Combination Chemotherapy in Treating Patients With Lymphoma
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ClinicalTrials.gov Identifier: NCT00002835 |
Recruitment Status :
Completed
First Posted : April 16, 2003
Last Update Posted : November 15, 2018
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RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.
PURPOSE: Randomized phase III trial to compare the effectiveness of two regimens of combination chemotherapy in treating patients who have intermediate-grade or immunoblastic lymphoma.
Condition or disease | Intervention/treatment | Phase |
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Lymphoma | Biological: Bleomycin Sulfate (BLM) Biological: Filgrastim (G-CSF) Biological: Recombinant Interferon Alfa Drug: Carmustine Drug: Cisplatin (CDDP) Drug: Cyclophosphamide Drug: Cytarabine (ARA-C) Drug: Etoposide (VP-16) Drug: Idarubicin Drug: Ifosfamide Drug: Leucovorin Calcium Drug: Melphalan Drug: Methotrexate Drug: Methylprednisolone Drug: mitoxantrone hydrochloride (DHAD) Drug: Vincristine Sulfate Procedure: Peripheral Blood Stem Cell Transplantation Radiation: Radiation Therapy | Phase 3 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 116 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Randomized Prospective Study of Early Intensification Versus Alternating Triple Therapy for Patients With Poor Prognosis Lymphoma |
Actual Study Start Date : | October 30, 1995 |
Actual Primary Completion Date : | February 4, 2004 |
Actual Study Completion Date : | February 4, 2004 |

Arm | Intervention/treatment |
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Experimental: Arm I
3 courses of early intensification: First course: Ifosfamide (IFF) IV continuously and Etoposide (VP-16) IV over 2 hours every 12 hours on days 1-3. Filgrastim (G-CSF) administered subcutaneously (SC) beginning on day 5 and continuing until blood counts recover then autologous peripheral blood stem cells (PBSC) are harvested, selected for CD34 positive cells, and purged in vitro. If more than 5% of the WBC contains lymphoma cells after induction, then 2 courses of IFF and VP-16 are administered before PBSC harvest. Second course: IFF IV continuously on days 1-3, mitoxantrone (DHAD) IV on day 1, and G-CSF SC as in first course. Third course: Carmustine IV over 1 hour on day -6, ARA-C and VP-16 IV every 12 hours on days -5 to -2, and melphalan IV on day -1. PBSC are reinfused on day 0. G-CSF is administered SC beginning on day 0 and continuing until blood counts recover. Each course lasts 3 weeks in the absence of disease progression or unacceptable toxicity. |
Biological: Filgrastim (G-CSF)
Arm 1: Administered subcutaneously (SC) beginning on day 5 and continuing until blood counts recover through Course 1 then 2 courses administered before PBSC harvest and same regimen with Course 2, then daily with Day 0 of infusion.
Other Names:
Drug: Carmustine Arm 1, Course 3, IV over 1 hour on day -6.
Other Names:
Drug: Cytarabine (ARA-C) Arm 1, Course 3, every 12 hours on days -5 to -2.
Other Names:
Drug: Etoposide (VP-16) Course 1, IV over 2 hours every 12 hours on days 1-3; Course 3, every 12 hours on days -5 to -2.
Other Name: VePesid Drug: Ifosfamide During Course 1, IV continuously; Course 2, IV continuously on days 1-3.
Other Name: Ifex Drug: Melphalan Other Name: Alkeran Drug: mitoxantrone hydrochloride (DHAD) Arm 1, Course 2, IV on day 1.
Other Names:
Procedure: Peripheral Blood Stem Cell Transplantation Infusion of stem cells on Day 0.
Other Names:
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Experimental: Arm II
IDSHAP during 4 week courses 2 and 5, MBIDCOS during courses 3 and 6, and IFF and VP-16 IV over 1 hour on days 1-3 and DHAD IV over 15 minutes on day 1 during courses 1, 4, and 7.
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Biological: Bleomycin Sulfate (BLM)
Other Names:
Biological: Recombinant Interferon Alfa Drug: Cisplatin (CDDP) Other Names:
Drug: Cyclophosphamide Other Names:
Drug: Idarubicin Other Name: Idamycin Drug: Leucovorin Calcium Other Names:
Drug: Methotrexate Drug: Methylprednisolone Other Names:
Drug: Vincristine Sulfate Procedure: Peripheral Blood Stem Cell Transplantation Infusion of stem cells on Day 0.
Other Names:
Radiation: Radiation Therapy Other Name: RT |
- Efficacy of Early Intensification vs. Alternating Triple Chemotherapy [ Time Frame: Monthly ]

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Ages Eligible for Study: | 15 Years to 59 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
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Diagnosis of previously untreated intermediate-grade or immunoblastic lymphoma
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Tumor score of 3 or greater, defined by the presence of 3 or more of the following criteria :
- Ann Arbor stage III or IV disease
- B symptoms (fever, sweats, and weight loss greater than 10%)
- At least 1 tumor mass greater than 7 cm or mediastinal mass visible on plain chest x-ray
- Beta-2 microglobulin at least 3.0
- Lactic dehydrogenase at least 1.1 times the upper limit of normal
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- T- and B-cell lymphomas allowed if intermediate grade or immunoblastic
- Divergent histologies, including bone marrow involvement, allowed
- CNS involvement allowed NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.
PATIENT CHARACTERISTICS:
Age:
- 15 to 59
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Bilirubin less than 2.0 mg/dL (unless elevation due to lymphoma)
Renal:
- Creatinine no greater than 1.5 mg/dL (unless elevation due to lymphoma)
Cardiovascular:
- LVEF greater than 50% by echocardiogram if over age 45
- No congestive heart failure, angina, history of myocardial infarction, or arrhythmia unless cleared by principal investigator after cardiology consultation
Pulmonary:
- No history of chronic obstructive or restrictive lung disease
- Pulmonary consultation required for smokers or patients with questionable lung function
Other:
- HIV negative
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No prior malignancy with poor prognosis (less than 90% probability of surviving for 5 years)
- No geographic, economic, emotional, or social condition that would preclude study
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No prior biologic therapy
Chemotherapy
- No prior chemotherapy
Endocrine therapy
- No prior endocrine therapy
Radiotherapy
- No prior radiotherapy
Surgery
- Not specified

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002835
United States, Texas | |
University of Texas - MD Anderson Cancer Center | |
Houston, Texas, United States, 77030-4009 |
Study Chair: | Richard E. Champlin, MD | M.D. Anderson Cancer Center |
Responsible Party: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00002835 |
Obsolete Identifiers: | NCT00038740 |
Other Study ID Numbers: |
MDA DM95-121 P30CA016672 ( U.S. NIH Grant/Contract ) MDA-DM-95121 ( Other Identifier: UT MD Anderson Cancer Center ) NCI-V96-1010 CDR0000065044 ( Registry Identifier: NCI PDQ ) |
First Posted: | April 16, 2003 Key Record Dates |
Last Update Posted: | November 15, 2018 |
Last Verified: | November 2018 |
stage I grade 3 follicular lymphoma stage I adult diffuse small cleaved cell lymphoma stage I adult diffuse mixed cell lymphoma stage I adult diffuse large cell lymphoma stage I adult immunoblastic large cell lymphoma stage III grade 3 follicular lymphoma stage III adult diffuse small cleaved cell lymphoma stage III adult diffuse mixed cell lymphoma stage III adult diffuse large cell lymphoma stage III adult immunoblastic large cell lymphoma stage IV grade 3 follicular lymphoma stage IV adult diffuse small cleaved cell lymphoma stage IV adult diffuse mixed cell lymphoma |
stage IV adult diffuse large cell lymphoma stage IV adult immunoblastic large cell lymphoma contiguous stage II grade 3 follicular lymphoma contiguous stage II adult diffuse small cleaved cell lymphoma contiguous stage II adult diffuse mixed cell lymphoma contiguous stage II adult immunoblastic large cell lymphoma contiguous stage II adult diffuse large cell lymphoma noncontiguous stage II grade 3 follicular lymphoma noncontiguous stage II adult diffuse small cleaved cell lymphoma noncontiguous stage II adult diffuse mixed cell lymphoma noncontiguous stage II adult immunoblastic large cell lymphoma noncontiguous stage II adult diffuse large cell lymphoma |
Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Leucovorin Interferons Cytarabine Interferon-alpha Methylprednisolone Methylprednisolone Acetate Methylprednisolone Hemisuccinate Prednisolone |
Prednisolone acetate Cyclophosphamide Melphalan Ifosfamide Carmustine Cisplatin Methotrexate Etoposide Vincristine Mitoxantrone Idarubicin Bleomycin Levoleucovorin Prednisolone hemisuccinate Prednisolone phosphate |