Trial record 14 of 803 for:    "Mantle cell lymphoma"

Tacrolimus and ATG as GVHD Prophylaxis in Patients Undergoing Related Donor HSCT

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier:
NCT01414127
First received: August 9, 2011
Last updated: April 8, 2013
Last verified: April 2013
  Purpose

This phase II trial studies how well giving tacrolimus and anti-thymocyte globulin together works in preventing graft-vs-host disease (GVHD) in patients with hematologic malignancies undergoing donor peripheral blood stem cell transplant (PBSCT). Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving tacrolimus together with anti-thymocyte globulin may stop this from happening


Condition Intervention Phase
Accelerated Phase Chronic Myelogenous Leukemia
Adult Acute Lymphoblastic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission
Adult Acute Myeloid Leukemia in Remission
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)
Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
Adult Grade III Lymphomatoid Granulomatosis
Adult Nasal Type Extranodal NK/T-cell Lymphoma
Anaplastic Large Cell Lymphoma
Angioimmunoblastic T-cell Lymphoma
Chronic Myelomonocytic Leukemia
Chronic Phase Chronic Myelogenous Leukemia
Contiguous Stage II Adult Burkitt Lymphoma
Contiguous Stage II Adult Diffuse Large Cell Lymphoma
Contiguous Stage II Adult Diffuse Mixed Cell Lymphoma
Stage II Adult Diffuse Small Cleaved Cell Lymphoma
Stage II Adult Immunoblastic Large Cell Lymphoma
Contiguous Stage II Adult Lymphoblastic Lymphoma
Contiguous Stage II Grade 1 Follicular Lymphoma
Contiguous Stage II Grade 2 Follicular Lymphoma
Contiguous Stage II Grade 3 Follicular Lymphoma
Contiguous Stage II Mantle Cell Lymphoma
Cutaneous B-cell Non-Hodgkin Lymphoma
de Novo Myelodysplastic Syndromes
Hepatosplenic T-cell Lymphoma
Intraocular Lymphoma
Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable
Nodal Marginal Zone B-cell Lymphoma
Noncontiguous Stage II Adult Burkitt Lymphoma
Noncontiguous Stage II Adult Diffuse Large Cell Lymphoma
Noncontiguous Stage II Adult Diffuse Mixed Cell Lymphoma
Noncontiguous Stage II Adult Lymphoblastic Lymphoma
Noncontiguous Stage II Grade 1 Follicular Lymphoma
Noncontiguous Stage II Grade 2 Follicular Lymphoma
Noncontiguous Stage II Grade 3 Follicular Lymphoma
Noncontiguous Stage II Mantle Cell Lymphoma
Peripheral T-cell Lymphoma
Post-transplant Lymphoproliferative Disorder
Previously Treated Myelodysplastic Syndromes
Primary Myelofibrosis
Recurrent Adult Acute Lymphoblastic Leukemia
Recurrent Adult Acute Myeloid Leukemia
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 Grade III Lymphomatoid Granulomatosis
Recurrent Adult Hodgkin Lymphoma
Recurrent Adult Immunoblastic Large Cell Lymphoma
Recurrent Adult Lymphoblastic Lymphoma
Recurrent Adult T-cell Leukemia/Lymphoma
Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma
Recurrent Grade 1 Follicular Lymphoma
Recurrent Grade 2 Follicular Lymphoma
Recurrent Grade 3 Follicular Lymphoma
Recurrent Mantle Cell Lymphoma
Recurrent Marginal Zone Lymphoma
Recurrent Mycosis Fungoides/Sezary Syndrome
Recurrent Small Lymphocytic Lymphoma
Refractory Chronic Lymphocytic Leukemia
Refractory Hairy Cell Leukemia
Small Intestine Lymphoma
Splenic Marginal Zone Lymphoma
Stage I Adult Burkitt Lymphoma
Stage I Adult Diffuse Large Cell Lymphoma
Stage I Adult Diffuse Mixed Cell Lymphoma
Stage I Adult Diffuse Small Cleaved Cell Lymphoma
Stage I Adult Hodgkin Lymphoma
Stage I Adult Immunoblastic Large Cell Lymphoma
Stage I Adult Lymphoblastic Lymphoma
Stage I Adult T-cell Leukemia/Lymphoma
Stage I Chronic Lymphocytic Leukemia
Stage I Cutaneous T-cell Non-Hodgkin Lymphoma
Stage I Grade 1 Follicular Lymphoma
Stage I Grade 2 Follicular Lymphoma
Stage I Grade 3 Follicular Lymphoma
Stage I Mantle Cell Lymphoma
Stage I Marginal Zone Lymphoma
Stage I Multiple Myeloma
Stage I Mycosis Fungoides/Sezary Syndrome
Stage I Small Lymphocytic Lymphoma
Stage II Adult Hodgkin Lymphoma
Stage II Adult T-cell Leukemia/Lymphoma
Stage II Chronic Lymphocytic Leukemia
Stage II Cutaneous T-cell Non-Hodgkin Lymphoma
Stage II Multiple Myeloma
Stage II Mycosis Fungoides/Sezary Syndrome
Stage III Adult Burkitt Lymphoma
Stage III Adult Diffuse Large Cell Lymphoma
Stage III Adult Diffuse Mixed Cell Lymphoma
Stage III Adult Diffuse Small Cleaved Cell Lymphoma
Stage III Adult Hodgkin Lymphoma
Stage III Adult Immunoblastic Large Cell Lymphoma
Stage III Adult Lymphoblastic Lymphoma
Stage III Adult T-cell Leukemia/Lymphoma
Stage III Chronic Lymphocytic Leukemia
Stage III Cutaneous T-cell Non-Hodgkin Lymphoma
Stage III Grade 1 Follicular Lymphoma
Stage III Grade 2 Follicular Lymphoma
Stage III Grade 3 Follicular Lymphoma
Stage III Mantle Cell Lymphoma
Stage III Marginal Zone Lymphoma
Stage III Multiple Myeloma
Stage III Mycosis Fungoides/Sezary Syndrome
Stage III Small Lymphocytic Lymphoma
Stage IV Adult Burkitt Lymphoma
Stage IV Adult Diffuse Large Cell Lymphoma
Stage IV Adult Diffuse Mixed Cell Lymphoma
Stage IV Adult Diffuse Small Cleaved Cell Lymphoma
Stage IV Adult Hodgkin Lymphoma
Stage IV Adult Immunoblastic Large Cell Lymphoma
Stage IV Adult Lymphoblastic Lymphoma
Stage IV Adult T-cell Leukemia/Lymphoma
Stage IV Chronic Lymphocytic Leukemia
Stage IV Cutaneous T-cell Non-Hodgkin Lymphoma
Stage IV Grade 1 Follicular Lymphoma
Stage IV Grade 2 Follicular Lymphoma
Stage IV Grade 3 Follicular Lymphoma
Stage IV Mantle Cell Lymphoma
Stage IV Marginal Zone Lymphoma
Stage IV Mycosis Fungoides/Sezary Syndrome
Stage IV Small Lymphocytic Lymphoma
T-cell Large Granular Lymphocyte Leukemia
Testicular Lymphoma
Waldenstrom Macroglobulinemia
Drug: tacrolimus
Biological: anti-thymocyte globulin
Other: laboratory biomarker analysis
Other: flow cytometry
Procedure: allogeneic hematopoietic stem cell transplantation
Procedure: peripheral blood stem cell transplantation
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Phase II Study of Tacrolimus and Thymoglobulin, as Graft-versus-Host-Disease Prophylaxis in Patients Undergoing Related Donor Hematopoietic Cell Transplantation

Resource links provided by NLM:

Genetic and Rare Diseases Information Center resources: Lymphoma, Small Cleaved-cell, Diffuse Multiple Myeloma Chronic Myeloproliferative Disorders Acute Lymphoblastic Leukemia Leukemia, Myeloid Chronic Myeloid Leukemia Myelodysplastic Syndromes Hodgkin Lymphoma Waldenstrom Macroglobulinemia Acute Myelocytic Leukemia Acute Non Lymphoblastic Leukemia Homologous Wasting Disease Myelodysplastic/myeloproliferative Disease Acute Myeloid Leukemia, Adult Follicular Lymphoma B-cell Lymphomas Myelofibrosis Burkitt Lymphoma Lymphoma, Large-cell Lymphomatoid Granulomatosis Lymphoma, Large-cell, Immunoblastic Lymphoblastic Lymphoma Anaplastic Large Cell Lymphoma Chronic Lymphocytic Leukemia Leukemia, B-cell, Chronic Chronic Myelomonocytic Leukemia Mantle Cell Lymphoma Cutaneous T-cell Lymphoma Peripheral T-cell Lymphoma Leukemia, T-cell, Chronic Angioimmunoblastic T-cell Lymphoma Angioimmunoblastic Lymphadenopathy With Dysproteinemia Hairy Cell Leukemia Mycosis Fungoides Sezary Syndrome Large Granular Lymphocyte Leukemia
U.S. FDA Resources

Further study details as provided by Barbara Ann Karmanos Cancer Institute:

Primary Outcome Measures:
  • Proportion of aGVHD graded according to the Glucksberg criteria [ Time Frame: During the first 6 months post-transplant ] [ Designated as safety issue: No ]
    aGVHD is defined as any GVHD occurring within the first 100 days after transplant

  • Safety of tacrolimus and anti-thymocyte globulin [ Time Frame: Within the first 6 months post-transplant ] [ Designated as safety issue: Yes ]
    Defined by serious adverse events (SAE) related to this immunosuppressive regimen. Except for stopping rule for safety concern, no statistical analysis will be performed for this endpoint.


Secondary Outcome Measures:
  • Proportion of chronic GVHD [ Time Frame: Within 2 years after transplant ] [ Designated as safety issue: No ]
  • Time to engraftment: time to neutrophil (> 500) and platelet (> 25K) count recovery [ Time Frame: At days 10-12 post-transplant ] [ Designated as safety issue: No ]
  • Overall and disease-free survival [ Time Frame: At 2 years post PBSCT ] [ Designated as safety issue: No ]
  • Incidence of opportunistic infections, including fungal, and viral (CMV and EBV reactivation including PTLD) [ Time Frame: At weekly intervals beginning around day 21 and until day 100 post-transplant ] [ Designated as safety issue: No ]
  • Biomarkers and immunocorrelative studies [ Time Frame: At baseline, 30, 60, 90, and 180 days post transplant ] [ Designated as safety issue: No ]

Estimated Enrollment: 22
Study Start Date: November 2010
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Supportive care (GVHD prophylaxis)

GVHD PROPHYLAXIS: Patients receive tacrolimus IV continuously or PO on days -3 to 60 with taper to day 100 (high-risk disease) or on days -3 to 100 with taper to day 180 (low-risk disease). Patients also receive anti-thymocyte globulin IV over 4-6 hours on days -3 to -1.

PREPARATIVE REGIMEN: Patients receive standard of care (at the Karmanos Cancer Institute) preparative regimens as chosen by the treating physician, based on diagnosis.

TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.

Drug: tacrolimus
Given IV or PO
Other Names:
  • FK 506
  • Prograf
Biological: anti-thymocyte globulin
Given IV
Other Names:
  • ATG
  • ATGAM
  • lymphocyte immune globulin
  • Thymoglobulin
Other: laboratory biomarker analysis
Correlative studies
Other: flow cytometry
Correlative studies
Procedure: allogeneic hematopoietic stem cell transplantation
Undergo allogeneic PBSCT
Procedure: peripheral blood stem cell transplantation
Undergo allogeneic PBSCT
Other Names:
  • PBPC transplantation
  • PBSC transplantation
  • peripheral blood progenitor cell transplantation
  • transplantation, peripheral blood stem cell

Detailed Description:

PRIMARY OBJECTIVES:

I. To determine the incidence and severity of acute GVHD (aGVHD) following human leukocyte antigen (HLA) matched related donor hematopoietic peripheral blood transplant in patients with hematologic malignancies that receive the immunosuppressive combination of Tacrolimus and Thymoglobulin (anti-thymocyte globulin) as GVHD prophylaxis.

II. To determine the safety of this combination in the first six months post transplant.

SECONDARY OBJECTIVES:

I. To determine engraftment time of neutrophils (absolute neutrophil count > 0.5 x 10^9/L for 3 consecutive days), and platelets (platelet count > 20 X 10^9/L for 3 consecutive days).

II. To determine incidence of opportunistic infections, defined as infection that occurs in people with weakened immune systems and caused by an organism that does not normally cause disease. These include: fungal infections, pneumocytics carinii pneumonia (PCP), and viral infections (cytomegalovirus [CMV], varicella zoster virus [VZV], herpes simplex virus [HSV], BK virus [BK], Epstein-Barr virus [EBV], including post-transplant lymphoproliferative disorder [PTLD]).

III. To estimate incidence of chronic GVHD (cGVHD) at two years. IV. To determine overall and disease free survival at two years. V. To assess immune response with immunocorrelative studies both pre and at various points post transplant.

OUTLINE:

GVHD PROPHYLAXIS: Patients receive tacrolimus intravenously (IV) continuously or orally (PO) on days -3 to 60 with taper to day 100 (high-risk disease) or on days -3 to 100 with taper to day 180 (low-risk disease). Patients also receive anti-thymocyte globulin IV over 4-6 hours on days -3 to -1.

PREPARATIVE REGIMEN: Patients receive standard of care (at the Karmanos Cancer Institute) preparative regimens chosen by the treating physician, based on diagnosis.

TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.

After completion of study treatment, patients are followed up for 2 years.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Suitable related donor as determined by the treating physician
  • High resolution molecular HLA typing is mandatory for HLA Class I and II
  • Diagnosis of hematological malignancy
  • Patients with one of the following hematologic malignancies, and felt to be transplant candidates by their treating physician are eligible to enroll on this protocol:
  • Non-Hodgkin lymphoma, any complete remission (CR)/partial remission (PR)
  • Hodgkin disease, any CR/PR/stable disease (SD)
  • Acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL) any CR; for non-CR AML or ALL, bone marrow blast < 20% within 4 weeks of transplant and peripheral blood (PB) absolute blast count < 500/μl on the day of initiation of conditioning
  • Myelodysplastic syndrome (MDS), treated or untreated
  • Chronic myelogenous leukemia (CML) in chronic phase or accelerated phase
  • Chronic myelomonocytic leukemia (CMML)
  • Multiple myeloma, any CR/PR/SD
  • Chronic lymphocytic leukemia (CLL) any CR/PR
  • Myelofibrosis and other myeloproliferative disorders; bone marrow blasts less than 20 percent within four weeks of transplant and peripheral blood absolute blast counts less than 500 per microliter on the day of initiation of conditioning
  • Age >= 18 and able to cooperate with oral medication intake
  • Filgrastim (G-CSF) mobilized Peripheral blood stem cells
  • Agrees to participate, and informed consent signed
  • Karnofsky performance status (KPS) >= 60, Eastern Cooperative Oncology Group (ECOG) performance status =< 2
  • Creatinine clearance > 60 mL/min
  • Ejection fraction > 50%
  • Serum bilirubin, alanine aminotransferase (ALT), aspartate aminotransferase (AST) less than 3 X upper limit of normal
  • Forced vital capacity (FVC), forced expiratory volume in one second (FEV1) or diffusion capacity of carbon monoxide (DLCO) > 50% predicted

Exclusion Criteria:

  • Bone marrow or Ex vivo engineered or processed graft (cluster of differentiation [CD]34+ enrichment, T-cell depletion, etc)
  • Patients with documented uncontrolled central nervous system (CNS) disease
  • Active donor or recipient serology positive for human immunodeficiency virus (HIV)
  • Known contraindication to administration of Tacrolimus or Thymoglobulin
  • Active Hepatitis B or C
  • Patients with coronary heart disease (recent myocardial infarctions, angina, cardiac stent, or bypass surgery in the last 6 months) need to be cleared with a stress echocardiogram or nuclear myocardial perfusion stress test, and cardiology consult; all other cardiac history will be at the discretion of the Principal Investigator
  • Oxygen usage at the time of enrollment
  • Patients with clinical ascites
  • Women who are pregnant or nursing
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01414127

Locations
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Sponsors and Collaborators
Barbara Ann Karmanos Cancer Institute
Investigators
Principal Investigator: Zaid Al-Kadhimi Barbara Ann Karmanos Cancer Institute
  More Information

No publications provided

Responsible Party: Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier: NCT01414127     History of Changes
Other Study ID Numbers: 2009-095, NCI-2011-00356
Study First Received: August 9, 2011
Last Updated: April 8, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Lymphoma, Mantle-Cell
Congenital Abnormalities
Primary Myelofibrosis
Burkitt Lymphoma
Neoplasms
Hodgkin Disease
Immunoblastic Lymphadenopathy
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Hairy Cell
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Leukemia, Myeloid, Accelerated Phase
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid, Chronic-Phase
Leukemia, Myelomonocytic, Chronic
Leukemia, T-Cell
Leukemia-Lymphoma, Adult T-Cell
Lymphoma
Lymphoma, Follicular
Lymphoma, Non-Hodgkin
Lymphomatoid Granulomatosis
Lymphoproliferative Disorders
Waldenstrom Macroglobulinemia
Multiple Myeloma
Neoplasms, Plasma Cell
Mycoses
Mycosis Fungoides

ClinicalTrials.gov processed this record on April 17, 2014