NCT00912223

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2009

Longer than P75 for phase_2

Geographic Reach
1 country

21 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 1, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 3, 2009

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
4 months until next milestone

Results Posted

Study results publicly available

November 21, 2016

Completed
Last Updated

December 9, 2022

Status Verified

December 1, 2022

Enrollment Period

5.6 years

First QC Date

June 1, 2009

Results QC Date

August 5, 2016

Last Update Submit

December 7, 2022

Conditions

Lymphoma, Non-Hodgkin

Keywords

Follicular Non-Hodgkin's LymphomaHematopoietic Stem Cell Transplant (HSCT)Non-Myeloablative Transplant (NST)

Outcome Measures

Primary Outcomes (1)

  • Progression-Free Survival (PFS)

    Patients are considered a failure for this endpoint if they die, or if they relapse/progress or receive anti-lymphoma therapy not including planned post-transplant radiation.

    Year 2

Secondary Outcomes (12)

  • Graft Failure

    Day 30

  • Donor Cell Engraftment

    Days 30 and 100

  • Time to Neutrophil Recovery

    Day 60

  • Acute Graft-versus-Host Disease (GVHD)

    Day 100

  • Chronic GVHD

    Year 2

  • +7 more secondary outcomes

Study Arms (1)

Hematopoietic Stem Cell Transplant

EXPERIMENTAL

Participants will undergo a non-myeloablative allogeneic hematopoietic stem cell transplant.

Biological: Hematopoietic Stem Cell Transplant

Interventions

Hematopoietic Stem Cell TransplantBIOLOGICAL

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.

Hematopoietic Stem Cell Transplant

Eligibility Criteria

Age1 Year - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Must have confirmed CD20+ follicle center lymphoma that meets one of the following:
  • Histologically confirmed recurrent Revised European American Lymphoma (REAL) Classification CD20+ follicle center lymphoma, follicular grades I and II
  • Histologically confirmed World Health Organization (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:
  • Patients in second or subsequent complete remission (CR)
  • Patients in first or subsequent partial remission (PR)
  • 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).
  • 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 human leukocyte antigen (HLA)-matched donors that meet the following criteria:
  • /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,
  • /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:
  • Heart: Left ventricular ejection fraction at rest greater than 45%
  • +3 more criteria

You may not qualify if:

  • 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 polymerase chain reaction (PCR)+, or hepatitis C ab or PCR+

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (21)

City of Hope National Medical Center

Duarte, California, 91010-3000, United States

Location

University of California, San Diego (UCSD) Medical Center

La Jolla, California, 92093, United States

Location

University of California, Davis Medical Center

Sacramento, California, 95817, United States

Location

Stanford Hospital and Clinics

Stanford, California, 94305, United States

Location

University of Florida College of Medicine

Gainesville, Florida, 32610-0277, United States

Location

H. Lee Moffitt Cancer Center

Tampa, Florida, 33624, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Dana-Farber Cancer Institute (DFCI)/Brigham & Women's Hospital

Boston, Massachusetts, 02114, United States

Location

Dana-Farber Cancer Institute (DFCI)/Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198-7680, United States

Location

University of North Carolina Hospital at Chapel Hill

Chapel Hill, North Carolina, 27599-7305, United States

Location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

University Hospitals of Cleveland/Case Western

Cleveland, Ohio, 44106-5061, United States

Location

Ohio State/Arthur G. James Cancer Hospital

Columbus, Ohio, 43210, United States

Location

University of Oklahoma Medical Center

Oklahoma City, Oklahoma, 73104, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232-8210, United States

Location

University of Texas, MD Anderson Cancer Research Center

Houston, Texas, 77030, United States

Location

West Virginia University

Morgantown, West Virginia, 26506-9162, United States

Location

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53792-5156, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53211, United States

Location

Related Publications (1)

  • Laport GG, Wu J, Logan B, Bachanova V, Hosing C, Fenske T, Longo W, Devine SM, Nademanee A, Gersten I, Horowitz M, Lazarus HM, Riches ML; Blood and Marrow Transplant Clinical Trials Network. Reduced-Intensity Conditioning with Fludarabine, Cyclophosphamide, and High-Dose Rituximab for Allogeneic Hematopoietic Cell Transplantation for Follicular Lymphoma: A Phase Two Multicenter Trial from the Blood and Marrow Transplant Clinical Trials Network. Biol Blood Marrow Transplant. 2016 Aug;22(8):1440-1448. doi: 10.1016/j.bbmt.2016.04.014. Epub 2016 Apr 23.

    PMID: 27118571RESULT

MeSH Terms

Conditions

Lymphoma, Non-HodgkinLymphoma, Follicular

Interventions

Stem Cell Transplantation

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Cell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Results Point of Contact

Title
Adam Mendizabal, PhD
Organization
The Emmes Corporation
amendizabal@emmes.com
301-251-1161

Study Officials

  • Mary Horowitz, MD, MS

    Center for International Blood and Marrow Transplant Research (CIBMTR), Medical College of Wisconsin

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2009

First Posted

June 3, 2009

Study Start

April 1, 2009

Primary Completion

November 1, 2014

Study Completion

August 1, 2016

Last Updated

December 9, 2022

Results First Posted

November 21, 2016

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will share

Findings will be published in a manuscript.

Time Frame
Within 6 months of official study closure at participating sites.
Access Criteria
Available to the public.
More information

Locations

US(21)