Rituximab With Combination Chemotherapy or Bendamustine Hydrochloride Followed by Consolidation Chemotherapy and Stem Cell Transplantation in Older Patients With Previously Untreated Mantle Cell Lymphoma
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and help kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy also work in different ways to kill more cancer cells or stop them from growing. It is not yet known whether rituximab is more effective with combination chemotherapy or bendamustine hydrochloride in treating patients with mantle cell lymphoma undergoing peripheral blood stem cell transplantation.
PURPOSE: This randomized phase II trial studies how well giving rituximab together with combination chemotherapy or bendamustine hydrochloride followed by consolidation chemotherapy and peripheral blood stem cell transplantation works in treating older patients with previously untreated mantle cell lymphoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Biological: rituximab Drug: bendamustine hydrochloride Drug: cyclophosphamide Drug: cytarabine Drug: dexamethasone Drug: doxorubicin hydrochloride Drug: leucovorin calcium Drug: methotrexate Drug: vincristine sulfate |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomized Phase II Trial of R-HCVAD/MTX/ARA-C Induction Followed by Consolidation With an Autologous Stem Cell Transplant Vs. R-Bendamustine Induction Followed by Consolidation With an Autologous Stem Cell Transplant for Patients ≤ 65 Years of Age With Previously Untreated Mantle Cell Lymphoma |
- PFS at 2 years [ Designated as safety issue: No ]
- Toxicity of R-HCVAD/MTX/Ara-C and autologous stem cell transplant (ASCT) or R-bendamustine and ASCT [ Designated as safety issue: Yes ]
- Response rate in patients treated with these regimens [ Designated as safety issue: No ]
- Overall survival of patients treated with these regimens [ Designated as safety issue: No ]
| Estimated Enrollment: | 180 |
| Study Start Date: | November 2011 |
| Estimated Primary Completion Date: | December 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm I
Course 1 and 3: Patients receive induction therapy comprising rituximab IV on day 1; cyclophosphamide IV over 3 hours every 12 hours on days 2-4; doxorubicin hydrochloride IV over 72 hours on days 5-7; vincristine sulfate IV on days 5 and 12; and dexamethasone IV or orally (PO) once daily (QD) on days 2-5 and 12-15. Patients with responsive disease after course 1 proceed to course 2. Course 2 and 4: Patients receive rituximab IV on day 1; methotrexate IV over 2-22 hours on day 2; cytarabine IV over 2 hours every 12 hours on days 3-4; and leucovorin calcium PO or IV on days 3-6. Patients then undergo stem cell collection after completion of course 2. Patients undergo stem cell collection after completion of course 2.
|
Biological: rituximab
Given IV
Drug: cyclophosphamide
Given IV
Drug: cytarabine
Given IV
Drug: dexamethasone
Given PO or IV
Drug: doxorubicin hydrochloride
Given IV
Drug: leucovorin calcium
Given PO or IV
Drug: methotrexate
Given IV
Drug: vincristine sulfate
Given IV
|
|
Experimental: Arm II
Course 1-6: Patients receive rituximab IV on day 1 and bendamustine hydrochloride IV over 30 minutes on days 1-2. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Beginning 3-4 weeks later, patients with responsive disease receive 2 additional courses of treatment. Beginning within 8 weeks, patients receive rituximab IV and cyclophosphamide IV over 1 hour on day 1. Patients then undergo stem cell collection about 26 days later.
|
Biological: rituximab
Given IV
Drug: bendamustine hydrochloride
Given IV
Drug: cyclophosphamide
Given IV
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
All patients must have previously untreated stage III, IV, or bulky stage II mantle cell lymphoma (MCL)
A diagnosis of MCL must be confirmed by histopathological diagnosis including immunohistochemistry and flow cytometry documenting both of the following phenotypes:
- CD19+ or CD20+
- Cyclin D1+ or evidence of the t(11;14) translocation by cytogenetics or FISH
Adequate sections from the original diagnostic specimen must be available for submission for central review
An adequate biopsy requires sufficient tissue to establish the architecture and a WHO histologic subtype with certainty
- Core biopsies, especially multiple core biopsies, MAY be adequate, but needle aspirations or cytologies are not adequate
- Bone marrow core biopsy or clot sections (not aspirates) may be used as diagnostic material if it is significantly involved and are the only diagnostic material available
All patients must have bidimensional measurable disease documented on the Lymphoma Baseline Tumor Assessment Form (Form #48031)
- Patients who also have non-measurable disease in addition to measurable disease must have all nonmeasurable disease assessed within 28 days prior to registration
Patients must not have clinical evidence of central nervous system (CNS) involvement by lymphoma
- Any laboratory or radiographic tests performed prior to registration to assess CNS involvement must be negative
Patients must have a unilateral/bilateral bone marrow aspirate and biopsy for staging performed within 42 days prior to registration
- If the biopsy cannot be performed but the aspirate is unequivocally consistent with mantle cell lymphoma, this will be considered adequate for staging purposes
Patients must be eligible for stem cell transplantation by institutional guidelines with the plan that transplant will be conducted at a cooperative group-approved transplant center
- Patients must be planning to undergo stem cell transplantation within 84 days after day 1 of the last induction course
- Patients must have had at least 1.5 X 10^6 CD34^+ cells/kg collected and stored prior to second registration for stem cell transplantation
PATIENT CHARACTERISTICS:
- Zubrod performance status of 0-2
- Bilirubin ≤ 3 times upper limit of normal (ULN)
- Serum creatinine ≤ 2.0 times ULN
- ALT and AST ≤ 2.5 times ULN
- Alkaline phosphatase ≤ 2.5 times ULN
- Platelet count ≥ 100,000/mcL, unless due to bone marrow infiltration by lymphoma
All patients ≥ 45 years of age must have an echocardiogram (ECHO) or MUGA scan within 42 days prior to registration (whichever method is used at baseline must be used at restaging)
- Patients < 45 years of age should have ECHO/MUGA only if clinically indicated
- Patients with an ejection fraction < institutional lower limit of normal (ILLN) are not eligible
- Serum LDH and a CBC with differential must be measured within 28 days prior to registration
- Patients known to be HIV positive, or who have a history of solid organ transplantation, are ineligible
- No active hepatitis
- No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer; in situ cervical cancer; adequately treated Stage I or II cancer from which the patient is currently in complete remission; or any other cancer from which the patient has been disease-free for 5 years
- Pregnant or nursing women may not participate
- Women or men of reproductive potential may not participate unless they have agreed to use an effective contraceptive method
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Contacts and Locations
Show 204 Study Locations| Principal Investigator: | Steven H. Bernstein, MD | James P. Wilmot Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Laurence H. Baker, Southwest Oncology Group - Group Chair's Office |
| ClinicalTrials.gov Identifier: | NCT01412879 History of Changes |
| Other Study ID Numbers: | CDR0000707601, SWOG-S1106 |
| Study First Received: | August 6, 2011 |
| Last Updated: | October 7, 2012 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
contiguous stage II mantle cell lymphoma noncontiguous stage II mantle cell lymphoma stage III mantle cell lymphoma stage IV mantle cell lymphoma |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, Mantle-Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, Non-Hodgkin Cyclophosphamide Cytarabine Methotrexate Rituximab Nitrogen Mustard Compounds Bendamustine |
Dexamethasone Doxorubicin Vincristine Dexamethasone acetate Dexamethasone 21-phosphate BB 1101 Leucovorin Levoleucovorin Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents, Alkylating |
ClinicalTrials.gov processed this record on May 23, 2013