Chemotherapy and Radiation Therapy Plus Bone Marrow Transplantation in Treating Patients With Aggressive Non-Hodgkin's Lymphoma
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Lymphoma
Intervention: bleomycin (Drug); carmustine (Drug); cyclophosphamide (Drug); cytarabine (Drug); doxorubicin hydrochloride (Drug); etoposide (Drug); melphalan (Drug); prednisolone (Drug); vincristine (Drug); autologous bone marrow transplantation (Procedure); radiation therapy (Procedure)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: Scotland and Newcastle Lymphoma Group Official(s) and/or principal investigator(s):
Stephen J. Proctor, MD, FRCP, FRCPath, Study Chair, Affiliation: Newcastle-upon-Tyne Hospitals NHS Trust
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer
cells. Bone marrow transplantation may allow doctors to give higher doses of chemotherapy
drugs and kill more cancer cells.
PURPOSE: Randomized phase III trial to study the effectiveness of chemotherapy and radiation
therapy plus bone marrow transplantation in treating patients who have aggressive
non-Hodgkin's lymphoma.
Clinical Details
Official title: A Randomised Study of High Dose Chemotherapy/Radiotherapy and Autologous Bone Marrow Transplantation in Patients With High Grade Malignant Non-Hodgkin's Lymphoma (Kiel Classification) According to Prognostic Groups
Study design: Treatment, Randomized, Placebo Control
Detailed description:
OBJECTIVES:
- Assess the rate of remission in patients with aggressive non-Hodgkin's lymphoma treated
with high-dose chemotherapy and radiotherapy plus autologous bone marrow
transplantation.
- Determine the efficacy and toxic effects of this regimen in these patients.
OUTLINE: This is a randomized, placebo-controlled, multicenter study. Patients are stratified
according to risk group (good vs intermediate vs poor).
Patients undergo harvest of autologous bone marrow stem cells after priming chemotherapy and
before transplantation.
Patients receive induction chemotherapy comprising the CHOP or VAPEC-B regimen. The CHOP
regimen consists of vincristine (VCR) IV, cyclophosphamide (CTX) IV, and doxorubicin (DOX) IV
on day 1 and oral prednisolone (PRDL) on days 1-5. Treatment repeats every 3 weeks for six
courses. The VAPEC-B regimen consists of DOX IV on days 1, 15, 29, 43, 57, and 71; CTX IV on
days 1, 29, and 57; VCR IV on days 8, 22, 36, 50, and 64; bleomycin IV on days 8, 36, 64;
oral etoposide (VP-16) on days 15-19, 43-47, and 71-75; and oral PRDL daily for 13 weeks.
Patients then may undergo radiotherapy for 2-3 weeks to areas of original bulk or residual
disease.
- Good-risk group: Patients are randomized to one of two treatment arms.
- Arm I: Patients receive no further treatment.
- Arm II: Patients receive melphalan (L-PAM) before or after total body irradiation
(TBI), which is delivered in 3 fractions over 24 hours. After completion of
radiotherapy, patients undergo autologous bone marrow transplantation (AuBMT).
- Intermediate- or poor-risk group: Patients are randomized one of three treatment arms.
- Arm III: Patients receive L-PAM IV on day -2 and AuBMT on day 0.
- Arm IV: Patients receive treatment as in arm II.
- Arm V: Patients receive carmustine IV on day -6, VP-16 IV once daily and cytarabine IV twice daily on days - 5 to -2, and L-PAM IV on day -1. Radiotherapy to bulk
disease begins after completion of chemotherapy. Patients undergo AuBMT on day 0.
Patients are followed monthly for 3 months, every 2 months for 1 year, every 4 months for 2
years, and then every 6 months thereafter.
PROJECTED ACCRUAL: Not specified
Eligibility
Minimum age: 15 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
DISEASE CHARACTERISTICS:
- Histologically confirmed aggressive non-Hodgkin's lymphoma requiring chemotherapy
- Stage II, III, or IV
- B cell:
- Centroblastic
- Immunoblastic
- Large cell anaplastic
- Non-Burkitt lymphoblastic
- T cell:
- Pleomorphic medium cell
- Pleomorphic large cell
- Immunoblastic
- Large cell anaplastic
- Lymphoblastic
- No Burkitt (L3) subtype
- No large mediastinal mass OR
- Stage I, II, III, or IV
- Bulk disease greater than 10 cm
- Nodal or extranodal site
- No primary localized gut lymphoma
- No CNS involvement
PATIENT CHARACTERISTICS:
Age:
- 15 to 65
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- No concurrent bone marrow dysplastic syndromes
Hepatic:
- Bilirubin no greater than 2. 5 times upper limit of normal (ULN)
Renal:
- Creatinine no greater than 2. 5 times ULN
Other:
- No other malignancy except skin cancer or stage I cervical cancer
- Not pregnant
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- See Disease Characteristics
- No prior chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- Not specified
Surgery:
- Not specified
Locations and Contacts
Newcastle Upon Tyne Hospitals NHS Trust, Newcastle-Upon-Tyne, England NE1 4LP, United Kingdom
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: June 1994
Last updated: May 23, 2008
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