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A Phase II Study Of Intensive Induction Chemotherapy Followed By Autologous Stem Cell Transplantation Plus Immunotherapy For Mantle Cell Lymphoma


Phase 2
18 Years
69 Years
Not Enrolling
Both
Lymphoma

Thank you

Trial Information

A Phase II Study Of Intensive Induction Chemotherapy Followed By Autologous Stem Cell Transplantation Plus Immunotherapy For Mantle Cell Lymphoma


OBJECTIVES:

- Determine the two-year progression-free survival of patients with mantle cell lymphoma
treated with intensive chemotherapy and rituximab with autologous peripheral blood stem
cell (PBSC) transplantation.

- Determine the complete and partial response rates of patients treated with this
regimen.

- Determine the disease-free and overall survival of patients treated with this regimen.

- Determine the autologous immune reconstitution in patients treated with this regimen.

- Determine the feasibility of this regimen in this patient population.

- Determine whether treatment with rituximab during autologous PBSC transplantation
reduces the amount of contaminating lymphoma in the autologous PBSC product.

OUTLINE: This is a multicenter study.

Patients receive induction therapy comprising rituximab IV over 4-6 hours on day 1;
methotrexate IV over 4 hours on day 2; cyclophosphamide IV over 2 hours, doxorubicin IV, and
vincristine IV on day 3; and oral prednisone on days 3-7. Patients also receive leucovorin
calcium IV every 6 hours beginning on day 3 and continuing until blood levels of
methotrexate are safe. Filgrastim (G-CSF) is administered subcutaneously (SC) beginning on
day 4 and continuing until blood counts recover.

Induction therapy repeats every 21-28 days for 2 courses in the absence of disease
progression or unacceptable toxicity. Rituximab may be omitted during course 1 if
circulating mantle cells are excessive. Patients may receive a third course if more than 15%
persistent bone marrow involvement is documented.

Patients with stable or responding disease begin consolidation therapy 29 days after the
start of the final course of induction therapy. Patients receive cytarabine IV over 2 hours
twice daily and etoposide IV over 96 hours on days 1-4. Patients also receive rituximab IV
over 4-6 hours on days 5 or 6 and 12 or 13 and G-CSF SC beginning on day 14 and continuing
until leukapheresis is complete. Patients undergo leukapheresis beginning between days 22-25
and continuing until adequate CD34 cells are collected.

Beginning 4 weeks after recovery from consolidation therapy, patients receive high-dose
therapy comprising carmustine IV over 2 hours on day -6, etoposide IV over 4 hours on day
-4, and cyclophosphamide IV over 2 hours on day -2. Patients undergo autologous peripheral
blood stem cell (PBSC) transplantation on day 0. Patients receive G-CSF SC beginning on day
6 and continuing until blood counts recover.

After blood counts recover and more than 35 days after autologous PBSC transplantation,
patients receive rituximab IV over 4-6 hours weekly for 2 weeks.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
annually for up to 10 years.

PROJECTED ACCRUAL: At least 45 patients will be accrued for this study within 2 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed mantle cell lymphoma

- Presenting with at least one of the following:

- Coexpression of CD20 (or CD19) and CD5 and a lack of CD23 expression by
immunophenotyping

- Positive for cyclin D1 by immunostaining

- Presence of t(11,14) by cytogenetic analysis

- Molecular evidence of bcl-1/IgH rearrangement

- Stage I-IV disease

- Stage III or IV if nodular histology mantle cell lymphoma present

- Any stage for other mantle cell histologies

- No mantle zone histology

- No active CNS disease

- No symptomatic meningeal lymphoma

- No known CNS parenchymal lymphoma

- Lumbar puncture showing mantle cell lymphoma allowed

- Bidimensionally measurable disease greater than 1 cm

- Nonmeasurable disease includes the following:

- Bone lesions

- Leptomeningeal disease

- Ascites

- Pleural/pericardial effusion

- Inflammatory breast disease

- Lymphangitis cutis/pulmonis

- Abdominal masses not confirmed and followed by imaging techniques

- Cystic lesions

- Lesions in a previously irradiated area

PATIENT CHARACTERISTICS:

Age:

- 18 to 69

Performance status:

- Not specified

Life expectancy:

- Not specified

Hematopoietic:

- Not specified

Hepatic:

- Hepatitis B surface antigen and hepatitis C antibody positive patients must meet all
of the following criteria:

- Bilirubin no greater than 2 times upper limit of normal (ULN)

- AST no greater than 3 times ULN

- Liver biopsy shows no greater than grade 2 fibrosis and no cirrhosis

Renal:

- Creatinine no greater than 2.0 mg/dL

Cardiovascular:

- LVEF at least 45% by MUGA or echocardiogram

Other:

- No known hypersensitivity to murine products

- HIV negative

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- No more than 1 prior dose of rituximab

Chemotherapy:

- No more than 1 prior cycle of chemotherapy

- At least 3 weeks since prior chemotherapy

- No other concurrent chemotherapeutic agents

Endocrine therapy:

- No chronic use of oral corticosteroids for ongoing medical condition

- No concurrent hormonal therapy except for non-lymphoma-related conditions (e.g.,
insulin for diabetes)

- Other concurrent corticosteroids for adrenal failure, diffuse alveolar hemorrhage,
carmustine pneumonitis, or as an anti-emetic allowed

Radiotherapy:

- No prior radiotherapy for mantle cell lymphoma

- Concurrent palliative radiotherapy allowed

- Concurrent cranial radiotherapy for asymptomatic meningeal lymphoma allowed

Surgery:

- At least 2 weeks since prior major surgery

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression Free Survival

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Lloyd Damon, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of California, San Francisco

Authority:

United States: Federal Government

Study ID:

CDR0000068732

NCT ID:

NCT00020943

Start Date:

June 2001

Completion Date:

September 2009

Related Keywords:

  • Lymphoma
  • stage I mantle cell lymphoma
  • contiguous stage II mantle cell lymphoma
  • noncontiguous stage II mantle cell lymphoma
  • stage III mantle cell lymphoma
  • stage IV mantle cell lymphoma
  • Lymphoma
  • Lymphoma, Mantle-Cell

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Walter Reed Army Medical CenterWashington, District of Columbia  20307-5000
University of Chicago Cancer Research CenterChicago, Illinois  60637
University of Minnesota Cancer CenterMinneapolis, Minnesota  55455
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
CCOP - Kansas CityKansas City, Missouri  64131
CCOP - Southern Nevada Cancer Research FoundationLas Vegas, Nevada  89106
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - Mount Sinai Medical CenterMiami Beach, Florida  33140
CCOP - North Shore University HospitalManhasset, New York  11030
CCOP - Southeast Cancer Control ConsortiumWinston-Salem, North Carolina  27104-4241
MBCCOP - Massey Cancer CenterRichmond, Virginia  23298-0037
CCOP - Illinois Oncology Research AssociationPeoria, Illinois  61602
Comprehensive Cancer Center at Wake Forest UniversityWinston-Salem, North Carolina  27157-1082
Veterans Affairs Medical Center - BirminghamBirmingham, Alabama  35233
Western Pennsylvania HospitalPittsburgh, Pennsylvania  15224
Green Mountain Oncology GroupRutland, Vermont  05701
Martha Jefferson HospitalCharlottesville, Virginia  22901
CCOP - Northern Indiana CR ConsortiumSouth Bend, Indiana  46601
Holden Comprehensive Cancer Center at University of IowaIowa City, Iowa  52242-1002
UMASS Memorial Cancer Center - University CampusWorcester, Massachusetts  01605-2982
Ellis Fischel Cancer Center at University of Missouri - ColumbiaColumbia, Missouri  65203
Siteman Cancer Center at Barnes-Jewish HospitalSaint Louis, Missouri  63110
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical CenterLebanon, New Hampshire  03756-0002
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillChapel Hill, North Carolina  27599-7570
North Shore University HospitalManhasset, New York  11030
Veterans Affairs Medical Center - Chicago (Westside Hospital)Chicago, Illinois  60612
Naval Medical Center - San DiegoSan Diego, California  92134-3202
Veterans Affairs Medical Center - San FranciscoSan Francisco, California  94121
Baptist Hospital East - LouisvilleLouisville, Kentucky  40207
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.Syracuse, New York  13217
Veterans Affairs Medical Center - MemphisMemphis, Tennessee  38104
Veterans Affairs Medical Center - MinneapolisMinneapolis, Minnesota  55417
Veterans Affairs Medical Center - Columbia (Truman Memorial)Columbia, Missouri  65201
Veterans Affairs Medical Center - BuffaloBuffalo, New York  14215
Veterans Affairs Medical Center - SyracuseSyracuse, New York  13210
Veterans Affairs Medical Center - DurhamDurham, North Carolina  27705
Rebecca and John Moores UCSD Cancer CenterLa Jolla, California  92093-0658
Broward General Medical CenterFort Lauderdale, Florida  33316
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer InstituteBoston, Massachusetts  02115
Northeast Alabama Regional Medical CenterAnniston, Alabama  36207
Veterans Affairs Medical Center - San DiegoSan Diego, California  92161
UCSF Comprehensive Cancer CenterSan Francisco, California  94115
Veterans Affairs Medical Center - Washington, DCWashington, District of Columbia  20422
Louis A. Weiss Memorial HospitalChicago, Illinois  60640
West Suburban Center for Cancer CareRiver Forest, Illinois  60305
Fort Wayne Medical Oncology and Hematology, IncorporatedFort Wayne, Indiana  46885-5099
Veterans Affairs Medical Center - Las VegasLas Vegas, Nevada  89106
Cooper University HospitalCamden, New Jersey  08103
Elmhurst Hospital CenterElmhurst, New York  11373
Queens Cancer Center of Queens HospitalJamaica, New York  11432
Veterans Affairs Medical Center - AshevilleAsheville, North Carolina  28805
Cape Fear Valley Health SystemFayetteville, North Carolina  28302-2000
Lenoir Memorial Hospital Cancer CenterKinston, North Carolina  28503-1678
FirstHealth Moore Regional HospitalPinehurst, North Carolina  28374
Lifespan: The Miriam HospitalProvidence, Rhode Island  02906
University of Tennessee Cancer InstituteMemphis, Tennessee  38103
Veterans Affairs Medical Center - DallasDallas, Texas  75216
Virginia Oncology Associates - NorfolkNorfolk, Virginia  23502
St. Mary's Medical CenterHuntington, West Virginia  25701
Oklahoma University Medical CenterOklahoma City, Oklahoma  73104
Mount Sinai Medical CenterNew York, New York  10029
Vermont Cancer Center at University of VermontBurlington, Vermont  05405-0075
Lombardi Cancer Center at Georgetown University Medical CenterWashington, District of Columbia  20007
Greenebaum Cancer Center at University of Maryland Medical CenterBaltimore, Maryland  21201
UNMC Eppley Cancer Center at the University of Nebraska Medical CenterOmaha, Nebraska  68198-7680
New Hampshire Oncology-Hematology, PA - HooksettHooksett, New Hampshire  03106
NorthEast Oncology Associates - ConcordConcord, North Carolina  28025
Arthur G. James Cancer Hospital at Ohio State UniversityColumbus, Ohio  43210-1240
Oncology and Hematology Associates of Southwest Virginia, Incorporated - RoanokeRoanoke, Virginia  24014
Lakeland Cancer Care Center at Lakeland Hospital - St. JosephSaint Joseph, Michigan  49085
New York Weill Cornell Cancer Center at Cornell UniversityNew York, New York  10021
Zimmer Cancer Center at New Hanover Regional Medical CenterWilmington, North Carolina  28402-9025
Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical CenterLos Angeles, California  90048
University Hospital at State University of New York - Upstate Medical UniversitySyracuse, New York  13210
Memorial Regional Cancer Center at Memorial Regional HospitalHollywood, Florida  33021
Missouri Baptist Cancer CenterSt. Louis, Missouri  63131
Palm Beach Cancer InstituteWest Palm Beach, Florida  33401
Hematology/Oncology Faculty PracticeSan Francisco, California  94143-0324