Trial record 1 of 1 for:    BMT CTN 0701 - A Phase II Trial of Non-Myeloablative Allogeneic Hematopoietic Cell Transplantation
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Effectiveness of a Blood Stem Cell Transplant That Uses Low Dose Chemotherapy in People With Relapsed Follicular Non-Hodgkin's Lymphoma (BMT CTN #0701)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Blood and Marrow Transplant Clinical Trials Network
Information provided by (Responsible Party):
Medical College of Wisconsin
ClinicalTrials.gov Identifier:
NCT00912223
First received: June 1, 2009
Last updated: April 2, 2013
Last verified: April 2013
  Purpose

Blood stem cell transplants are one treatment option for people with lymphoma or other types of blood cancers. For this type of treatment, family members or unrelated donors with a similar tissue type usually donate their blood stem cells to the transplant patients. This study will evaluate the effectiveness of a type of blood stem cell transplant that uses lower doses of chemotherapy in people with relapsed follicular non-Hodgkin's lymphoma (NHL).


Condition Intervention Phase
Lymphoma, Non-Hodgkin
Biological: Hematopoietic Stem Cell Transplant
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of Non-Myeloablative Allogeneic Hematopoietic Cell Transplantation for Patients With Relapsed Follicular Non-Hodgkin's Lymphoma Beyond First Complete Response (BMT CTN #0701)

Resource links provided by NLM:


Further study details as provided by Medical College of Wisconsin:

Primary Outcome Measures:
  • Progression-free survival at 2 years from the time of transplant [ Time Frame: Measured at Year 2 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Primary graft failure [ Time Frame: Measured at Day 30 ] [ Designated as safety issue: Yes ]
  • Secondary graft failure [ Time Frame: Measured at Day 100 ] [ Designated as safety issue: Yes ]
  • Donor cell engraftment [ Time Frame: Measured at Days 28, 56, 100, 180, and 365 ] [ Designated as safety issue: No ]
  • Acute graft-versus-host disease [ Time Frame: Measured at Day 100 ] [ Designated as safety issue: No ]
  • Chronic graft-versus-host disease [ Time Frame: Measured at Days 100, 180, 365, and 730 ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: Measured at Year 2 ] [ Designated as safety issue: No ]
  • Treatment-related mortality (TRM) [ Time Frame: Measured at Year 2 ] [ Designated as safety issue: Yes ]
  • Infections [ Time Frame: Measured at Year 2 ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: Measured at Year 2 ] [ Designated as safety issue: No ]
  • Immunologic reconstitution [ Time Frame: Measured at Days 100, 180, and 365 ] [ Designated as safety issue: No ]
  • Toxicities [ Time Frame: Measured at Days 28, 56, 100, 180, 365, and 730 ] [ Designated as safety issue: Yes ]
  • Serum rituximab levels [ Time Frame: Measured at Days 28, 100, 180, and 365 ] [ Designated as safety issue: No ]

Estimated Enrollment: 65
Study Start Date: April 2009
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hematopoietic Stem Cell Transplant
Participants will undergo a non-myeloablative allogeneic hematopoietic stem cell transplant.
Biological: Hematopoietic Stem Cell Transplant

NOTE: The - sign is the number of days before the transplant and the + sign is the number of days after the transplant.

The conditioning regimen will consist of the following:

  • Rituxan 375 mg/m^2 on Day -13
  • Rituxan 1000 mg/m^2 on Days -6, +1, and +8
  • Fludarabine 30 mg/m^2 on Days -5 to -3
  • Cyclophosphamide 750 mg/m^2 on Days -5, -4, -3

Day 0 will be the day of the transplant.

The GVHD prophylaxis will consist of the following:

  • Tacrolimus .09 mg/kg/po (Day -2 thru Day +180). Doses will be adjusted to maintain blood levels of 5-15 ng/mL.
  • Methotrexate 5 mg/m^2 (Days +1, +3, and +6). Unrelated donor recipients will receive a fourth dose on Day +11.

Detailed Description:

Follicular NHL, a type of blood cancer, is the second most common type of non-Hodgkin's lymphoma, with approximately 15,000 new cases being diagnosed each year in the United States. Chemotherapy is a common treatment option for people with NHL, and at first most people achieve cancer remission with initial chemotherapy. However, after the initial chemotherapy, people with this disease typically experience a continuous pattern of relapse that results in progressively shorter remission durations. A blood stem cell transplant is another treatment option for people with follicular NHL. In a blood stem cell transplant procedure, healthy blood stem cells are taken from a donor and transplanted into the patient. The cells can be donated by a family member or an unrelated donor who has a similar tissue type. Typically, people who are undergoing a blood stem cell transplant receive high doses of chemotherapy before the transplant to prepare their bodies to accept the donor stem cells. In this study, participants will undergo a type of stem cell transplant called a nonmyeloablative transplant, which involves a reduced intensity method of transplantation that does not require high doses of chemotherapy. The purpose of the study is to examine the effectiveness of a nonmyeloablative allogeneic blood stem cell transplant at improving survival rates in people with relapsed follicular NHL.

This study will enroll people with relapsed follicular NHL. At a baseline study visit, participants will undergo a medical history review, physical examination, blood collection, lung function testing, computed tomography (CT) scans, a bone marrow biopsy, and questionnaires to assess quality of life. Participants will be admitted to the hospital and on various days in the 2 weeks before the transplant, they will receive fludarabine, cyclophosphamide, rituximab, which are cancer medications, and tacrolimus, a medication that will help prevent graft-versus-host disease (GVHD), which is an attack by the donor cells on the body's normal tissues. Participants will then undergo the blood stem cell transplant. At various times during the 2 weeks after the transplant, participants will receive rituximab and methotrexate, which is another medication to prevent GVHD. They will also receive tacrolimus for at least 6 months to help prevent GVHD. Participants will remain in the hospital for as long as necessary to recover from the transplant. Follow-up study visits will occur weekly for Weeks 1 to 14, and then at Months 6, 12, 18, and 24. At each study visit, select baseline procedures will be repeated.

  Eligibility

Ages Eligible for Study:   1 Year to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must have confirmed CD20+ follicle center lymphoma that meets one of the following:

    1. Histologically confirmed recurrent Revised European American Lymphoma (REAL) Classification CD20+ follicle center lymphoma, follicular grades I and II
    2. Histologically confirmed WHO classification CD20+ follicular lymphoma grades 1, 2, or 3a.

      For either classification, the diffuse component of large cleaved cells (if present) cannot be greater than 50% of cellularity. Patients do not have to express t(14;18) to be eligible.

  • Any number of prior regimens (including autologous hematopoietic cell transplantation [HCT]); the most recent prior regimen must have occurred more than 28 days before study entry
  • Must demonstrate chemosensitive or radiosensitive disease to most recent prior regimen and meet one of the following criteria:

    1. Patients in second or subsequent complete remission (CR)
    2. Patients in first or subsequent partial remission (PR)
    3. Patients experiencing a relapse that demonstrates a response, as defined as largest nodal mass less than or equal to 3 cm or greater than or equal to 50% reduction in estimated lymph node volume measured as a product of bi-dimensional measurements (see protocol for detailed definition).
    4. Patients with stable follicular lymphoma are eligible if all lymph node masses are less than or equal to 3 cm and are smaller or unchanged in size to the most recent salvage regimen.
  • Patients with HLA-matched donors that meet the following criteria:

    1. 6/6 HLA-matched related donor. HLA typing must be performed by DNA methods for HLA-A and B at intermediate (or higher) resolution, and DRB1 at high resolution. The donor must be willing to donate peripheral blood stem cells and meet institutional criteria for stem cell donation. The donor must be medically eligible to donate stem cells according to individual transplant center criteria; or,
    2. 8/8 HLA-matched unrelated donor. HLA typing must be performed by DNA methods for HLA-A, B, C, and DRB1 at high resolution. The donor must be willing to donate peripheral blood stem cells and meet National Marrow Donor Program (NMDP) criteria for stem cell donation. The donor must be medically eligible to donate stem cells according to NMDP criteria.
  • Patients with adequate organ function, as measured by the following:

    1. Heart: Left ventricular ejection fraction at rest greater than 45%
    2. Lungs: Diffusing capacity of the lung for carbon monoxide (DLCO), forced expiratory volume in one second (FEV1), or forced vital capacity (FVC) greater than 50% of predicted (corrected for hemoglobin). For patients in whom pulse oximetry is performed, baseline O2 saturation greater than 85% (when lung function testing cannot be performed due to age restrictions)
    3. Liver: Bilirubin less than two times the upper limit of normal for age as per local laboratory; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than three times the upper limit of normal as per local laboratory
    4. Kidney: Calculated or measured creatinine clearance greater than or equal to 40 mL/min; if creatinine is greater than or equal to 1.5 mg/dL then 24-hour urine for measured creatinine clearance should be performed.

Exclusion Criteria:

  • Patients in first CR
  • Karnofsky performance score less than 70%
  • Patients with follicular lymphoma that demonstrates evidence of histologic transformation. In the presence of B symptoms, rapid growth of a single dominant site, or prolonged (> 2 yrs) interval since last tissue diagnosis, investigators are encouraged to consider re-biopsy of nodes prior to enrollment.
  • Uncontrolled hypertension
  • Uncontrolled bacterial, viral, or fungal infection (i.e., currently taking medication and progression of clinical symptoms)
  • Prior cancer, other than resected basal cell carcinoma or treated cervical carcinoma in situ. Cancer treated with curative intent less than 5 years will not be allowed unless approved by the medical monitor or protocol chair. Cancer treated with curative intent greater than 5 years will be allowed.
  • Pregnant or breastfeeding
  • Seropositive for human immunodeficiency virus (HIV)
  • Fertile men or women unwilling to use contraception from the time of initiation of conditioning until 6 months post-transplant
  • Prior allogeneic HSCT
  • Known anaphylactic reaction to rituximab
  • Seropositive for any of the following: HIV ab, hepatitis B sAg or PCR+, or hepatitis C ab or PCR+
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00912223

Locations
United States, California
City of Hope National Medical Center
Duarte, California, United States, 91010-3000
University of California, San Diego (UCSD) Medical Center
La Jolla, California, United States, 92093
University of California, Davis Medical Center
Sacramento, California, United States, 95817
Stanford Hospital and Clinics
Stanford, California, United States, 94305
United States, Florida
University of Florida College of Medicine
Gainesville, Florida, United States, 32610-0277
H. Lee Moffitt Cancer Center
Tampa, Florida, United States, 33624
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
United States, Massachusetts
Dana-Farber Cancer Institute (DFCI)/Brigham & Women's Hospital
Boston, Massachusetts, United States, 02114
Dana-Farber Cancer Institute (DFCI)/Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-7680
United States, North Carolina
University of North Carolina Hospital at Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7305
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
University Hospitals of Cleveland/Case Western
Cleveland, Ohio, United States, 44106-5061
Ohio State/Arthur G. James Cancer Hospital
Columbus, Ohio, United States, 43210
United States, Oklahoma
University of Oklahoma Medical Center
Oklahoma City, Oklahoma, United States, 73104
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232-8210
United States, Texas
University of Texas, MD Anderson Cancer Research Center
Houston, Texas, United States, 77030
United States, West Virginia
West Virginia University
Morgantown, West Virginia, United States, 26506-9162
United States, Wisconsin
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792-5156
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53211
Sponsors and Collaborators
Medical College of Wisconsin
Blood and Marrow Transplant Clinical Trials Network
Investigators
Study Director: Mary Horowitz, MD, MS Center for International Blood and Marrow Transplant Research (CIBMTR), Medical College of Wisconsin
  More Information

Additional Information:
No publications provided

Responsible Party: Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT00912223     History of Changes
Obsolete Identifiers: NCT00867074
Other Study ID Numbers: 657, U01HL069294
Study First Received: June 1, 2009
Last Updated: April 2, 2013
Health Authority: United States: Federal Government

Keywords provided by Medical College of Wisconsin:
Follicular Non-Hodgkin's Lymphoma
Hematopoietic Stem Cell Transplant (HSCT)
Non-Myeloablative Transplant (NST)

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Follicular
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on April 17, 2014