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CompletedNCT00039195Updated Aug 10, 2016Results posted

Chemotherapy and Rituximab With or Without Total-Body Irradiation and Peripheral Stem Cell Transplant in Treating Patients With Lymphoma

A Phase 2 interventional study of filgrastim and rituximab in Lymphoma, sponsored by Memorial Sloan Kettering Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2016-08-10.

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

Phase
Phase 2
Study type
Interventional
Enrollment
98
Allocation
Not applicable
Ages
18 Years to 64 Years
Sex
All
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Study summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining chemotherapy with monoclonal antibody therapy, total-body irradiation, and peripheral stem cell transplant may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving chemotherapy with rituximab followed by combination chemotherapy with or without rituximab, total-body irradiation, and peripheral stem cell transplant works in treating patients with lymphoma.

Read the detailed description

OUTLINE: Patients are stratified according to risk (low-intermediate vs high-intermediate or high).

Patients receive induction chemotherapy comprising cyclophosphamide IV, doxorubicin IV over 15 minutes, and vincristine IV over 1-2 minutes on day 1; oral prednisone once daily on days 1-5; and filgrastim (G-CSF) subcutaneously (SC) once daily on days 7-11 or PEG-filgrastim once at least 24 hours after infusion. Patients also receive rituximab IV 2-3 days apart for a total of 2 doses during the week prior to the first course of chemotherapy and on day 1 of courses 2-4 of chemotherapy. Treatment repeats every 14 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity.

After the completion of induction chemotherapy, patients undergo CT scan and positron emission tomography (PET) scanning. If the PET scan is positive in one or more nodal sites, a repeat biopsy is performed. Patients with a negative PET scan OR a negative repeat biopsy (including no evidence of lymphoma on repeat bone marrow biopsy) are assigned to receive regimen A for consolidation therapy. Patients with a positive repeat biopsy are assigned to receive regimen B for consolidation therapy.

  • Regimen A: Patients receive consolidation chemotherapy comprising etoposide IV over 1 hour on days 1-3, ifosfamide IV continuously over 24 hours on day 2, carboplatin IV on day 2, and G-CSF SC once daily on days 5-12 or PEG-filgrastim once at least 24 hours after infusion. Treatment repeats every 14 days for a total of 3 courses in the absence of disease progression or unacceptable toxicity.
  • Regimen B: Patients receive consolidation chemotherapy as in regimen A for 3 courses. Patients also receive rituximab IV on days -3 to -1 of course 3 of chemotherapy. Patients undergo leukapheresis at the completion of course 3 (G-CSF continues from day 5 until the end of leukapheresis). After completion of leukapheresis, patients begin a regimen of high-dose chemoradiotherapy comprising either total body irradiation twice daily on days -10 to -7 and ifosfamide IV over 1 hour and etoposide IV continuously on days -6 to -2 or BEAM chemotherapy comprising carmustine, etoposide, cytarabine, and melphalan. Autologous peripheral blood stem cells (APBSC) are reinfused on day 0. Patients also receive G-CSF SC daily beginning on day 5 and continuing until blood counts recover. Beginning on day 42 post-APBSC, if blood counts have recovered, patients receive rituximab IV once weekly for 4 weeks. Rituximab is repeated beginning on day 180 in the absence of disease progression.

Patients who receive consolidation therapy on regimen A are followed at 4-6 weeks after chemotherapy and patients who receive consolidation therapy on regimen B are followed at 90-120 days after transplantation. All patients are followed closely for 5 years and then annually thereafter.

PROJECTED ACCRUAL: A total of 40-98 patients will be accrued for this study within 4 years.

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Conditions studied

  • Lymphoma

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Keywords

  • stage I adult diffuse large cell lymphoma
  • stage III adult diffuse large cell lymphoma
  • stage IV adult diffuse large cell lymphoma
  • contiguous stage II adult diffuse large cell lymphoma
  • noncontiguous stage II adult diffuse 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 98 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 64 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed aggressive diffuse large B-cell lymphoma
  • CD20-positive disease
  • Age-adjusted International Prognostic Index II or III defined by the presence of at least 1 of the following:

    • Karnofsky performance status 10-70%
    • Lactate dehydrogenase greater than 200 U/L
    • Stage III or IV disease
  • Positron emission tomography avid measurable disease
  • No CNS involvement

PATIENT CHARACTERISTICS:

Age:

  • 18 to 64

Performance status:

  • See Disease Characteristics

Life expectancy:

  • Not specified

Hematopoietic:

  • Absolute neutrophil count greater than 1,000/mm\^3
  • Platelet count greater than 50,000/mm\^3

Hepatic:

  • Bilirubin less than 2.0 mg/dL unless history of Gilbert's disease or pattern consistent with Gilbert's disease
  • Hepatitis B surface antigen and hepatitis C antibody negative
  • No chronic, active, or persistent hepatitis

Renal:

  • Creatinine no greater than 1.5 mg/dL OR
  • Creatinine clearance greater than 60 mL/min
  • No chronic renal insufficiency

Cardiovascular:

  • Ejection fraction at least 50% by echocardiogram or MUGA scan
  • No myocardial infarction within the past 6 months
  • No unstable angina
  • No cardiac arrhythmias except chronic atrial fibrillation

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective barrier contraception
  • HIV negative
  • No other medical illness that would preclude study
  • No uncontrolled infection
  • No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior biologic therapy for malignancy

Chemotherapy:

  • No prior chemotherapy for malignancy

Endocrine therapy:

  • Prior steroids allowed if received no more than 1 week of therapy

Radiotherapy:

  • No prior radiotherapy for malignancy

Surgery:

  • No prior surgery for malignancy

Other:

  • No other prior therapy for malignancy
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Study design

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

Study arms

  • Experimental
    Induction R-CHOPac Therapy for patients with B-Cell Lymphoma

    Patients received 4 cycles if accelerated R-CHOP (cyclophosphamide. doxorubicin, vincristine and prednisone + rituximab) followed by 3 cycles ICE (ifosfamide, carboplatin and etoposide) consolidation therapy.

    Biological: filgrastim · Biological: rituximab · Drug: carboplatin · Drug: cyclophosphamide · Drug: doxorubicin hydrochloride · Drug: etoposide · Drug: ifosfamide · Drug: prednisone · Drug: vincristine sulfate · Procedure: peripheral blood stem cell transplantation · Radiation: radiation therapy

Interventions

  • Biologicalfilgrastim
  • Biologicalrituximab
  • Drugcarboplatin
  • Drugcyclophosphamide
  • Drugdoxorubicin hydrochloride
  • Drugetoposide
  • Drugifosfamide
  • Drugprednisone
  • Drugvincristine sulfate
  • Procedureperipheral blood stem cell transplantation
  • Radiationradiation therapy
06

What researchers measure

Primary outcomes

  1. Progression Free Survival

    Kaplan-Meier estimates will be used to verify the progression free survival.

    Time frame: 2 years

07

Results

Posted Aug 10, 2016

Participant flow

Participant flow — Overall Study
MilestoneInduction R-CHOPac Therapy
Started98
Completed98
Not completed0

Outcome measures

PrimaryProgression Free Survival

Kaplan-Meier estimates will be used to verify the progression free survival.

Time frame:
2 years
Reported as:
Number · percentage of patients progression free
Progression Free Survival
percentage of patients progression freeInduction R-CHOPac Therapy
Progression Free Survival79 (69 to 89)

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Induction R-CHOPac Therapy—20/98 (20.4%)98/98 (100%)
Most frequent serious events
Showing 10 of 24
Most frequent serious events
EventInduction R-CHOPac Therapy
Febrile neutropeniaGeneral disorders8/98
ThrombosisRespiratory, thoracic and mediastinal disorders4/98
Infection without neutropeniaInfections and infestations3/98
GI, otherGastrointestinal disorders2/98
HypotensionCardiac disorders2/98
NeutrophilsBlood and lymphatic system disorders2/98
PlateletsBlood and lymphatic system disorders2/98
Abdominal pain/crampingGastrointestinal disorders1/98
ArachnoiditisMusculoskeletal and connective tissue disorders1/98
Constitutional symptoms, otherGeneral disorders1/98
Most frequent other events
Showing 10 of 22
Most frequent other events
EventInduction R-CHOPac Therapy
LymphopeniaBlood and lymphatic system disorders94/98
Hemoglobin (Hgb)Blood and lymphatic system disorders89/98
HyperglycemiaMetabolism and nutrition disorders79/98
PlateletsBlood and lymphatic system disorders70/98
LeukocytesBlood and lymphatic system disorders68/98
NeutrophilsBlood and lymphatic system disorders64/98
HypocalcemiaMetabolism and nutrition disorders41/98
HypophosphatemiaMetabolism and nutrition disorders33/98
SGPT (ALT)Blood and lymphatic system disorders30/98
SGOT (AST)Blood and lymphatic system disorders22/98

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Induction R-CHOPac Therapy
<=18 years0
Between 18 and 65 years97
>=65 years1
Sex: Female, Male
Sex: Female, Male(Participants)Induction R-CHOPac Therapy
Female42
Male56
Region of Enrollment
Region of Enrollment(participants)Induction R-CHOPac Therapy
United States98
08

Study locations

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

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 10, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00039195
Lead sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI), Bristol-Myers Squibb, Genentech, Inc.
Responsible party
Sponsor
First posted
Jan 27, 2003
Start date
Nov 2006
Primary completion
Jan 2010
Completion
Jan 2010
Results posted
Aug 10, 2016
Last update
Aug 10, 2016

Study contacts

Craig Moskowitz, MD
study chair · Memorial Sloan Kettering Cancer Center
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.

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