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CompletedNCT00425802Updated Oct 31, 2017Results posted

Chemotherapy, Total-Body Irradiation, Rituximab, and Donor Stem Cell Transplant in Treating Patients With B-Cell Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia

A Phase 2 interventional study of anti-thymocyte globulin and filgrastim in Leukemia and Lymphoma, sponsored by Memorial Sloan Kettering Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2017-10-31.

Sponsored by Memorial Sloan Kettering Cancer Center · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
61
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study summary

RATIONALE: Giving low doses of chemotherapy and total-body irradiation before a donor stem cell transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. Also, monoclonal antibodies, such as rituximab, can find cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving rituximab before transplant and cyclosporine and mycophenolate mofetil after transplant may stop this from happening.

PURPOSE: This phase II trial is studying the side effects and how well giving chemotherapy and radiation therapy together with rituximab and donor stem cell transplant works in treating patients with B-cell non-Hodgkin's lymphoma or chronic lymphocytic leukemia.

02

Conditions studied

  • Leukemia
  • Lymphoma

Keywords

  • noncontiguous stage II adult diffuse large cell lymphoma
  • recurrent adult diffuse large cell lymphoma
  • stage III adult diffuse large cell lymphoma
  • stage IV adult diffuse large cell lymphoma
  • B-cell chronic lymphocytic leukemia
  • refractory chronic lymphocytic leukemia
  • stage III chronic lymphocytic leukemia
  • stage IV chronic lymphocytic leukemia
  • noncontiguous stage II mantle cell lymphoma
  • recurrent mantle cell lymphoma
  • stage III mantle cell lymphoma
  • stage IV mantle cell lymphoma
  • noncontiguous stage II grade 1 follicular lymphoma
  • noncontiguous stage II grade 2 follicular lymphoma
  • recurrent grade 1 follicular lymphoma
  • recurrent grade 2 follicular lymphoma
  • stage III grade 1 follicular lymphoma
  • stage III grade 2 follicular lymphoma
  • stage IV grade 1 follicular lymphoma
  • stage IV grade 2 follicular lymphoma
  • noncontiguous stage II small lymphocytic lymphoma
  • recurrent small lymphocytic lymphoma
  • stage III small lymphocytic lymphoma
  • stage IV small lymphocytic lymphoma
  • noncontiguous stage II marginal zone lymphoma
  • recurrent marginal zone lymphoma
  • splenic marginal zone lymphoma
  • stage III marginal zone lymphoma
  • stage IV marginal zone lymphoma
  • noncontiguous stage II adult immunoblastic large cell lymphoma
  • stage III adult immunoblastic large cell lymphoma
  • stage IV adult immunoblastic large cell lymphoma
  • extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
  • nodal marginal zone B-cell lymphoma
  • recurrent adult immunoblastic large cell lymphoma
03

In context

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's enrollment of 61 is above the median of 40 across 4,508 interventional studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

Memorial Sloan Kettering Cancer Center is the lead sponsor of 1,930 studies on the registry; 328 are open to participants now.

Of its 129 completed or terminated interventional studies of FDA-regulated products, 66 (51%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of 1 of the following:

    • CD20-positive aggressive B-cell non-Hodgkin's lymphoma (NHL), including any of the following subtypes:

      • Diffuse large cell lymphoma*, meeting 1 of the following criteria:

        • Relapsed disease after initial therapy, but failed to mobilize or had bone marrow involvement and therefore is not suitable for an autologous stem cell transplantation
        • High-intermediate- or high-risk second-line, age-adjusted International Prognostic Index score and in second complete remission (CR) or partial remission (PR) after autologous stem cell transplantation
        • Failed prior autologous stem cell transplantation and in PR or better after salvage chemotherapy

      • Large cell transformation of indolent NHL or chronic lymphocytic leukemia (CLL), meeting the following criteria:

        • In CR or PR of the large cell component of disease after salvage chemotherapy or autologous stem cell transplantation

      • Mantle cell lymphoma*, meeting 1 of the following criteria:

        • High-risk disease (e.g., p53 positivity) and in first CR or PR after initial therapy
        • Relapsed disease after initial therapy and in second or third CR or PR after salvage chemotherapy NOTE: *No progressive disease at allograft work-up

    • CD20-positive indolent NHL (e.g., follicular lymphoma, small cell lymphoma, or marginal zone NHL) OR CLL

      • Second or subsequent progression (pre-allograft cytoreduction necessary, but CR or PR not required)
  • Relapsed disease must be biopsy-proven

  • Must have received pre-allograft salvage chemotherapy, including 1 of the following:

    • Single autologous stem cell transplantation using high-dose chemotherapy conditioning within the past 120 days
    • At least 2 courses of intensive combination chemotherapy (e.g., RICE [rituximab, ifosfamide, carboplatin, etoposide]), according to diagnosis, within the past 80 days
    • CLL patients who have received CAMPATH do not have to receive pre-allograft salvage chemotherapy

  • HLA-compatible related or unrelated donor available

    • HLA-matched ≥ 9/10 of the A, B, C, DRB1, and DQB1 loci, as tested by high resolution typing

      • One allele mismatch allowed

PATIENT CHARACTERISTICS:

  • Karnofsky performance status 70-100%
  • Creatinine \< 1.2 mg/mL OR creatinine clearance ≥ 50 mL/min
  • Bilirubin \< 2.5 mg/dL
  • AST and ALT ≤ 3 times upper limit of normal (unless benign congenital hyperbilirubinemia is present)
  • Spirometry and corrected DLCO ≥ 50% of normal
  • LVEF ≥ 40%
  • Albumin ≥ 2.5 g/dL
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No active uncontrolled infection, including active infection with Aspergillus or other mold
  • No HIV infection
  • No hepatitis B antibody or antigen positivity

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior allogeneic transplantation
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
61 participants (actual)

Study arms

  • Other
    treatment

    This is a phase 2 study of a treatment regimen consisting of a non-myeloablative (NMA) conditioning regimen incorporating low dose chemotherapy and low dose radiation as well as peri-transplant Rituximab and the transplantation of peripheral blood stem cells (PBSC) or bone marrow if PBSC collection not possible from an HLA compatible related or unrelated donor in patients with B cell lymphoid malignancies including diffuse large cell (DLC) and mantle cell non-Hodgkin's lymphoma (NHL), indolent B cell NHL, or chronic lymphocytic leukemia (CLL).

    Biological: anti-thymocyte globulin · Biological: filgrastim · Biological: graft-versus-tumor induction therapy · Biological: rituximab · Drug: cyclophosphamide · Drug: cyclosporine · Drug: fludarabine phosphate · Drug: mycophenolate mofetil · Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantation · Radiation: total-body irradiation

Interventions

  • Biologicalanti-thymocyte globulin
  • Biologicalfilgrastim
  • Biologicalgraft-versus-tumor induction therapy
  • Biologicalrituximab
  • Drugcyclophosphamide
  • Drugcyclosporine
  • Drugfludarabine phosphate
  • Drugmycophenolate mofetil
  • Procedurenonmyeloablative allogeneic hematopoietic stem cell transplantation
  • Radiationtotal-body irradiation
06

What researchers measure

Primary outcomes

  1. Overall Survival at 1 Year

    Time frame: 1 year

Secondary outcomes

  1. Time to Neutrophil Engraftment

    Time frame: 2 years

  2. Time to Platelet Engraftment

    Time frame: 1 year

  3. Incidence of Moderate to Severe Grades II to IV Graft Versus Host Disease (GVHD) at 100 Days

    Time frame: 100 days

  4. Incidence of Chronic GVHD at 1 Year

    Time frame: 1 year

  5. Immune Reconstruction/CD4+ Count at 3 Months

    Time frame: 3 months

  6. Response to Treatment

    Time frame: 2 years

  7. Immune Reconstruction/CD4+ Count at 6 Months

    Time frame: 6 months

  8. Immune Reconstruction/CD4+ Count at 1 Year

    Time frame: 1 year

07

Results

Posted Oct 31, 2017

Participant flow

Protocol Open to Accrual 11/28/2006 Protocol Closed to Accrual 4/22/2014 Primary Completion Date 10/28/2016 Recruitment Location is the medical clinic

Participant flow — Overall Study
MilestoneTreatment
Started61
Completed61
Not completed0

Outcome measures

PrimaryOverall Survival at 1 Year
Time frame:
1 year
Reported as:
Number · percentage of participants
Overall Survival at 1 Year
percentage of participantsTreatment
Overall Survival at 1 Year90 (81 to 98)
SecondaryTime to Neutrophil Engraftment
Time frame:
2 years
Reported as:
Median · days
Time to Neutrophil Engraftment
daysTreatment
Time to Neutrophil Engraftment15 (10 to 25)
SecondaryTime to Platelet Engraftment
Time frame:
1 year
Reported as:
Median · days
Time to Platelet Engraftment
daysTreatment
Time to Platelet Engraftment12 (6 to 40)
SecondaryIncidence of Moderate to Severe Grades II to IV Graft Versus Host Disease (GVHD) at 100 Days
Time frame:
100 days
Reported as:
Number · percentage of patients
Incidence of Moderate to Severe Grades II to IV Graft Versus Host Disease (GVHD) at 100 Days
percentage of patientsTreatment
Incidence of Moderate to Severe Grades II to IV Graft Versus Host Disease (GVHD) at 100 Days18 (7 to 29)
SecondaryIncidence of Chronic GVHD at 1 Year
Time frame:
1 year
Reported as:
Number · percentage of participants
Incidence of Chronic GVHD at 1 Year
percentage of participantsTreatment
Incidence of Chronic GVHD at 1 Year14 (3 to 24)
SecondaryImmune Reconstruction/CD4+ Count at 3 Months
Time frame:
3 months
Reported as:
Median · cells/microliters
Immune Reconstruction/CD4+ Count at 3 Months
cells/microlitersTreatment
Immune Reconstruction/CD4+ Count at 3 Months253 (160 to 343)
SecondaryResponse to Treatment
Time frame:
2 years
Reported as:
Count of participants · Participants
Response to Treatment
ParticipantsTreatment
Complete Response22
Partial Response17
Stable Disease11
Progression of Disease1
SecondaryImmune Reconstruction/CD4+ Count at 6 Months
Time frame:
6 months
Reported as:
Median · cells/microliter
Immune Reconstruction/CD4+ Count at 6 Months
cells/microliterTreatment
Immune Reconstruction/CD4+ Count at 6 Months312 (174 to 457)
SecondaryImmune Reconstruction/CD4+ Count at 1 Year
Time frame:
1 year
Reported as:
Median · cells/microliter
Immune Reconstruction/CD4+ Count at 1 Year
cells/microliterTreatment
Immune Reconstruction/CD4+ Count at 1 Year333 (18 to 1317)

Adverse events

Collected over 2 years. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Treatment9/61 (14.8%)26/61 (42.6%)59/61 (96.7%)
Most frequent serious events
Showing 10 of 36
Most frequent serious events
EventTreatment
DiarrheaGastrointestinal disorders9/61
Fever (in the absence of neutropenia)General disorders8/61
Infection, otherInfections and infestations7/61
Rash/desquamationSkin and subcutaneous tissue disorders4/61
Death not assoc w CTCAE term - Disease progressionGeneral disorders3/61
HypoxiaRespiratory, thoracic and mediastinal disorders3/61
Febrile NeutropeniaBlood and lymphatic system disorders2/61
Infection - catheter relatedInfections and infestations2/61
PneumoniaRespiratory, thoracic and mediastinal disorders2/61
HyperbilirubinemiaInvestigations1/61
Most frequent other events
Most frequent other events
EventTreatment
HyperglycemiaMetabolism and nutrition disorders26/61
CreatinineInvestigations25/61
Alanine AminotransferaseInvestigations13/61
Aspartate AminotransferaseInvestigations13/61
BilirubinInvestigations7/61
Alkaline phosphataseInvestigations6/61
HypermagnesemiaMetabolism and nutrition disorders5/61
Infection, otherInfections and infestations3/61

Baseline characteristics

Age, Continuous
Age, Continuous(years)Treatment
Median54 (33 to 69)
Sex: Female, Male
Sex: Female, Male(Participants)Treatment
Female11
Male50
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Treatment
Hispanic or Latino2
Not Hispanic or Latino59
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Treatment
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American1
White59
More than one race0
Unknown or Not Reported1
Region of Enrollment
Region of Enrollment(Participants)Treatment
United States61
08

Study locations

1 site
  • Memorial Sloan Kettering Cancer Center
    New York, New York 10065, United States
09

References and documents

Publications

  • Sauter CS, Lechner L, Scordo M, Zheng J, Devlin SM, Fleming SE, Castro-Malaspina H, Moskowitz CH. Pretransplantation fluorine-18-deoxyglucose--positron emission tomography scan lacks prognostic value in chemosensitive B cell non-hodgkin lymphoma patients undergoing nonmyeloablative allogeneic stem cell transplantation. Biol Blood Marrow Transplant. 2014 Jun;20(6):881-4. doi: 10.1016/j.bbmt.2014.02.009. Epub 2014 Feb 15. PubMed 24534109 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 31, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00425802
Lead sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Jan 23, 2007
Start date
Nov 28, 2006
Primary completion
Oct 28, 2016
Completion
Oct 28, 2016
Results posted
Oct 31, 2017
Last update
Oct 31, 2017

Study contacts

Hugo R. Castro-Malaspina, MD
principal investigator · Memorial Sloan Kettering Cancer Center
Juliet Barker, MBBS
principal investigator · Memorial Sloan Kettering Cancer Center
Craig Moskowitz, MD
principal investigator · Memorial Sloan Kettering Cancer Center
View the source record on ClinicalTrials.gov ↗

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