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Recurrent Grade 1 Follicular LymphomaPhase 2/3NCT00096460

Autologous or Donor Stem Cell Transplantation in Treating Patients With Recurrent Non-Hodgkin's Lymphoma (BMT CTN 0202)

A Phase 2/3 study testing Cyclophosphamide and Rituximab, Filgrastim and Chemotherapy or Radiation therapy in people with Recurrent Grade 1 Follicular Lymphoma and Recurrent Grade 2 Follicular Lymphoma, run by Medical College of Wisconsin at 30 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This study is designed as a Phase II/III, multi-center trial, comparing two transplant strategies to determine whether non-myeloablative allogeneic Hematopoietic Stem Cell Transplantation (HSCT) will improve long-term progression-free survival compared to autologous HSCT. Read more about this study

Who is it for?
Ages Up to 75 years
What is being tested?
Cyclophosphamide and Rituximab, Filgrastim and Chemotherapy or Radiation therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
30 sitesUnited States
Study dates
Aug 2004to Mar 2009
Phase
Phase 2/3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 75 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • Karnofsky performance score less than 70%
  • Follicular lymphoma that show histologic evidence of transformation
  • Uncontrolled hypertension
  • Patients with uncontrolled bacterial, viral or fungal infection (currently taking medication and progression without clinical improvement).
  • Prior malignancies except resected basal cell carcinoma or treated cervical carcinoma in situ; cancer treated with curative intent more than 5 years previously will be reviewed on a case-by-case basis by a Protocol Chair or Medical Monitor.
  • Pregnant (positive Beta Human chorionic gonadotropin (β-HCG)) or breastfeeding
Show all 10Show fewer
  • Seropositive for Human immunodeficiency virus (HIV)
  • Unwilling to use contraceptive techniques during treatment
  • Prior autologous or allogeneic HSCT
  • Known anaphylactic reaction to rituximab

Trial locations and contacts

30 sites in 1 country.

30 sites in 1 country

United States30 sites

  • University of Michigan Medical Center

    Ann Arbor, Michigan, 48105-2967

  • Emory University

    Atlanta, Georgia, 30322

  • BMT Group of Georgia

    Atlanta, Georgia, 30342

  • Loyola University

    Atlanta, Georgia, 60153

  • Indiana BMT at Beech Grove

    Beech Grove, Indiana, 46107

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02115

  • University Hospitals of Cleveland/Case Western

    Cleveland, Ohio, 44106-5061

  • Baylor University Medical Center

    Dallas, Texas, 75246

  • Karmanos Cancer Institute/BMT

    Detroit, Michigan, 48201

  • City of Hope National Medical Center

    Duarte, California, 91010-3000

  • Duke University Medical Center

    Durham, North Carolina, 27705

  • University of Florida College of Medicine (Shands)

    Gainesville, Florida, 32610-0277

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • University of Texas/MD Anderson CRC

    Houston, Texas, 77030

  • Kansas City Cancer Centers

    Kansas City, Missouri, 64111

  • Scripps Clinic

    La Jolla, California, 92037

  • UCSD Medical Center

    La Jolla, California, 92093

  • University of Wisconsin Hospital and Clinics

    Madison, Wisconsin, 53792-5156

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53211

  • University of Minnesota

    Minneapolis, Minnesota, 55455

  • Vanderbilt University

    Nashville, Tennessee, 37232-8210

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198-7680

  • University of Pennsylvania Cancer Center

    Philadelphia, Pennsylvania, 19104

  • University of Pittsburgh Cancer Institute

    Pittsburgh, Pennsylvania, 15232

  • Providence Portland Medical Center

    Portland, Oregon, 97213

  • Oregon Health Sciences University

    Portland, Oregon, 97239-3098

  • Virginia Commonwealth University MCV Hospitals

    Richmond, Virginia, 23298

  • Washington University/Barnes Jewish Hospital

    St Louis, Missouri, 63110

  • Stanford Hospital and Clinics

    Stanford, California, 94305

  • H. Lee Moffitt Cancer Center

    Tampa, Florida, 33624

Other trials in United States

About this study

Official title: Autologous Versus Non-Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) for Patients With Chemosensitive Follicular Non-Hodgkin's Lymphoma Beyond First Complete Response or First Partial Response (BMT CTN #0202)

This study is designed as a Phase II/III, multi-center trial, comparing two transplant strategies to determine whether non-myeloablative allogeneic Hematopoietic Stem Cell Transplantation (HSCT) will improve long-term progression-free survival compared to autologous HSCT. Recipients will be biologically assigned to the appropriate treatment arm depending on the availability of a Human Leukocyte Antigen (HLA) matched sibling.

Read the detailed description

BACKGROUND:

Although patients with follicular non-Hodgkin's lymphoma (NHL) typically experience a relatively indolent course, the disease is rarely curable with conventional chemotherapy. Patients with follicular NHL are usually treated only when symptoms require palliation or if bulky disease exists since no survival advantage has been shown as compared to administering conventional treatment at initial diagnosis. While most patients achieve a remission with initial chemotherapy, a continuous pattern of relapse occurs, resulting in progressively shorter remission durations. Additionally, the increased response rates conferred by anthracycline-containing regimens have not translated into improved survival and thus the median survival time of 6 to 10 years has not been significantly impacted over the last decade.

DESIGN NARRATIVE:

The overall study design is a comparison of two treatment arms determined by biologic assignment, based on the availability of an HLA-matched sibling, in patients diagnosed with relapsed follicular non-Hodgkin's lymphoma. Patients without an HLA-matched sibling will receive an autologous HSCT. Patients with an HLA-matched sibling will receive a non-myeloablative allogeneic HSCT.

The overall study design is that of biologic assignment, based on the availability of an HLA-matched sibling, to one of two strategies to improve the outcome for follicular lymphoma patients with chemosensitive disease. All patients will undergo cytoreduction with cyclophosphamide 4 gm/m^2 and rituximab 375 mg/m^2 x 2 doses. Rituximab will be given in two doses, approximately 1 week apart, with the cyclophosphamide administered the day after the first dose of rituximab. Patients assigned to the autologous arm will have their hematopoietic stem cells mobilized from this cytoreductive regimen. Patients with an HLA-matched sibling will undergo a non-myeloablative allogeneic HSCT. Pre-transplant conditioning will consist of fludarabine 30 mg/m^2/day and cyclophosphamide 750 mg/m^2/day x 3 days with rituximab 375 mg/m^2/day on Days -13 and -6 pre-HSCT and on Days +1 and +8 post-HSCT. The immunosuppressive regimen will consist of tacrolimus and methotrexate (MTX) to control graft-versus-host and host-versus-graft reactions. Patients without an HLA-matched sibling who have collected an adequate autologous hematopoietic cell graft, defined as at least 2.0 * 10^6 CD34+ cells/kg, will receive a preparative regimen of total body irradiation (TBI) 1200 cGy or Carmustine (BCNU) 15 mg/kg. In addition, VP-16 60 mg/kg and cyclophosphamide 100 mg/kg will be given for both autologous preparative regimens. Post-autologous HSCT therapy with rituximab 375 mg/m^2 weekly x 4 doses will commence between Days 42-75 post-HSCT.

Being tested
Cyclophosphamide and Rituximab, Filgrastim, Chemotherapy or Radiation therapy, Non-myeloablative Conditioning regimen, Allogeneic transplant
Medical subject headings
Lymphoma, Follicular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cyclophosphamide and RituximabDrug

    Also called Cytoxan® and Rituxan

    Prior to undergoing HSCT, all patients will receive Cyclophosphamide 4 gm/m2 with Rituximab 375 mg/m2 x 2 doses and G-CSF support.

  • FilgrastimDrug

    Also called G-CSF

    Autologous HSCT patients will receive 10 mcg/kg/day and allogeneic HSCT patients will receive 5 mcg/kg/day subcutaneous (SQ) or intravenous (IV) starting 2 days after the initiation of Cyclophosphamide.

  • Chemotherapy or Radiation therapyRadiation

    Also called Etoposide and Carmustine, BCNU and VP-16

    Chemotherapy - BCNU 15 mg/kg IV x 1 dose to be administered over 2 hours on Day -6 pre-HSCT. VP-16 60 mg/kg IV x 1 dose to be administered over 4 hours on Day -4.

    Radiation - administered at a rate of < 20 cGy/min in one of the following doses; 120 cGy/fraction are administered at no less than 4-hour intervals three times/day or 2 times/day for a total of 10 doses (1200 cGy) over 4 days (Day -8, -7, -6 and -5), or doses of 150 cGy/fraction twice daily for a total of 8 doses (1200 cGy) over 4 days (Day -8, -7, -6 and -5). VP-16 60 mg/kg IV x 1 dose to be administered over 4 hours on Day -4 pre-HSCT.

    Cyclophosphamide 100 mg/kg IV x 1 dose to be administered over 2 hours on Day -2 pre-HSCT. G-CSF 5 mcg/kg SQ or IV to start on Day +5 post-HSCT and continue until ANC > 500/mm3 x 3 days.

  • Non-myeloablative Conditioning regimenDrug

    Also called Fludarabine, Cyclophosphamide, and Rituximab, Fludara, Cytoxan®, and Rituxan

    Fludarabine 30 mg/m2 IV x 3 doses total to be administered daily over 30 minutes on Days -6, -5 and -4 pre-HSCT. Cyclophosphamide 750 mg/m IV x 3 doses total to be administered daily over 1 hour on Days -6, -5 and -4 pre-HSCT. Administer cyclophosphamide approximately 4 hours after start of fludarabine infusion. Rituximab 375 mg/m2 IV x 4 doses total to be administered on Days -13 and -6 pre HSCT and Days +1 and +8 post HSCT.

  • Allogeneic transplantProcedure or surgery

    Also called HSCT

    Infusion of G-CSF mobilized allogeneic hematopoietic stem cells

  • Autologous transplantProcedure or surgery

    Also called HSCT

    Infusion of G-CSF mobilized autologous hematopoietic stem cells

  • Rituximab maintenance therapyDrug

    Also called Rituxan

    Patients must have sufficiently recovered from autologous HSCT in order to receive rituximab maintenance therapy as specified below:

    Dose #1: Day +42 post-autologous HSCT Dose #2: Day +49 post-autologous HSCT Dose #3: Day +56 post-autologous HSCT Dose #4: Day +63 post-autologous HSCT

  • GVHD ProphylaxisDrug

    Also called Tacrolimus and Methotrexate, Prograf® and MTX

    Tacrolimus 0.09 mg/kg/day PO, based on body weight formulas will start on Day -2 and continue until Day +90 post-HSCT. Tacrolimus (or cyclosporine, if applicable) will be given orally in a twice-daily divided dose. Methotrexate 5 mg/m2 Intravenous Pyelogram (IVP) will be administered on Days +1, +3 and +6 post-HSCT.

Study groups in NCT00096460
Study groupRoleWhat they receive
Autologous TransplantActive comparatorCyclophosphamide and Rituximab with Filgrastim conditioning and chemotherapy or radiation therapy prior to autologous Hematopoietic Stem Cell Transplant (HSCT). Rituximab maintenance therapy following HSCT.
Receives: Drug: Cyclophosphamide and Rituximab; Drug: Filgrastim; Radiation: Chemotherapy or Radiation therapy; Procedure: Autologous transplant; Drug: Rituximab maintenance therapy
Allogeneic TransplantActive comparatorNon-myeloablative conditioning regimen followed by allogeneic Hematopoietic Stem Cell Transplant (HSCT). Graft-versus-Host Disease (GVHD) Prophylaxis therapy following HSCT.
Receives: Drug: Cyclophosphamide and Rituximab; Drug: Filgrastim; Drug: Non-myeloablative Conditioning regimen; Procedure: Allogeneic transplant; Drug: GVHD Prophylaxis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Lymphoma Progression-free Survival

    Measured: Three years post-Hematopoietic Stem Cell Transplant (HSCT)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Nov 2004 (estimated)
  2. Study startAug 2004
  3. Primary completionMar 2006
  4. Study completionMar 2009

Why it stopped: lower than anticipated accrual

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00096460
Sponsor's protocol ID
BMTCTN0202
Other IDs
U01HL069294, BMT CTN 0202, 5U24CA076518
Status last verified
Dec 2022
First submitted
9 Nov 2004
Last updated
5 Jan 2023
Data monitoring committee
Yes
Individual data sharing
Yes

Publications

  • Tomblyn MR, Ewell M, Bredeson C, Kahl BS, Goodman SA, Horowitz MM, Vose JM, Negrin RS, Laport GG. Autologous versus reduced-intensity allogeneic hematopoietic cell transplantation for patients with chemosensitive follicular non-Hodgkin lymphoma beyond first complete response or first partial response. Biol Blood Marrow Transplant. 2011 Jul;17(7):1051-7. doi: 10.1016/j.bbmt.2010.11.004. Epub 2010 Nov 10.

    PubMed 21073974

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Cyclophosphamide and Rituximab, Filgrastim and Chemotherapy or Radiation therapy in people with Recurrent Grade 1 Follicular Lymphoma and Recurrent Grade 2 Follicular Lymphoma, run by Medical College of Wisconsin at 30 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 5 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Sep 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Lymphoma Progression-free Survival (time frame: Three years post-Hematopoietic Stem Cell Transplant (HSCT)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00096460, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2023.

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