction chemotherapy within 60 days)
- Chronic myelogenous leukemia with a history of accelerated phase or blast crisis (if the patient has received at least one course of induction chemotherapy)
- Other acute leukemia or related neoplasm (including but not limited to 'biphenotypic', 'undifferentiated' or 'ambiguous lineage' acute leukemia, blastic plasmacytoid dendritic cell neoplasm or lymphoblastic lymphoma)
- Patients 0-49 years old will be enrolled in Arm A or C (high-intensity)
- Patients 50-60 years old will be enrolled in Arm B or D (lower intensity); patients eligible for Arms B or D also include those who have received previous allogeneic HCT, or who have co-morbid conditions rendering them unsuitable for high-dose conditioning, determined in consultation with the principal investigator
- Patient with a HLA-matched (HLA-A, B, C, and DR beta 1 [DRB1] molecularly matched) unrelated donor or related donor capable of donating PBSC
- DONOR INCLUSION:
- HLA-matched related donors >= 18 years and capable and willing to donate PBSC (Arms A and B)
- HLA-matched unrelated donors (HLA-A, B, C, and DRB1 matched based on high-resolution typing) capable and willing to donate PBSC (Arms C and D)
Exclusion Criteria:
- Patients with central nervous system (CNS) involvement refractory to intrathecal chemotherapy and/or standard cranial-spinal radiation
- Patients on other experimental protocols for prevention of acute GVHD
- Patient weight >= 100 kg; patients >= 70 kg with MUDs must be discussed with the principal investigator
- Patients who are human immunodeficiency virus positive (HIV+)
- Patients with uncontrolled infections for whom myeloablative HCT is considered contraindicated by the consulting infectious disease physician (upper respiratory tract viral infection does not constitute an uncontrolled infection in this context)
- Patients with organ dysfunction
- ARM A OR C EXCLUSION:
- Creatinine > 1.5 mg/dl at the present time; patients with a known history of creatinine > 1.5 mg/dl must have a current estimated creatinine clearance of > 40 ml/min
- Cardiac ejection fraction < 45%
- Diffusing capacity of the lung for carbon monoxide (DLCO) corrected < 60%; patients who are unable to perform pulmonary function tests (for example, due to young age and/or developmental status) will be excluded if the oxygen (O2) saturation is < 92% on room air
- Liver function abnormality; patients who have liver function tests (LFTs) (including total bilirubin, aspartate aminotransferase [AST] and alanine aminotransferase [ALT]) >= twice the upper limit of normal should be evaluated by a gastrointestinal (GI) physician; unless there is a clear precipitating factor (such as an azole, methotrexate, Bactrim or another drug); if the GI physician considers that HCT on the high-intensity arms of protocol is contraindicated for that patient the patient may be considered for treatment on the lower intensity arm of the protocol or excluded from the protocol; patients with Gilbert's syndrome and no other known liver function abnormality and patients with reversible drug-related transaminitis do not necessarily require GI consultation and may be included on the high-intensity arms of the protocol
- ARM B OR D EXCLUSION:
- Creatinine > 2.0 mg/dl at the present time; patients with a known history of creatinine > 1.5 mg/dl must have a current estimated creatinine clearance > 40 ml/min
- Cardiac ejection fraction < 35%
- DLCO corrected < 50%; patients who are unable to perform pulmonary function tests (for example, due to young age and/or developmental status) will be excluded if the O2 saturation is < 92% on room air; patients with a DLCO 50-60% must also have a partial pressure of oxygen (pO2) of > 80 mmHg
- Liver function abnormality; patients who have LFTs >= twice the upper limit of normal should be evaluated by a GI physician unless there is a clear precipitating factor (such as an azole, methotrexate, Bactrim or another drug); patients with fulminant liver failure, cirrhosis with evidence of portal hypertension or bridging fibrosis, alcoholic hepatitis, esophageal varices, a history of bleeding esophageal varices, hepatic encephalopathy, or correctable hepatic synthetic dysfunction evidenced by prolongation of the prothrombin time, ascites related to portal hypertension, bacterial or fungal abscess, biliary obstruction, chronic viral hepatitis with total serum bilirubin > 3 mg/dL, and symptomatic biliary disease will be excluded
- Patients will be excluded from Arms A and C if they have received a previous myeloablative transplant; patients who have received a prior HCT at least 6 months prior may be considered for inclusion on Arms B or D after discussion with the principal investigator (PI)
- Patients with a life expectancy < 3 months from co-existing disease other than the leukemia or RAEB
- Patients who are pregnant or breast-feeding
- Fertile patients of child bearing age unwilling to use contraception during and for 12 months post-transplant
- Patients with a significant other medical conditions that would make them unsuitable for transplant
- Patients with a known hypersensitivity to tacrolimus, methotrexate (Arm A or C) or MMF (Arm B or D)
- DONOR EXCLUSION:
- Donors who are HIV-1, HIV-2, human T-lymphotropic virus (HTLV)-1, HTLV-2 seropositive or with active hepatitis B or hepatitis C virus infection
- Donors who fail eligibility requirements for donation of cells or tissue for donation of a Human Cell and Tissue Products (HCT/P) will be excluded unless use of the cells complies urgent medical need or allogeneic use in a first-degree or second-degree relative
- Unrelated donors donating outside of the United States of America (USA)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm A (MRD)
HIGH-INTENSITY MYELOABLATIVE CONDITIONING: Patients undergo total body irradiation BID on days -10 to -7. Patients also receive thiotepa IV over 4 hours on days -6 and -5 and fludarabine phosphate IV over 30 minutes on days -6 to -2. TRANSPLANT: In all arms, patients undergo allogeneic HSCT with GCSF-mobilized CD34-enriched PBSC and CD45RA-depleted cells on day 0. GVHD PROPHYLAXIS: Beginning day -1, patients receive tacrolimus IV over 22-24 hours or PO (BID if given PO) for 50 days with taper in the absence of GVHD. Patients also receive methotrexate IV on days 1, 3, 6, and 11. |
Correlative studies
Given IV
Other Names:
Undergo allogeneic HSCT
Other Names:
Given IV
Other Names:
Undergo TBI
Other Names:
Given IV
Other Names:
Given IV or PO
Other Names:
Given IV
Other Names:
Undergo PBSCT with GCSF-mobilized CD34-enriched PBSC
Other Names:
Undergo PBSCT with CD45RA-depleted cells
Other Names:
|
Experimental: Arm B (MRD)
LOWER-INTENSITY MYELOABLATIVE CONDITIONING: Patients receive cyclophosphamide IV over 1 hour on day -6, fludarabine phosphate IV over 30 minutes on days -6 to -2, and thiotepa IV over 4 hours on days -5 and -4. Patients also undergo total body irradiation QD on days -2 and -1. TRANSPLANT: In all arms, patients undergo allogeneic HSCT with GCSF-mobilized CD34-enriched PBSC and CD45RA-depleted cells on day 0. GVHD PROPHYLAXIS: Beginning day -1, patients receive tacrolimus IV over 22-24 hours or PO (BID if given PO) for 50 days and mycophenolate mofetil IV and PO every 8 hours on day -3 to approximately day 30, with or without taper at the discretion of the treating physician. Mycophenolate mofetil should be continued or resumed after day 30 if donor chimerism is low, after discussion with the Principal Investigator. |
Correlative studies
Given IV
Other Names:
Undergo allogeneic HSCT
Other Names:
Undergo TBI
Other Names:
Given IV
Other Names:
Given IV or PO
Other Names:
Given IV
Other Names:
Given IV and PO
Other Names:
Undergo PBSCT with GCSF-mobilized CD34-enriched PBSC
Other Names:
Undergo PBSCT with CD45RA-depleted cells
Other Names:
|
Experimental: Arm C (MUD)
HIGH-INTENSITY MYELOABLATIVE CONDITIONING: Patients undergo total body irradiation BID on days -10 to -7. Patients also receive thiotepa IV over 4 hours on days -6 and -5 and fludarabine phosphate IV over 30 minutes on days -6 to -2. TRANSPLANT: In all arms, patients undergo allogeneic HSCT with G-CSF-mobilized CD34-enriched PBSC and CD45RA-depleted cells on day 0. GVHD PROPHYLAXIS: Beginning day -1, patients receive tacrolimus IV over 22-24 hours or PO (BID if given PO) for 50 days with taper in the absence of GVHD. Patients also receive methotrexate IV on days 1, 3, 6, and 11. |
Correlative studies
Given IV
Other Names:
Undergo allogeneic HSCT
Other Names:
Given IV
Other Names:
Undergo TBI
Other Names:
Given IV
Other Names:
Given IV or PO
Other Names:
Given IV
Other Names:
Undergo PBSCT with GCSF-mobilized CD34-enriched PBSC
Other Names:
Undergo PBSCT with CD45RA-depleted cells
Other Names:
|
Experimental: Arm D (MUD)
LOWER-INTENSITY MYELOABLATIVE CONDITIONING: Patients receive cyclophosphamide IV over 1 hour on day -6, fludarabine phosphate IV over 30 minutes on days -6 to -2, and thiotepa IV over 4 hours on days -5 and -4. Patients also undergo total body irradiation QD on days -2 and -1. TRANSPLANT: In all arms, patients undergo allogeneic HSCT with G-CSF-mobilized CD34-enriched PBSC and CD45RA-depleted cells on day 0. GVHD PROPHYLAXIS: Beginning day -1, patients receive tacrolimus IV over 22-24 hours or PO (BID if given PO) for 50 days and mycophenolate mofetil IV and PO every 8 hours on day -3 to approximately day 30, with or without taper at the discretion of the treating physician. Mycophenolate mofetil should be continued or resumed after day 30 if donor chimerism is low, after discussion with the Principal Investigator. |
Correlative studies
Given IV
Other Names:
Undergo allogeneic HSCT
Other Names:
Given IV
Other Names:
Given IV or PO
Other Names:
Given IV
Other Names:
Given IV and PO
Other Names:
Undergo PBSCT with GCSF-mobilized CD34-enriched PBSC
Other Names:
Undergo PBSCT with CD45RA-depleted cells
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Occurrence of chronic graft-versus-host disease (GHVD), defined operationally as the occurrence of compatible symptoms meeting National Institutes of Health criteria and requiring systemic pharmacological immunosuppression
Time Frame: Up to 5 years
|
Match related donor (MRD)-high intensity (Arm A), MRD-lower intensity (Arm B), match unrelated donor (MUD)-high intensity (Arm C) and MUD-lower intensity (Arm D) cohorts will be analyzed separately.
|
Up to 5 years
|
Use of additional immune suppressive agents other than first line therapy (prednisone and tacrolimus/cyclosporine)
Time Frame: Up to 5 years
|
Up to 5 years
|
|
Time to completion of prednisone
Time Frame: Up to 5 years
|
Up to 5 years
|
|
Time to completion of all immunosuppression
Time Frame: Up to 5 years
|
Up to 5 years
|
|
Requirement of immunosuppression after transplant
Time Frame: At 2 years after transplant
|
At 2 years after transplant
|
|
Presence of acute graft-versus-host disease (GVHD) grades II-IV
Time Frame: Up to day 100
|
Defined operationally as the occurrence of compatible symptoms or signs in the skin, gastrointestinal tract, or liver.
|
Up to day 100
|
Requirement for secondary systemic therapy for acute graft-versus-host disease (GVHD) management
Time Frame: Up to day 100
|
Up to day 100
|
|
Graft failure
Time Frame: Up to day 28
|
Defined operationally as failure to reach an absolute neutrophil count (ANC) of > 500/ul for 3 consecutive days by day 28 or irreversible decrease in ANC to < 100 after an established donor graft.
|
Up to day 28
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to platelet count > 20,000/uL for 3 days without transfusion
Time Frame: Up to 5 years
|
Up to 5 years
|
|
Time to platelet count > 50,000/uL for 3 days without transfusion
Time Frame: Up to 5 years
|
Up to 5 years
|
|
Time to absolute neutrophil count (ANC) of > 500/uL on the first of three consecutive days
Time Frame: Up to 5 years
|
Up to 5 years
|
|
Time to absolute neutrophil count (ANC) of > 1,000/uL on the first of three consecutive test results
Time Frame: Up to 5 years
|
Up to 5 years
|
|
Chimerism analysis
Time Frame: Up to 360 days
|
Will be analyzed from peripheral blood or marrow.
|
Up to 360 days
|
Relapse
Time Frame: Up to 5 years
|
Defined by the presence of malignant cells in marrow, peripheral blood, or extramedullary sites by histopathology.
|
Up to 5 years
|
Transplant related mortality
Time Frame: Up to 5 years
|
Defined as mortality in any patient for whom there has not been a diagnosis of relapse.
|
Up to 5 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Marie Bleakley, Fred Hutch/University of Washington Cancer Consortium
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
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
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Disease Attributes
- Disease
- Bone Marrow Diseases
- Hematologic Diseases
- Myeloproliferative Disorders
- Anemia
- Neoplastic Processes
- Precancerous Conditions
- Cell Transformation, Neoplastic
- Carcinogenesis
- Anemia, Refractory
- Chronic Disease
- Syndrome
- Myelodysplastic Syndromes
- Leukemia
- Leukemia, Myeloid
- Leukemia, Myeloid, Acute
- Recurrence
- Preleukemia
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Leukemia, Lymphoid
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
- Blast Crisis
- Leukemia, Myeloid, Accelerated Phase
- Anemia, Refractory, with Excess of Blasts
- Leukemia, Biphenotypic, Acute
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Antirheumatic Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Dermatologic Agents
- Anti-Bacterial Agents
- Antibiotics, Antineoplastic
- Reproductive Control Agents
- Antitubercular Agents
- Abortifacient Agents, Nonsteroidal
- Abortifacient Agents
- Folic Acid Antagonists
- Antibiotics, Antitubercular
- Calcineurin Inhibitors
- Cyclophosphamide
- Fludarabine
- Fludarabine phosphate
- Methotrexate
- Tacrolimus
- Mycophenolic Acid
- Thiotepa
Other Study ID Numbers
- 2684.00 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium)
- R01HL121568 (U.S. NIH Grant/Contract)
- 2P01CA018029 (U.S. NIH Grant/Contract)
- NCI-2014-01301 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- RG9214012 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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